PAS Annual Meeting 2015

SAN DIEGO – Any child diagnosed with neonatal diabetes should undergo genetic testing for monogenic mutations as quickly as possible, and a case can be made for switching from insulin injections to empiric oral sulfonylurea therapy while awaiting the test results, Dr. Siri A. Greeley asserted at the annual meeting of the Pediatric Academic Societies.

“I think the situation is analogous to congenital hypothyroidism, where early treatment is really important while the brain is still developing. I think sulfonylureas’ effects on brain function are age dependent. That’s one of my main rationales for starting sulfonylurea therapy early on, especially if you’re having trouble getting the genetic testing done,” explained Dr. Greeley, a pediatric endocrinologist at the University of Chicago.

Diabetes diagnosed before age 6 months is nearly always genetic in origin. Heterozygous activating mutations of the adenosine triphosphate (ATP)-sensitive potassium channel (KATP) cause up to 60% of diabetes diagnosed before 6 months of age. Sulfonylurea therapy is typically highly effective in these children, and the sooner they start therapy the better their outcomes, both in terms of glycemic control and neurodevelopmental endpoints, he said.

In his recent retrospective observational study of 58 patients enrolled in the University of Chicago Monogenic Diabetes Registry who had neonatal diabetes involving the KCNJ11 subunit of the KATP channel, hemoglobin A_1c fell from an average of 8.5% on insulin to 6.2% after the transition to sulfonylurea therapy. Age at initiation of sulfonylureas showed a linear correlation with the dose required at follow-up. Indeed, all 10 patients who needed additional glucose-lowering medications along with their sulfonylurea had started on sulfonylurea therapy at age 13 years or older (Diabetologia 2015 April 17 [Epub ahead of print] PMID:25877689).

A likely possible explanation for the observed decline in sensitivity to sulfonylureas with an older starting age is that insulin-treated patients experience loss of beta cell mass over time, according to Dr. Greeley.

A syndrome known by the acronym DEND, for developmental delay, epilepsy, and neonatal diabetes, affects 20%-30% of patients with neonatal diabetes related to mutations in the KATP channel. These channels are widely expressed in the brain.

The first hint that early initiation of sulfonylureas in children with KATP-related neonatal diabetes may have beneficial neurodevelopmental effects has been provided by a study Dr. Greeley and coinvestigators conducted in 19 patients, aged 2-20 years, with KATP channel mutations. Eight had diabetes only, eight had DEND, all eight of whom had potent V59M/A mutations, and three had other KATP-related mutations associated with milder neurodevelopmental impairment. Upon testing via the age-standardized Beery-Buktenica Developmental Test of Visual-Motor Integration, the investigators found that the group with diabetes only had normal scores while those with V59M/A mutations scored quite low. The key finding: Age at sulfonylurea initiation was inversely associated with scores on the Beery test. Those who started on the medication before 1 year of age had near-normal scores (Diabetes Care 2012;35:2086-8).

That’s not definitive evidence, Dr. Greeley observed. It needs to be confirmed with larger patient numbers. But it does warrant at least considering preemptive sulfonylurea therapy while awaiting genetic test results in patients with neonatal diabetes, he said.

He noted that in his retrospective study of 154 subjects diagnosed with diabetes before age 6 months, barriers to expeditious genetic testing, mainly consisting of obstacles created by insurance companies, resulted in a median time between clinical diagnosis and genetic diagnosis of 10.4 weeks (J. Clin. Endocrinol. Metab. 2014;99:E2709-14).

Neonatal diabetes is a rare condition. Most of the culprit mutations are de novo, not inherited. With an incidence of roughly 1 in 100,000 births, the rate is in line with other disorders that are part of standard newborn screening, such as maple syrup urine disease, Dr. Greeley observed.

More than 70% of all cases of neonatal diabetes are due to mutations at one of four loci: 6q24, KCNJ11, INS, or ABCC8. It’s important to order genetic testing from a laboratory that includes a comprehensive 6q24 analysis in its panel; many don’t, creating the potential for a false-negative test result, the pediatric endocrinologist cautioned.

Dr. Greeley’s research is funded by the National Institutes of Health, the American Diabetes Association, and the Kovler Family Foundation. He reported having no financial conflicts.

[email protected]

SAN DIEGO – Any child diagnosed with neonatal diabetes should undergo genetic testing for monogenic mutations as quickly as possible, and a case can be made for switching from insulin injections to empiric oral sulfonylurea therapy while awaiting the test results, Dr. Siri A. Greeley asserted at the annual meeting of the Pediatric Academic Societies.

“I think the situation is analogous to congenital hypothyroidism, where early treatment is really important while the brain is still developing. I think sulfonylureas’ effects on brain function are age dependent. That’s one of my main rationales for starting sulfonylurea therapy early on, especially if you’re having trouble getting the genetic testing done,” explained Dr. Greeley, a pediatric endocrinologist at the University of Chicago.

Diabetes diagnosed before age 6 months is nearly always genetic in origin. Heterozygous activating mutations of the adenosine triphosphate (ATP)-sensitive potassium channel (KATP) cause up to 60% of diabetes diagnosed before 6 months of age. Sulfonylurea therapy is typically highly effective in these children, and the sooner they start therapy the better their outcomes, both in terms of glycemic control and neurodevelopmental endpoints, he said.

In his recent retrospective observational study of 58 patients enrolled in the University of Chicago Monogenic Diabetes Registry who had neonatal diabetes involving the KCNJ11 subunit of the KATP channel, hemoglobin A_1c fell from an average of 8.5% on insulin to 6.2% after the transition to sulfonylurea therapy. Age at initiation of sulfonylureas showed a linear correlation with the dose required at follow-up. Indeed, all 10 patients who needed additional glucose-lowering medications along with their sulfonylurea had started on sulfonylurea therapy at age 13 years or older (Diabetologia 2015 April 17 [Epub ahead of print] PMID:25877689).

A likely possible explanation for the observed decline in sensitivity to sulfonylureas with an older starting age is that insulin-treated patients experience loss of beta cell mass over time, according to Dr. Greeley.

A syndrome known by the acronym DEND, for developmental delay, epilepsy, and neonatal diabetes, affects 20%-30% of patients with neonatal diabetes related to mutations in the KATP channel. These channels are widely expressed in the brain.

The first hint that early initiation of sulfonylureas in children with KATP-related neonatal diabetes may have beneficial neurodevelopmental effects has been provided by a study Dr. Greeley and coinvestigators conducted in 19 patients, aged 2-20 years, with KATP channel mutations. Eight had diabetes only, eight had DEND, all eight of whom had potent V59M/A mutations, and three had other KATP-related mutations associated with milder neurodevelopmental impairment. Upon testing via the age-standardized Beery-Buktenica Developmental Test of Visual-Motor Integration, the investigators found that the group with diabetes only had normal scores while those with V59M/A mutations scored quite low. The key finding: Age at sulfonylurea initiation was inversely associated with scores on the Beery test. Those who started on the medication before 1 year of age had near-normal scores (Diabetes Care 2012;35:2086-8).

That’s not definitive evidence, Dr. Greeley observed. It needs to be confirmed with larger patient numbers. But it does warrant at least considering preemptive sulfonylurea therapy while awaiting genetic test results in patients with neonatal diabetes, he said.

He noted that in his retrospective study of 154 subjects diagnosed with diabetes before age 6 months, barriers to expeditious genetic testing, mainly consisting of obstacles created by insurance companies, resulted in a median time between clinical diagnosis and genetic diagnosis of 10.4 weeks (J. Clin. Endocrinol. Metab. 2014;99:E2709-14).

Neonatal diabetes is a rare condition. Most of the culprit mutations are de novo, not inherited. With an incidence of roughly 1 in 100,000 births, the rate is in line with other disorders that are part of standard newborn screening, such as maple syrup urine disease, Dr. Greeley observed.

More than 70% of all cases of neonatal diabetes are due to mutations at one of four loci: 6q24, KCNJ11, INS, or ABCC8. It’s important to order genetic testing from a laboratory that includes a comprehensive 6q24 analysis in its panel; many don’t, creating the potential for a false-negative test result, the pediatric endocrinologist cautioned.

Dr. Greeley’s research is funded by the National Institutes of Health, the American Diabetes Association, and the Kovler Family Foundation. He reported having no financial conflicts.

[email protected]

SAN DIEGO – Any child diagnosed with neonatal diabetes should undergo genetic testing for monogenic mutations as quickly as possible, and a case can be made for switching from insulin injections to empiric oral sulfonylurea therapy while awaiting the test results, Dr. Siri A. Greeley asserted at the annual meeting of the Pediatric Academic Societies.

“I think the situation is analogous to congenital hypothyroidism, where early treatment is really important while the brain is still developing. I think sulfonylureas’ effects on brain function are age dependent. That’s one of my main rationales for starting sulfonylurea therapy early on, especially if you’re having trouble getting the genetic testing done,” explained Dr. Greeley, a pediatric endocrinologist at the University of Chicago.

Diabetes diagnosed before age 6 months is nearly always genetic in origin. Heterozygous activating mutations of the adenosine triphosphate (ATP)-sensitive potassium channel (KATP) cause up to 60% of diabetes diagnosed before 6 months of age. Sulfonylurea therapy is typically highly effective in these children, and the sooner they start therapy the better their outcomes, both in terms of glycemic control and neurodevelopmental endpoints, he said.

In his recent retrospective observational study of 58 patients enrolled in the University of Chicago Monogenic Diabetes Registry who had neonatal diabetes involving the KCNJ11 subunit of the KATP channel, hemoglobin A_1c fell from an average of 8.5% on insulin to 6.2% after the transition to sulfonylurea therapy. Age at initiation of sulfonylureas showed a linear correlation with the dose required at follow-up. Indeed, all 10 patients who needed additional glucose-lowering medications along with their sulfonylurea had started on sulfonylurea therapy at age 13 years or older (Diabetologia 2015 April 17 [Epub ahead of print] PMID:25877689).

A likely possible explanation for the observed decline in sensitivity to sulfonylureas with an older starting age is that insulin-treated patients experience loss of beta cell mass over time, according to Dr. Greeley.

A syndrome known by the acronym DEND, for developmental delay, epilepsy, and neonatal diabetes, affects 20%-30% of patients with neonatal diabetes related to mutations in the KATP channel. These channels are widely expressed in the brain.

The first hint that early initiation of sulfonylureas in children with KATP-related neonatal diabetes may have beneficial neurodevelopmental effects has been provided by a study Dr. Greeley and coinvestigators conducted in 19 patients, aged 2-20 years, with KATP channel mutations. Eight had diabetes only, eight had DEND, all eight of whom had potent V59M/A mutations, and three had other KATP-related mutations associated with milder neurodevelopmental impairment. Upon testing via the age-standardized Beery-Buktenica Developmental Test of Visual-Motor Integration, the investigators found that the group with diabetes only had normal scores while those with V59M/A mutations scored quite low. The key finding: Age at sulfonylurea initiation was inversely associated with scores on the Beery test. Those who started on the medication before 1 year of age had near-normal scores (Diabetes Care 2012;35:2086-8).

That’s not definitive evidence, Dr. Greeley observed. It needs to be confirmed with larger patient numbers. But it does warrant at least considering preemptive sulfonylurea therapy while awaiting genetic test results in patients with neonatal diabetes, he said.

He noted that in his retrospective study of 154 subjects diagnosed with diabetes before age 6 months, barriers to expeditious genetic testing, mainly consisting of obstacles created by insurance companies, resulted in a median time between clinical diagnosis and genetic diagnosis of 10.4 weeks (J. Clin. Endocrinol. Metab. 2014;99:E2709-14).

Neonatal diabetes is a rare condition. Most of the culprit mutations are de novo, not inherited. With an incidence of roughly 1 in 100,000 births, the rate is in line with other disorders that are part of standard newborn screening, such as maple syrup urine disease, Dr. Greeley observed.

More than 70% of all cases of neonatal diabetes are due to mutations at one of four loci: 6q24, KCNJ11, INS, or ABCC8. It’s important to order genetic testing from a laboratory that includes a comprehensive 6q24 analysis in its panel; many don’t, creating the potential for a false-negative test result, the pediatric endocrinologist cautioned.

Dr. Greeley’s research is funded by the National Institutes of Health, the American Diabetes Association, and the Kovler Family Foundation. He reported having no financial conflicts.

[email protected]

SAN DIEGO – Infants given high-dose acyclovir for the treatment of herpes simplex virus (HSV) infections experienced a number of adverse reactions, including seizure, hypotension, and thrombocytopenia, according to the results of a new study, but it is unclear if the root cause of these events is the drug or the infection itself.

“The dose currently approved by the [Food and Drug Administration] for use in this population for this indication is 10 mg/kg per dose, dosed ever 8 hours, [but] there have been studies that have indicated that a dose of 20 mg/kg per dose every 8 hours is more effective,” said Dr. Jessica E. Ericson, a third-year fellow in a department of pediatrics at Duke University, Durham, N.C., who presented the findings of this retrospective cohort study at the annual meeting of the Pediatric Academic Societies.

Dr. Ericson added that the 20 mg/kg per dose has “been recommended by the American Academy of Pediatrics Committee on Infectious Diseases and is generally considered to be the standard of care for this condition,” but stated that the “discrepancy between the current standard of care and the FDA-approved dose is likely due to a perceived lack of safety data that demonstrate that high-dose acyclovir is safe to use in young infants.”

Levels of elevated creatine, neutropenia, leukopenia, and thrombocytopenia were measured to assess laboratory AEs, with benchmarks set by the investigators for what defined an adverse event (AE) and a serious AE for each outcome measure. For elevated creatine, greater than 1.7 mg/dL was considered an AE and greater than 3.0 mg/dL was considered a serious AE; for neutropenia, an AE was less than 5,000/mm³ and a serious AE was less than 100/mm³; for leukopenia, less than 5,000/mm³ was an AE and less than 2,000/mm³ was a serious AE; and for thrombocytopenia, less than 100,000/mm³ was considered an AE and less than 20,000/mm³ was considered serious.

Clinical AEs were found in 31% of the 359 infants who received a 20 mg/kg per dose every 8 hours, the most common of which were hypotension (16%) and seizure (11%).

Laboratory AEs were less prevalent: 5% had a creatine AE, and 1% had a serious creatine AE; 3% had a neutropenia AE, and 0.3% had a serious neutropenia AE; 12% had a leukopenia AE, and 0.6% had a serious leukopenia AE; and 19% had a thrombocytopenia AE, while 5% had a serious thrombocytopenia AE.

A total of 38 infants (11%) died; no renal failure requiring dialysis was reported.

Previous studies had noted that renal toxicity and thrombocytopenia were expected AEs, Dr. Ericson said. All infants were discharged from a neonatal intensive care unit managed by the Pediatrix Medical Group, and were exposed to acyclovir for no fewer than 14 days specifically for the treatment of HSV infections. All infants were treated for fewer than 120 days, and all data came from the years 2002–2012. Median birth weight was 2,191 g, and median gestational age was 34 weeks.

Regarding limitations to the study, Dr. Ericson explained that there was no control group cohort because “as high-dose acyclovir is used for at least 14 days, typically only with evidence of HSV disease, there is no obvious control group to use for comparison.” Additionally, lab collection was conducted at the discretion of the treating physician, as this wasn’t a standard trial protocol.

Because this trial wasn’t a observational study, Dr. Ericson explained, it’s possible that some of the laboratory events were due to the underlying HSV disease and not the exposure to acyclovir. However, because serious AEs were rare, Dr. Ericson concluded by saying that the high-dose acyclovir should be the preferred treatment option “when neonatal HSV disease is suspected.”

Dr. Ericson did not report any relevant financial disclosures.

[email protected]

SAN DIEGO – Infants given high-dose acyclovir for the treatment of herpes simplex virus (HSV) infections experienced a number of adverse reactions, including seizure, hypotension, and thrombocytopenia, according to the results of a new study, but it is unclear if the root cause of these events is the drug or the infection itself.

“The dose currently approved by the [Food and Drug Administration] for use in this population for this indication is 10 mg/kg per dose, dosed ever 8 hours, [but] there have been studies that have indicated that a dose of 20 mg/kg per dose every 8 hours is more effective,” said Dr. Jessica E. Ericson, a third-year fellow in a department of pediatrics at Duke University, Durham, N.C., who presented the findings of this retrospective cohort study at the annual meeting of the Pediatric Academic Societies.

Dr. Ericson added that the 20 mg/kg per dose has “been recommended by the American Academy of Pediatrics Committee on Infectious Diseases and is generally considered to be the standard of care for this condition,” but stated that the “discrepancy between the current standard of care and the FDA-approved dose is likely due to a perceived lack of safety data that demonstrate that high-dose acyclovir is safe to use in young infants.”

Levels of elevated creatine, neutropenia, leukopenia, and thrombocytopenia were measured to assess laboratory AEs, with benchmarks set by the investigators for what defined an adverse event (AE) and a serious AE for each outcome measure. For elevated creatine, greater than 1.7 mg/dL was considered an AE and greater than 3.0 mg/dL was considered a serious AE; for neutropenia, an AE was less than 5,000/mm³ and a serious AE was less than 100/mm³; for leukopenia, less than 5,000/mm³ was an AE and less than 2,000/mm³ was a serious AE; and for thrombocytopenia, less than 100,000/mm³ was considered an AE and less than 20,000/mm³ was considered serious.

Clinical AEs were found in 31% of the 359 infants who received a 20 mg/kg per dose every 8 hours, the most common of which were hypotension (16%) and seizure (11%).

Laboratory AEs were less prevalent: 5% had a creatine AE, and 1% had a serious creatine AE; 3% had a neutropenia AE, and 0.3% had a serious neutropenia AE; 12% had a leukopenia AE, and 0.6% had a serious leukopenia AE; and 19% had a thrombocytopenia AE, while 5% had a serious thrombocytopenia AE.

A total of 38 infants (11%) died; no renal failure requiring dialysis was reported.

Previous studies had noted that renal toxicity and thrombocytopenia were expected AEs, Dr. Ericson said. All infants were discharged from a neonatal intensive care unit managed by the Pediatrix Medical Group, and were exposed to acyclovir for no fewer than 14 days specifically for the treatment of HSV infections. All infants were treated for fewer than 120 days, and all data came from the years 2002–2012. Median birth weight was 2,191 g, and median gestational age was 34 weeks.

Regarding limitations to the study, Dr. Ericson explained that there was no control group cohort because “as high-dose acyclovir is used for at least 14 days, typically only with evidence of HSV disease, there is no obvious control group to use for comparison.” Additionally, lab collection was conducted at the discretion of the treating physician, as this wasn’t a standard trial protocol.

Because this trial wasn’t a observational study, Dr. Ericson explained, it’s possible that some of the laboratory events were due to the underlying HSV disease and not the exposure to acyclovir. However, because serious AEs were rare, Dr. Ericson concluded by saying that the high-dose acyclovir should be the preferred treatment option “when neonatal HSV disease is suspected.”

Dr. Ericson did not report any relevant financial disclosures.

[email protected]

SAN DIEGO – Infants given high-dose acyclovir for the treatment of herpes simplex virus (HSV) infections experienced a number of adverse reactions, including seizure, hypotension, and thrombocytopenia, according to the results of a new study, but it is unclear if the root cause of these events is the drug or the infection itself.

“The dose currently approved by the [Food and Drug Administration] for use in this population for this indication is 10 mg/kg per dose, dosed ever 8 hours, [but] there have been studies that have indicated that a dose of 20 mg/kg per dose every 8 hours is more effective,” said Dr. Jessica E. Ericson, a third-year fellow in a department of pediatrics at Duke University, Durham, N.C., who presented the findings of this retrospective cohort study at the annual meeting of the Pediatric Academic Societies.

Dr. Ericson added that the 20 mg/kg per dose has “been recommended by the American Academy of Pediatrics Committee on Infectious Diseases and is generally considered to be the standard of care for this condition,” but stated that the “discrepancy between the current standard of care and the FDA-approved dose is likely due to a perceived lack of safety data that demonstrate that high-dose acyclovir is safe to use in young infants.”

Levels of elevated creatine, neutropenia, leukopenia, and thrombocytopenia were measured to assess laboratory AEs, with benchmarks set by the investigators for what defined an adverse event (AE) and a serious AE for each outcome measure. For elevated creatine, greater than 1.7 mg/dL was considered an AE and greater than 3.0 mg/dL was considered a serious AE; for neutropenia, an AE was less than 5,000/mm³ and a serious AE was less than 100/mm³; for leukopenia, less than 5,000/mm³ was an AE and less than 2,000/mm³ was a serious AE; and for thrombocytopenia, less than 100,000/mm³ was considered an AE and less than 20,000/mm³ was considered serious.

Clinical AEs were found in 31% of the 359 infants who received a 20 mg/kg per dose every 8 hours, the most common of which were hypotension (16%) and seizure (11%).

Laboratory AEs were less prevalent: 5% had a creatine AE, and 1% had a serious creatine AE; 3% had a neutropenia AE, and 0.3% had a serious neutropenia AE; 12% had a leukopenia AE, and 0.6% had a serious leukopenia AE; and 19% had a thrombocytopenia AE, while 5% had a serious thrombocytopenia AE.

A total of 38 infants (11%) died; no renal failure requiring dialysis was reported.

Previous studies had noted that renal toxicity and thrombocytopenia were expected AEs, Dr. Ericson said. All infants were discharged from a neonatal intensive care unit managed by the Pediatrix Medical Group, and were exposed to acyclovir for no fewer than 14 days specifically for the treatment of HSV infections. All infants were treated for fewer than 120 days, and all data came from the years 2002–2012. Median birth weight was 2,191 g, and median gestational age was 34 weeks.

Regarding limitations to the study, Dr. Ericson explained that there was no control group cohort because “as high-dose acyclovir is used for at least 14 days, typically only with evidence of HSV disease, there is no obvious control group to use for comparison.” Additionally, lab collection was conducted at the discretion of the treating physician, as this wasn’t a standard trial protocol.

Because this trial wasn’t a observational study, Dr. Ericson explained, it’s possible that some of the laboratory events were due to the underlying HSV disease and not the exposure to acyclovir. However, because serious AEs were rare, Dr. Ericson concluded by saying that the high-dose acyclovir should be the preferred treatment option “when neonatal HSV disease is suspected.”

Dr. Ericson did not report any relevant financial disclosures.

[email protected]

SAN DIEGO – Prophylactic indomethacin does not have any association with reducing the risk of bronchopulmonary dysplasia (BPD) or death in infants born extremely premature, according to an observational study presented by Dr. Erik Jensen, a neonatologist at the Children’s Hospital of Philadelphia, at the annual meeting of the Pediatric Academic Societies.

“Observational studies consistently show that patent ductus arteriosus [PDA] is a strong risk factor for [BPD] in very preterm infants [but] it remains uncertain whether PDA is a cause, or simply a marker, of increased BPD risk,” said Dr. Jensen. “Data from randomized trials indicate that prophylactic indomethacin reduces the risk of subsequent symptomatic PDA, yet there is no evidence from these studies that prophylactic indomethacin reduces BPD.”

© Fuse/Thinkstock

Infants in the study who received prophylactic indomethacin experienced BPD at a rate of 44%, the exact same as those who did not receive prophylactic indomethacin. The rates of death before 36 weeks postmenstrual age also were not significantly different: 17% in infants receiving prophylactic indomethacin vs. 13% in infants who did not. Death or BPD occurred in 54% of prophylactic indomethacin subjects, and in 51% of infants who did not receive prophylactic indomethacin. An infant was defined as having BPD if they received supplemental oxygen at 36 weeks postmenstrual age.

All subjects in the study were enrolled in the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s Neonatal Research Network generic database between 2008 and 2012, and were less than 29 weeks’ gestational age. The mean age of infants who received prophylactic indomethacin was 25.9 weeks, and the mean age was 26.7 weeks for infants who did not (P < .001). Mean body weight was 777 g for those who received prophylactic indomethacin vs. 912 g for those who did not (P < .001). Males made up 49% of the prophylactic indomethacin cohort and 52% of the other cohort (P < .006).

In total, 8,039 infants were included in the study, with 2,671 receiving prophylactic indomethacin and 5,368 infants who did not receive the drug; of those, commencement of PDA treatment was variable from center to center. PDA treatment after day 1 occurred in 21% of infants who received prophylactic indomethacin, and in 36% of those who did not (P < .001).

Dr. Jensen did not report any relevant financial disclosures.

[email protected]

SAN DIEGO – Prophylactic indomethacin does not have any association with reducing the risk of bronchopulmonary dysplasia (BPD) or death in infants born extremely premature, according to an observational study presented by Dr. Erik Jensen, a neonatologist at the Children’s Hospital of Philadelphia, at the annual meeting of the Pediatric Academic Societies.

“Observational studies consistently show that patent ductus arteriosus [PDA] is a strong risk factor for [BPD] in very preterm infants [but] it remains uncertain whether PDA is a cause, or simply a marker, of increased BPD risk,” said Dr. Jensen. “Data from randomized trials indicate that prophylactic indomethacin reduces the risk of subsequent symptomatic PDA, yet there is no evidence from these studies that prophylactic indomethacin reduces BPD.”

© Fuse/Thinkstock

Infants in the study who received prophylactic indomethacin experienced BPD at a rate of 44%, the exact same as those who did not receive prophylactic indomethacin. The rates of death before 36 weeks postmenstrual age also were not significantly different: 17% in infants receiving prophylactic indomethacin vs. 13% in infants who did not. Death or BPD occurred in 54% of prophylactic indomethacin subjects, and in 51% of infants who did not receive prophylactic indomethacin. An infant was defined as having BPD if they received supplemental oxygen at 36 weeks postmenstrual age.

All subjects in the study were enrolled in the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s Neonatal Research Network generic database between 2008 and 2012, and were less than 29 weeks’ gestational age. The mean age of infants who received prophylactic indomethacin was 25.9 weeks, and the mean age was 26.7 weeks for infants who did not (P < .001). Mean body weight was 777 g for those who received prophylactic indomethacin vs. 912 g for those who did not (P < .001). Males made up 49% of the prophylactic indomethacin cohort and 52% of the other cohort (P < .006).

In total, 8,039 infants were included in the study, with 2,671 receiving prophylactic indomethacin and 5,368 infants who did not receive the drug; of those, commencement of PDA treatment was variable from center to center. PDA treatment after day 1 occurred in 21% of infants who received prophylactic indomethacin, and in 36% of those who did not (P < .001).

Dr. Jensen did not report any relevant financial disclosures.

[email protected]

SAN DIEGO – Prophylactic indomethacin does not have any association with reducing the risk of bronchopulmonary dysplasia (BPD) or death in infants born extremely premature, according to an observational study presented by Dr. Erik Jensen, a neonatologist at the Children’s Hospital of Philadelphia, at the annual meeting of the Pediatric Academic Societies.

“Observational studies consistently show that patent ductus arteriosus [PDA] is a strong risk factor for [BPD] in very preterm infants [but] it remains uncertain whether PDA is a cause, or simply a marker, of increased BPD risk,” said Dr. Jensen. “Data from randomized trials indicate that prophylactic indomethacin reduces the risk of subsequent symptomatic PDA, yet there is no evidence from these studies that prophylactic indomethacin reduces BPD.”

© Fuse/Thinkstock

Infants in the study who received prophylactic indomethacin experienced BPD at a rate of 44%, the exact same as those who did not receive prophylactic indomethacin. The rates of death before 36 weeks postmenstrual age also were not significantly different: 17% in infants receiving prophylactic indomethacin vs. 13% in infants who did not. Death or BPD occurred in 54% of prophylactic indomethacin subjects, and in 51% of infants who did not receive prophylactic indomethacin. An infant was defined as having BPD if they received supplemental oxygen at 36 weeks postmenstrual age.

All subjects in the study were enrolled in the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s Neonatal Research Network generic database between 2008 and 2012, and were less than 29 weeks’ gestational age. The mean age of infants who received prophylactic indomethacin was 25.9 weeks, and the mean age was 26.7 weeks for infants who did not (P < .001). Mean body weight was 777 g for those who received prophylactic indomethacin vs. 912 g for those who did not (P < .001). Males made up 49% of the prophylactic indomethacin cohort and 52% of the other cohort (P < .006).

In total, 8,039 infants were included in the study, with 2,671 receiving prophylactic indomethacin and 5,368 infants who did not receive the drug; of those, commencement of PDA treatment was variable from center to center. PDA treatment after day 1 occurred in 21% of infants who received prophylactic indomethacin, and in 36% of those who did not (P < .001).

Dr. Jensen did not report any relevant financial disclosures.

[email protected]

SAN DIEGO – Gestational age and postnatal age dependent intestinal barrier maturation in preterm infants may be altered by feeding and antibiotic exposures, a study conducted at two centers showed.

Mature, healthy intestinal mucosa is lined by a monolayer of epithelial cells that forms tight junctions and acts as a selective barrier to bacteria and harmful toxins, Dr. Rose M. Viscardi said at the annual meeting of the Pediatric Academic Societies. Intestinal permeability (IP) defines the leakiness of the mucosal barrier, and previous studies suggest that preterm infants have increased IP at birth that matures over time.

According to Dr. Viscardi, professor of pediatrics at the University of Maryland, Baltimore, increased IP is a risk factor for necrotizing enterocolitis (NEC). IP is disturbed in the newborn, particularly in preterm infants, “because they’re exposed to antibiotics and often delivered by cesarean section,” she said. “This may alter the IP such that there is the potential for bacteria crossing through that paracellular pathway, leading to enhanced neutrophil recruitment and intense inflammatory response both locally in the intestines as well as systematically, leading to the development of NEC.”

Current methods of determining intestinal barrier function include measurements of lactulose (La) and rhamnose (Rh) in urine and plasma, as well as stool alpha 1 antitrypsin (A1AT), a 52-KD glycoprotein produced by the liver, intestinal macrophages, and mucous membrane cells. Dr. Viscardi and her associates set out to determine changes in IP measures by urinary La/Rh and stool A1AT in the first 2 weeks of life in neonates at 24-32 weeks gestational age. The secondary objective was to determine the effect of feeding practices and antibiotic exposure on the IP maturation process in the first 2 weeks of life in those same infants.

At two sites, the researchers enrolled 43 infants at 24-32 weeks gestational age who received 1 mL/kg La/Rh solution (8.6 g La plus 140 mg Rh/100 mL sterile water) administered enterally on study days 1, 8, and 15, with urine collected after 4 hours. The researchers collected .5 mL blood by heel stick 90-120 minutes post La/Rh for serum La/Rh, and stool within 8 hours of La/Rh dose for fecal A1AT and later microbiome analysis.

Of the 43 subjects, 23 (53%) were male, 23 (53%) were African American, their mean gestational age was 30 weeks, and their mean birth weight was 1,336 g. A total of 38 subjects completed measurements at baseline, on day 8, and on day 15. Dr. Viscardi and her associates found that the La/Rh ratio decreased between day 1 and day 8 in 97% of subjects, but increased greater than .048 between day 8 and day 15 in 21% of subjects.

In addition, exclusively breast milk–fed infants were less likely than were formula-fed (with or without breast milk) infants to experience an increase in IP between day 8 and day 15 (11% vs. 50%, respectively; P =. 019). They also observed a trend toward the use of ceftriaxone and increased IP between day 8 and day 15 (50% vs. 16%; P = .094). No subject developed NEC of stage 2 or higher.

“The data demonstrate that the preterm intestine is ‘leaky’ at birth and barrier function improves over time in a gestational and postnatal age-dependent manner,” Dr. Viscardi concluded. “Exclusive breast milk feeding may prevent increases in IP related to the introduction of oral feeding.”

The National Center for Complementary and Alternative Medicine and the Gerber Foundation funded the study. Dr. Viscardi reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Gestational age and postnatal age dependent intestinal barrier maturation in preterm infants may be altered by feeding and antibiotic exposures, a study conducted at two centers showed.

Mature, healthy intestinal mucosa is lined by a monolayer of epithelial cells that forms tight junctions and acts as a selective barrier to bacteria and harmful toxins, Dr. Rose M. Viscardi said at the annual meeting of the Pediatric Academic Societies. Intestinal permeability (IP) defines the leakiness of the mucosal barrier, and previous studies suggest that preterm infants have increased IP at birth that matures over time.

According to Dr. Viscardi, professor of pediatrics at the University of Maryland, Baltimore, increased IP is a risk factor for necrotizing enterocolitis (NEC). IP is disturbed in the newborn, particularly in preterm infants, “because they’re exposed to antibiotics and often delivered by cesarean section,” she said. “This may alter the IP such that there is the potential for bacteria crossing through that paracellular pathway, leading to enhanced neutrophil recruitment and intense inflammatory response both locally in the intestines as well as systematically, leading to the development of NEC.”

Current methods of determining intestinal barrier function include measurements of lactulose (La) and rhamnose (Rh) in urine and plasma, as well as stool alpha 1 antitrypsin (A1AT), a 52-KD glycoprotein produced by the liver, intestinal macrophages, and mucous membrane cells. Dr. Viscardi and her associates set out to determine changes in IP measures by urinary La/Rh and stool A1AT in the first 2 weeks of life in neonates at 24-32 weeks gestational age. The secondary objective was to determine the effect of feeding practices and antibiotic exposure on the IP maturation process in the first 2 weeks of life in those same infants.

At two sites, the researchers enrolled 43 infants at 24-32 weeks gestational age who received 1 mL/kg La/Rh solution (8.6 g La plus 140 mg Rh/100 mL sterile water) administered enterally on study days 1, 8, and 15, with urine collected after 4 hours. The researchers collected .5 mL blood by heel stick 90-120 minutes post La/Rh for serum La/Rh, and stool within 8 hours of La/Rh dose for fecal A1AT and later microbiome analysis.

Of the 43 subjects, 23 (53%) were male, 23 (53%) were African American, their mean gestational age was 30 weeks, and their mean birth weight was 1,336 g. A total of 38 subjects completed measurements at baseline, on day 8, and on day 15. Dr. Viscardi and her associates found that the La/Rh ratio decreased between day 1 and day 8 in 97% of subjects, but increased greater than .048 between day 8 and day 15 in 21% of subjects.

In addition, exclusively breast milk–fed infants were less likely than were formula-fed (with or without breast milk) infants to experience an increase in IP between day 8 and day 15 (11% vs. 50%, respectively; P =. 019). They also observed a trend toward the use of ceftriaxone and increased IP between day 8 and day 15 (50% vs. 16%; P = .094). No subject developed NEC of stage 2 or higher.

“The data demonstrate that the preterm intestine is ‘leaky’ at birth and barrier function improves over time in a gestational and postnatal age-dependent manner,” Dr. Viscardi concluded. “Exclusive breast milk feeding may prevent increases in IP related to the introduction of oral feeding.”

The National Center for Complementary and Alternative Medicine and the Gerber Foundation funded the study. Dr. Viscardi reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Gestational age and postnatal age dependent intestinal barrier maturation in preterm infants may be altered by feeding and antibiotic exposures, a study conducted at two centers showed.

Mature, healthy intestinal mucosa is lined by a monolayer of epithelial cells that forms tight junctions and acts as a selective barrier to bacteria and harmful toxins, Dr. Rose M. Viscardi said at the annual meeting of the Pediatric Academic Societies. Intestinal permeability (IP) defines the leakiness of the mucosal barrier, and previous studies suggest that preterm infants have increased IP at birth that matures over time.

According to Dr. Viscardi, professor of pediatrics at the University of Maryland, Baltimore, increased IP is a risk factor for necrotizing enterocolitis (NEC). IP is disturbed in the newborn, particularly in preterm infants, “because they’re exposed to antibiotics and often delivered by cesarean section,” she said. “This may alter the IP such that there is the potential for bacteria crossing through that paracellular pathway, leading to enhanced neutrophil recruitment and intense inflammatory response both locally in the intestines as well as systematically, leading to the development of NEC.”

Current methods of determining intestinal barrier function include measurements of lactulose (La) and rhamnose (Rh) in urine and plasma, as well as stool alpha 1 antitrypsin (A1AT), a 52-KD glycoprotein produced by the liver, intestinal macrophages, and mucous membrane cells. Dr. Viscardi and her associates set out to determine changes in IP measures by urinary La/Rh and stool A1AT in the first 2 weeks of life in neonates at 24-32 weeks gestational age. The secondary objective was to determine the effect of feeding practices and antibiotic exposure on the IP maturation process in the first 2 weeks of life in those same infants.

At two sites, the researchers enrolled 43 infants at 24-32 weeks gestational age who received 1 mL/kg La/Rh solution (8.6 g La plus 140 mg Rh/100 mL sterile water) administered enterally on study days 1, 8, and 15, with urine collected after 4 hours. The researchers collected .5 mL blood by heel stick 90-120 minutes post La/Rh for serum La/Rh, and stool within 8 hours of La/Rh dose for fecal A1AT and later microbiome analysis.

Of the 43 subjects, 23 (53%) were male, 23 (53%) were African American, their mean gestational age was 30 weeks, and their mean birth weight was 1,336 g. A total of 38 subjects completed measurements at baseline, on day 8, and on day 15. Dr. Viscardi and her associates found that the La/Rh ratio decreased between day 1 and day 8 in 97% of subjects, but increased greater than .048 between day 8 and day 15 in 21% of subjects.

In addition, exclusively breast milk–fed infants were less likely than were formula-fed (with or without breast milk) infants to experience an increase in IP between day 8 and day 15 (11% vs. 50%, respectively; P =. 019). They also observed a trend toward the use of ceftriaxone and increased IP between day 8 and day 15 (50% vs. 16%; P = .094). No subject developed NEC of stage 2 or higher.

“The data demonstrate that the preterm intestine is ‘leaky’ at birth and barrier function improves over time in a gestational and postnatal age-dependent manner,” Dr. Viscardi concluded. “Exclusive breast milk feeding may prevent increases in IP related to the introduction of oral feeding.”

The National Center for Complementary and Alternative Medicine and the Gerber Foundation funded the study. Dr. Viscardi reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Hospitals treating neurologically impaired children with pneumonia typically have the best clinical outcomes, shortest lengths of stay, and lowest readmission rates when fewer diagnostic tests are performed.

This suggests that testing protocols across hospital centers should be standardized so clinicians perform as few testing procedures as possible, thus ensuring an elevated standard of care, said Dr. Joanna E. Thomson, a pediatric hospitalist at the Cincinnati Children’s Hospital Medical Center.

“This population of children accounts for an increasing and disproportionate amount of inpatient hospital resources,” Dr. Thomson said at the annual meeting of the Pediatric Academic Societies. “While they represent just 14% of pediatric admissions, they account for 25% of pediatric hospital days and 30% of pediatric hospital charges.”

As defined by Dr. Thomson and her coinvestigators, neurological impairment (NI) was defined as any “neurologic disease resulting in functional or intellectual impairment,” such as cerebral palsy or epilepsy. Within the population of children with NI, pneumonia is a common reason for intensive care unit admission and the most common cause of death, but diagnostic testing, treatment, and outcomes vary widely from center to center.

After reviewing data on all children aged 1-18 years admitted to one of 40 U.S. children’s hospitals in the Pediatric Health Information Systems (PHIS) database for pneumonia from 2007 to 2012, Dr. Thomson and her associates selected 28,123 subjects for inclusion in the retrospective cohort study. The study had two primary outcomes: assess the variability of diagnostic testing performed at each center and determine the association of hospital-level diagnostic test utilization and hospitalization outcomes, mainly length of stay and 30-day readmission rates.

K-mean clustering was used to divide each hospital center into one of three groups – A, B, or C – based on diagnostic testing habits, with the proportion of patients receiving such testing compared across all included centers. Diagnostic testing was defined as laboratory studies and radiologic imaging ordered within the first 48 hours of admission. Kruskal-Wallis tests were used to compare the outcomes at each hospital.

Hospital centers in group C tended to perform significantly fewer tests than those in groups A and B, Dr. Thomson said.

Complete blood counts were performed on 56% of patients in group C centers, compared with 78% in group A and 72% in group B. Similarly, C-reactive protein tests were administered to 17% of patients in group A, 34% in group B, and 15% in group C. Viral studies were done on 24% of patients in group C, but 44% in group A and 52% in group B. Blood cultures were taken from 44% of patients in group C, but 63% in group A and 66% in group B. Urine culture tests were performed for 9% in group C, 22% of patients in group A, and 17% in group B, she reported.

The only test measured for which group C was not the lowest was respiratory culture: group C centers tested 5% of patients, while those in group A tested 15% and group B only tested 3% of patients.

Length of stay and 30-day readmission rates also were consistently lower for group C than groups A and B. Median length of stay across groups was 3.2 days; no hospital center in group C had a mean length of stay higher than 3.2, compared with 14 centers in group A and 5 in group B. The median 30-day readmission rate was 7.9% across all groups, a rate exceeded by 11 group A centers, 6 group B centers, and only 2 group C centers.

“We found [that] substantial hospital level variation exists in both diagnostic testing and outcomes,” Dr. Thomson said, adding that, since centers performing the fewest tests yielded the best outcomes, the findings here “represent an opportunity to improve the value of care provided to this important pediatric population” and that “overall testing can likely decrease without compromising the care we provide.”

Dr. Thomson did not report any relevant financial disclosures.

[email protected]

SAN DIEGO – Hospitals treating neurologically impaired children with pneumonia typically have the best clinical outcomes, shortest lengths of stay, and lowest readmission rates when fewer diagnostic tests are performed.

This suggests that testing protocols across hospital centers should be standardized so clinicians perform as few testing procedures as possible, thus ensuring an elevated standard of care, said Dr. Joanna E. Thomson, a pediatric hospitalist at the Cincinnati Children’s Hospital Medical Center.

“This population of children accounts for an increasing and disproportionate amount of inpatient hospital resources,” Dr. Thomson said at the annual meeting of the Pediatric Academic Societies. “While they represent just 14% of pediatric admissions, they account for 25% of pediatric hospital days and 30% of pediatric hospital charges.”

As defined by Dr. Thomson and her coinvestigators, neurological impairment (NI) was defined as any “neurologic disease resulting in functional or intellectual impairment,” such as cerebral palsy or epilepsy. Within the population of children with NI, pneumonia is a common reason for intensive care unit admission and the most common cause of death, but diagnostic testing, treatment, and outcomes vary widely from center to center.

After reviewing data on all children aged 1-18 years admitted to one of 40 U.S. children’s hospitals in the Pediatric Health Information Systems (PHIS) database for pneumonia from 2007 to 2012, Dr. Thomson and her associates selected 28,123 subjects for inclusion in the retrospective cohort study. The study had two primary outcomes: assess the variability of diagnostic testing performed at each center and determine the association of hospital-level diagnostic test utilization and hospitalization outcomes, mainly length of stay and 30-day readmission rates.

K-mean clustering was used to divide each hospital center into one of three groups – A, B, or C – based on diagnostic testing habits, with the proportion of patients receiving such testing compared across all included centers. Diagnostic testing was defined as laboratory studies and radiologic imaging ordered within the first 48 hours of admission. Kruskal-Wallis tests were used to compare the outcomes at each hospital.

Hospital centers in group C tended to perform significantly fewer tests than those in groups A and B, Dr. Thomson said.

Complete blood counts were performed on 56% of patients in group C centers, compared with 78% in group A and 72% in group B. Similarly, C-reactive protein tests were administered to 17% of patients in group A, 34% in group B, and 15% in group C. Viral studies were done on 24% of patients in group C, but 44% in group A and 52% in group B. Blood cultures were taken from 44% of patients in group C, but 63% in group A and 66% in group B. Urine culture tests were performed for 9% in group C, 22% of patients in group A, and 17% in group B, she reported.

The only test measured for which group C was not the lowest was respiratory culture: group C centers tested 5% of patients, while those in group A tested 15% and group B only tested 3% of patients.

Length of stay and 30-day readmission rates also were consistently lower for group C than groups A and B. Median length of stay across groups was 3.2 days; no hospital center in group C had a mean length of stay higher than 3.2, compared with 14 centers in group A and 5 in group B. The median 30-day readmission rate was 7.9% across all groups, a rate exceeded by 11 group A centers, 6 group B centers, and only 2 group C centers.

“We found [that] substantial hospital level variation exists in both diagnostic testing and outcomes,” Dr. Thomson said, adding that, since centers performing the fewest tests yielded the best outcomes, the findings here “represent an opportunity to improve the value of care provided to this important pediatric population” and that “overall testing can likely decrease without compromising the care we provide.”

Dr. Thomson did not report any relevant financial disclosures.

[email protected]

SAN DIEGO – Hospitals treating neurologically impaired children with pneumonia typically have the best clinical outcomes, shortest lengths of stay, and lowest readmission rates when fewer diagnostic tests are performed.

This suggests that testing protocols across hospital centers should be standardized so clinicians perform as few testing procedures as possible, thus ensuring an elevated standard of care, said Dr. Joanna E. Thomson, a pediatric hospitalist at the Cincinnati Children’s Hospital Medical Center.

“This population of children accounts for an increasing and disproportionate amount of inpatient hospital resources,” Dr. Thomson said at the annual meeting of the Pediatric Academic Societies. “While they represent just 14% of pediatric admissions, they account for 25% of pediatric hospital days and 30% of pediatric hospital charges.”

As defined by Dr. Thomson and her coinvestigators, neurological impairment (NI) was defined as any “neurologic disease resulting in functional or intellectual impairment,” such as cerebral palsy or epilepsy. Within the population of children with NI, pneumonia is a common reason for intensive care unit admission and the most common cause of death, but diagnostic testing, treatment, and outcomes vary widely from center to center.

After reviewing data on all children aged 1-18 years admitted to one of 40 U.S. children’s hospitals in the Pediatric Health Information Systems (PHIS) database for pneumonia from 2007 to 2012, Dr. Thomson and her associates selected 28,123 subjects for inclusion in the retrospective cohort study. The study had two primary outcomes: assess the variability of diagnostic testing performed at each center and determine the association of hospital-level diagnostic test utilization and hospitalization outcomes, mainly length of stay and 30-day readmission rates.

K-mean clustering was used to divide each hospital center into one of three groups – A, B, or C – based on diagnostic testing habits, with the proportion of patients receiving such testing compared across all included centers. Diagnostic testing was defined as laboratory studies and radiologic imaging ordered within the first 48 hours of admission. Kruskal-Wallis tests were used to compare the outcomes at each hospital.

Hospital centers in group C tended to perform significantly fewer tests than those in groups A and B, Dr. Thomson said.

Complete blood counts were performed on 56% of patients in group C centers, compared with 78% in group A and 72% in group B. Similarly, C-reactive protein tests were administered to 17% of patients in group A, 34% in group B, and 15% in group C. Viral studies were done on 24% of patients in group C, but 44% in group A and 52% in group B. Blood cultures were taken from 44% of patients in group C, but 63% in group A and 66% in group B. Urine culture tests were performed for 9% in group C, 22% of patients in group A, and 17% in group B, she reported.

The only test measured for which group C was not the lowest was respiratory culture: group C centers tested 5% of patients, while those in group A tested 15% and group B only tested 3% of patients.

Length of stay and 30-day readmission rates also were consistently lower for group C than groups A and B. Median length of stay across groups was 3.2 days; no hospital center in group C had a mean length of stay higher than 3.2, compared with 14 centers in group A and 5 in group B. The median 30-day readmission rate was 7.9% across all groups, a rate exceeded by 11 group A centers, 6 group B centers, and only 2 group C centers.

“We found [that] substantial hospital level variation exists in both diagnostic testing and outcomes,” Dr. Thomson said, adding that, since centers performing the fewest tests yielded the best outcomes, the findings here “represent an opportunity to improve the value of care provided to this important pediatric population” and that “overall testing can likely decrease without compromising the care we provide.”

Dr. Thomson did not report any relevant financial disclosures.

[email protected]

SAN DIEGO – Teens with chronic illnesses who participated in a program that consisted of mind-body principles and peer support demonstrated statistically significant positive changes in physical and mental well-being, anger, tension, and stress, in a pilot study.

“Young people living with serious chronic illnesses must deal not only with the physical effects and uncomfortable symptoms of their conditions, but must also endure significant psychosocial effects,” Dr. Brittany Blockman said in an interview in advance of the annual meeting of the Pediatric Academic Societies. “As we learn more about the impact of stress not only on mental health but also physical health, it will be important to design interventions and programs that address this vital, yet sometimes intangible area of health.”

Mind-body medicine focuses on the ways in which emotional, mental, social, and spiritual factors can directly impact health, said Dr. Blockman, a resident physician for the University of California, San Francisco’s Pediatric Leadership for the Underserved program. “Mind-body skills can enhance an individual’s sense of control and have been demonstrated to lower sympathetic arousal, decrease anxiety, and improve mood. Some examples of these modalities include meditation, mindfulness practices, breath work, yoga, biofeedback, and guided imagery. There is a growing body of literature reporting the positive physical and psychological health benefits of mind-body group interventions in various adult populations living with chronic illnesses, including improvements in quality of life, mood, pain, stress, coping skills, disease progression, and mortality. However, there is limited research exploring similar mind-body and group support interventions in pediatric and adolescent populations.”

Dr. Blockman and her associates enrolled 10 teens aged 13-18 years with chronic illnesses, and their parents, to study the impact of Communitas, a novel program that provides mind-body skills and peer support. Teens and parents met in separate groups 10 times for 2 hours at a time. Each session consisted of meditation, a lesson on guided imagery or some other mind-body technique, an exercise, and group sharing. The National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale, the Profile of Mood States (POMS), the Brief COPE scale, the Mindfulness Attention Awareness Scale (MAAS), the Perceived Stress Scale, and the Resilience Scale were administered before and after the 10 sessions.

The majority of teens (80%) were female; they attended an average of 7.3 sessions. Illnesses represented included juvenile idiopathic arthritis, cerebral palsy, type 1 diabetes, cancer, muscular dystrophy, cystic fibrosis, lung disease, spinal cord injury, and Wegener’s granulomatosis. Of the nine parents who participated, 75% were female; they completed an average of 7.5 sessions.

When Dr. Blockman and her associates compared baseline teen responses with those immediately after the 10-session intervention, they observed statistically significant effects on a number of scales, including the physical well-being subscale of the NIH PROMIS Global Health Scale (a mean increase of 1.56; P = .047); the mental well-being subscale of the NIH PROMIS Global Health Scale (a mean increase of 2.33; P = .025); the anger subscale of the POMS (a mean decrease of .54; P = .039); the tension subscale of the POMS (a mean decrease of .78; P = .006); the distraction/disengagement subscale of the Brief Cope (a mean decrease of .84; P = .035); and the Perceived Stress Scale (a mean decrease of 3.89; P = .005). The results for adults are still being analyzed.

“I was surprised at how willing the adolescents were to participate in the intervention and how engaged they were in the practices that were taught,” Dr. Blockman said. “It is our hope that the results of this study are helpful in thinking about the types of innovative interventions that may be useful in treating, healing, and supporting adolescents living with chronic illness, as well as their family members.”

She acknowledged certain limitations of the study, including the small sample size and the fact that there was no comparison group. “In the future, we plan to test our intervention further in a controlled trial design study, with a larger sample size. Another limitation is we cannot easily evaluate whether our positive results were attributable to the intervention content or the supportive nature of the intervention group. Our qualitative data may help us in teasing this apart.”

Dr. Blockman reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Teens with chronic illnesses who participated in a program that consisted of mind-body principles and peer support demonstrated statistically significant positive changes in physical and mental well-being, anger, tension, and stress, in a pilot study.

“Young people living with serious chronic illnesses must deal not only with the physical effects and uncomfortable symptoms of their conditions, but must also endure significant psychosocial effects,” Dr. Brittany Blockman said in an interview in advance of the annual meeting of the Pediatric Academic Societies. “As we learn more about the impact of stress not only on mental health but also physical health, it will be important to design interventions and programs that address this vital, yet sometimes intangible area of health.”

Mind-body medicine focuses on the ways in which emotional, mental, social, and spiritual factors can directly impact health, said Dr. Blockman, a resident physician for the University of California, San Francisco’s Pediatric Leadership for the Underserved program. “Mind-body skills can enhance an individual’s sense of control and have been demonstrated to lower sympathetic arousal, decrease anxiety, and improve mood. Some examples of these modalities include meditation, mindfulness practices, breath work, yoga, biofeedback, and guided imagery. There is a growing body of literature reporting the positive physical and psychological health benefits of mind-body group interventions in various adult populations living with chronic illnesses, including improvements in quality of life, mood, pain, stress, coping skills, disease progression, and mortality. However, there is limited research exploring similar mind-body and group support interventions in pediatric and adolescent populations.”

Dr. Blockman and her associates enrolled 10 teens aged 13-18 years with chronic illnesses, and their parents, to study the impact of Communitas, a novel program that provides mind-body skills and peer support. Teens and parents met in separate groups 10 times for 2 hours at a time. Each session consisted of meditation, a lesson on guided imagery or some other mind-body technique, an exercise, and group sharing. The National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale, the Profile of Mood States (POMS), the Brief COPE scale, the Mindfulness Attention Awareness Scale (MAAS), the Perceived Stress Scale, and the Resilience Scale were administered before and after the 10 sessions.

The majority of teens (80%) were female; they attended an average of 7.3 sessions. Illnesses represented included juvenile idiopathic arthritis, cerebral palsy, type 1 diabetes, cancer, muscular dystrophy, cystic fibrosis, lung disease, spinal cord injury, and Wegener’s granulomatosis. Of the nine parents who participated, 75% were female; they completed an average of 7.5 sessions.

When Dr. Blockman and her associates compared baseline teen responses with those immediately after the 10-session intervention, they observed statistically significant effects on a number of scales, including the physical well-being subscale of the NIH PROMIS Global Health Scale (a mean increase of 1.56; P = .047); the mental well-being subscale of the NIH PROMIS Global Health Scale (a mean increase of 2.33; P = .025); the anger subscale of the POMS (a mean decrease of .54; P = .039); the tension subscale of the POMS (a mean decrease of .78; P = .006); the distraction/disengagement subscale of the Brief Cope (a mean decrease of .84; P = .035); and the Perceived Stress Scale (a mean decrease of 3.89; P = .005). The results for adults are still being analyzed.

“I was surprised at how willing the adolescents were to participate in the intervention and how engaged they were in the practices that were taught,” Dr. Blockman said. “It is our hope that the results of this study are helpful in thinking about the types of innovative interventions that may be useful in treating, healing, and supporting adolescents living with chronic illness, as well as their family members.”

She acknowledged certain limitations of the study, including the small sample size and the fact that there was no comparison group. “In the future, we plan to test our intervention further in a controlled trial design study, with a larger sample size. Another limitation is we cannot easily evaluate whether our positive results were attributable to the intervention content or the supportive nature of the intervention group. Our qualitative data may help us in teasing this apart.”

Dr. Blockman reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Teens with chronic illnesses who participated in a program that consisted of mind-body principles and peer support demonstrated statistically significant positive changes in physical and mental well-being, anger, tension, and stress, in a pilot study.

“Young people living with serious chronic illnesses must deal not only with the physical effects and uncomfortable symptoms of their conditions, but must also endure significant psychosocial effects,” Dr. Brittany Blockman said in an interview in advance of the annual meeting of the Pediatric Academic Societies. “As we learn more about the impact of stress not only on mental health but also physical health, it will be important to design interventions and programs that address this vital, yet sometimes intangible area of health.”

Mind-body medicine focuses on the ways in which emotional, mental, social, and spiritual factors can directly impact health, said Dr. Blockman, a resident physician for the University of California, San Francisco’s Pediatric Leadership for the Underserved program. “Mind-body skills can enhance an individual’s sense of control and have been demonstrated to lower sympathetic arousal, decrease anxiety, and improve mood. Some examples of these modalities include meditation, mindfulness practices, breath work, yoga, biofeedback, and guided imagery. There is a growing body of literature reporting the positive physical and psychological health benefits of mind-body group interventions in various adult populations living with chronic illnesses, including improvements in quality of life, mood, pain, stress, coping skills, disease progression, and mortality. However, there is limited research exploring similar mind-body and group support interventions in pediatric and adolescent populations.”

Dr. Blockman and her associates enrolled 10 teens aged 13-18 years with chronic illnesses, and their parents, to study the impact of Communitas, a novel program that provides mind-body skills and peer support. Teens and parents met in separate groups 10 times for 2 hours at a time. Each session consisted of meditation, a lesson on guided imagery or some other mind-body technique, an exercise, and group sharing. The National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale, the Profile of Mood States (POMS), the Brief COPE scale, the Mindfulness Attention Awareness Scale (MAAS), the Perceived Stress Scale, and the Resilience Scale were administered before and after the 10 sessions.

The majority of teens (80%) were female; they attended an average of 7.3 sessions. Illnesses represented included juvenile idiopathic arthritis, cerebral palsy, type 1 diabetes, cancer, muscular dystrophy, cystic fibrosis, lung disease, spinal cord injury, and Wegener’s granulomatosis. Of the nine parents who participated, 75% were female; they completed an average of 7.5 sessions.

When Dr. Blockman and her associates compared baseline teen responses with those immediately after the 10-session intervention, they observed statistically significant effects on a number of scales, including the physical well-being subscale of the NIH PROMIS Global Health Scale (a mean increase of 1.56; P = .047); the mental well-being subscale of the NIH PROMIS Global Health Scale (a mean increase of 2.33; P = .025); the anger subscale of the POMS (a mean decrease of .54; P = .039); the tension subscale of the POMS (a mean decrease of .78; P = .006); the distraction/disengagement subscale of the Brief Cope (a mean decrease of .84; P = .035); and the Perceived Stress Scale (a mean decrease of 3.89; P = .005). The results for adults are still being analyzed.

“I was surprised at how willing the adolescents were to participate in the intervention and how engaged they were in the practices that were taught,” Dr. Blockman said. “It is our hope that the results of this study are helpful in thinking about the types of innovative interventions that may be useful in treating, healing, and supporting adolescents living with chronic illness, as well as their family members.”

She acknowledged certain limitations of the study, including the small sample size and the fact that there was no comparison group. “In the future, we plan to test our intervention further in a controlled trial design study, with a larger sample size. Another limitation is we cannot easily evaluate whether our positive results were attributable to the intervention content or the supportive nature of the intervention group. Our qualitative data may help us in teasing this apart.”

Dr. Blockman reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Promising developments in the treatment and perhaps even prevention of cystic fibrosis–related diabetes are on the horizon – and they’re coming none too soon.

This is a field in need of a kick start, Dr. Antoinette Moran said at the annual meeting of the Pediatric Academic Societies.

Bruce Jancin/Frontline Medical News

She cited her recent review of 664 cystic fibrosis patients treated at the University of Minnesota during 2008-2012. Overall mortality in those with cystic fibrosis–related diabetes (CFRD) was unchanged from the high rates seen in a similar review covering 2003-2008, despite adoption of an institutional policy of aggressive screening for diabetes and early initiation of insulin therapy upon diagnosis of CFRD (Am. J. Respir. Crit. Care Med. 2015;191:194-200).

“Certainly screening and early institution of insulin are critical, but we seem to have come up against a wall. Honestly, at the University of Minnesota there is no way that we can be more aggressive than we already are with screening and with insulin. We have done as much as we can. So we need to think of something different to move this to the next stage,” said Dr. Moran, professor of pediatrics and chief of the division of pediatric endocrinology and diabetes at the University of Minnesota, Minneapolis.

She highlighted what she considers two of the most promising novel areas of CFRD research. One involves high-priority studies laying the groundwork for possible initiation of insulin therapy in cystic fibrosis (CF) patients even before they are diagnosed with CFRD, possibly starting in infancy.

The other major event is the anticipated Food and Drug Administration approval of a fixed-dose combination of ivacaftor and lumacaftor, a combined potentiator and corrector of the CF transmembrane conductance regulator (CFTR). Mutations in this chloride conduction channel are the most common cause of CF. Marketing approval for the new combination agent, which has breakthrough drug designation, is believed to be imminent.

“This is absolutely fascinating and a real game changer in the world of CF: the ability to fix CFTR, the abnormal CF chloride channel,” Dr. Moran said. “It’s expected that virtually every CF patient in the country is going to be on these drugs once the combination is approved.”

A large multicenter postmarketing study known as PROSPECT is in place and ready to start once the ivacaftor/lumacaftor combination receives approval. It will capture patients right before they start the agent and then follow them longitudinally. Dr. Moran is principal investigator for the GIFT (Gastrointestinal/Glucose and Insulin Functional Testing) substudy of PROSPECT. This 75-patient study will entail oral glucose tolerance testing with insulin, glucose, and C-peptide levels obtained at baseline and 1, 6, and 12 months.

The rationale for GIFT comes from the fact that CFTR mutations are present in the pancreatic beta cells of CF patients. An earlier five-patient pilot study conducted by Dr. Moran suggested ivacaftor might improve insulin secretion in patients with CF. This observation raises the question: “If we could start the drugs in very young children, might it prevent the development of diabetes? If the basic CFTR defect impacts beta cell function, it suggests this is going to be the way to get around that impasse – that treatment other than insulin will prevent or at least partially treat CFRD,” she said.

Another approach to preventing CFRD is being pursued by her colleague, Dr. Katie Larson Ode, a pediatric diabetologist at the University of Iowa, Iowa City. She showed that abnormal glucose tolerance was already present in 41% of 6- to 9-year-olds with CF, and among that subgroup, 42% developed early-onset CFRD at an average age of 11 years in girls and 12 years in boys, in contrast to the general Minnesota CF population, where the average age of onset of CFRD is age 23 years.

Moreover, the 59% of 6- to 9-year-olds with normal glucose tolerance had impaired insulin secretion. Their insulin secretion on oral glucose tolerance testing was half that of controls without CF.

This raises a question: Were these CF children born with these defects, or do the abnormalities evolve slowly during childhood? Dr. Ode is attempting to find out by performing annual oral glucose tolerance tests starting in infancy at the time of CF diagnosis. She is looking prospectively at the relationships between glucose and insulin levels and exocrine function, growth, inflammation, and pulmonary function, with the subjects’ unaffected siblings serving as controls.

“If those infants and toddlers with CF have abnormal insulin secretion and if it correlates with worse clinical parameters, we’re really going to have to consider whether we should be starting insulin right away in these babies. After all, we don’t wait to start vitamin D in CF infants until they develop rickets. We treat everything else preventively – we may need to think about doing that with insulin,” said Dr. Moran.

In her 664-patient review of the University of Minnesota experience with CF during 2008-2012, overall mortality in those with CFRD was 1.8 per 100 person-years ,compared with 0.5 per 100 person-years in CF patients without diabetes. In patients with mild CF genotypes, the risk of mortality was 20% in those with CFRD compared with 2% without diabetes. In patients with severe genotypes, overall mortality was 12% in those with CFRD, threefold higher than in those without diabetes.

Dr. Moran reported having financial relationships with Novo Nordisk and Vertex, which is developing ivacaftor/lumacaftor.

[email protected]

SAN DIEGO – Promising developments in the treatment and perhaps even prevention of cystic fibrosis–related diabetes are on the horizon – and they’re coming none too soon.

This is a field in need of a kick start, Dr. Antoinette Moran said at the annual meeting of the Pediatric Academic Societies.

Bruce Jancin/Frontline Medical News

She cited her recent review of 664 cystic fibrosis patients treated at the University of Minnesota during 2008-2012. Overall mortality in those with cystic fibrosis–related diabetes (CFRD) was unchanged from the high rates seen in a similar review covering 2003-2008, despite adoption of an institutional policy of aggressive screening for diabetes and early initiation of insulin therapy upon diagnosis of CFRD (Am. J. Respir. Crit. Care Med. 2015;191:194-200).

“Certainly screening and early institution of insulin are critical, but we seem to have come up against a wall. Honestly, at the University of Minnesota there is no way that we can be more aggressive than we already are with screening and with insulin. We have done as much as we can. So we need to think of something different to move this to the next stage,” said Dr. Moran, professor of pediatrics and chief of the division of pediatric endocrinology and diabetes at the University of Minnesota, Minneapolis.

She highlighted what she considers two of the most promising novel areas of CFRD research. One involves high-priority studies laying the groundwork for possible initiation of insulin therapy in cystic fibrosis (CF) patients even before they are diagnosed with CFRD, possibly starting in infancy.

The other major event is the anticipated Food and Drug Administration approval of a fixed-dose combination of ivacaftor and lumacaftor, a combined potentiator and corrector of the CF transmembrane conductance regulator (CFTR). Mutations in this chloride conduction channel are the most common cause of CF. Marketing approval for the new combination agent, which has breakthrough drug designation, is believed to be imminent.

“This is absolutely fascinating and a real game changer in the world of CF: the ability to fix CFTR, the abnormal CF chloride channel,” Dr. Moran said. “It’s expected that virtually every CF patient in the country is going to be on these drugs once the combination is approved.”

A large multicenter postmarketing study known as PROSPECT is in place and ready to start once the ivacaftor/lumacaftor combination receives approval. It will capture patients right before they start the agent and then follow them longitudinally. Dr. Moran is principal investigator for the GIFT (Gastrointestinal/Glucose and Insulin Functional Testing) substudy of PROSPECT. This 75-patient study will entail oral glucose tolerance testing with insulin, glucose, and C-peptide levels obtained at baseline and 1, 6, and 12 months.

The rationale for GIFT comes from the fact that CFTR mutations are present in the pancreatic beta cells of CF patients. An earlier five-patient pilot study conducted by Dr. Moran suggested ivacaftor might improve insulin secretion in patients with CF. This observation raises the question: “If we could start the drugs in very young children, might it prevent the development of diabetes? If the basic CFTR defect impacts beta cell function, it suggests this is going to be the way to get around that impasse – that treatment other than insulin will prevent or at least partially treat CFRD,” she said.

Another approach to preventing CFRD is being pursued by her colleague, Dr. Katie Larson Ode, a pediatric diabetologist at the University of Iowa, Iowa City. She showed that abnormal glucose tolerance was already present in 41% of 6- to 9-year-olds with CF, and among that subgroup, 42% developed early-onset CFRD at an average age of 11 years in girls and 12 years in boys, in contrast to the general Minnesota CF population, where the average age of onset of CFRD is age 23 years.

Moreover, the 59% of 6- to 9-year-olds with normal glucose tolerance had impaired insulin secretion. Their insulin secretion on oral glucose tolerance testing was half that of controls without CF.

This raises a question: Were these CF children born with these defects, or do the abnormalities evolve slowly during childhood? Dr. Ode is attempting to find out by performing annual oral glucose tolerance tests starting in infancy at the time of CF diagnosis. She is looking prospectively at the relationships between glucose and insulin levels and exocrine function, growth, inflammation, and pulmonary function, with the subjects’ unaffected siblings serving as controls.

“If those infants and toddlers with CF have abnormal insulin secretion and if it correlates with worse clinical parameters, we’re really going to have to consider whether we should be starting insulin right away in these babies. After all, we don’t wait to start vitamin D in CF infants until they develop rickets. We treat everything else preventively – we may need to think about doing that with insulin,” said Dr. Moran.

In her 664-patient review of the University of Minnesota experience with CF during 2008-2012, overall mortality in those with CFRD was 1.8 per 100 person-years ,compared with 0.5 per 100 person-years in CF patients without diabetes. In patients with mild CF genotypes, the risk of mortality was 20% in those with CFRD compared with 2% without diabetes. In patients with severe genotypes, overall mortality was 12% in those with CFRD, threefold higher than in those without diabetes.

Dr. Moran reported having financial relationships with Novo Nordisk and Vertex, which is developing ivacaftor/lumacaftor.

[email protected]

SAN DIEGO – Promising developments in the treatment and perhaps even prevention of cystic fibrosis–related diabetes are on the horizon – and they’re coming none too soon.

This is a field in need of a kick start, Dr. Antoinette Moran said at the annual meeting of the Pediatric Academic Societies.

Bruce Jancin/Frontline Medical News

She cited her recent review of 664 cystic fibrosis patients treated at the University of Minnesota during 2008-2012. Overall mortality in those with cystic fibrosis–related diabetes (CFRD) was unchanged from the high rates seen in a similar review covering 2003-2008, despite adoption of an institutional policy of aggressive screening for diabetes and early initiation of insulin therapy upon diagnosis of CFRD (Am. J. Respir. Crit. Care Med. 2015;191:194-200).

“Certainly screening and early institution of insulin are critical, but we seem to have come up against a wall. Honestly, at the University of Minnesota there is no way that we can be more aggressive than we already are with screening and with insulin. We have done as much as we can. So we need to think of something different to move this to the next stage,” said Dr. Moran, professor of pediatrics and chief of the division of pediatric endocrinology and diabetes at the University of Minnesota, Minneapolis.

She highlighted what she considers two of the most promising novel areas of CFRD research. One involves high-priority studies laying the groundwork for possible initiation of insulin therapy in cystic fibrosis (CF) patients even before they are diagnosed with CFRD, possibly starting in infancy.

The other major event is the anticipated Food and Drug Administration approval of a fixed-dose combination of ivacaftor and lumacaftor, a combined potentiator and corrector of the CF transmembrane conductance regulator (CFTR). Mutations in this chloride conduction channel are the most common cause of CF. Marketing approval for the new combination agent, which has breakthrough drug designation, is believed to be imminent.

“This is absolutely fascinating and a real game changer in the world of CF: the ability to fix CFTR, the abnormal CF chloride channel,” Dr. Moran said. “It’s expected that virtually every CF patient in the country is going to be on these drugs once the combination is approved.”

A large multicenter postmarketing study known as PROSPECT is in place and ready to start once the ivacaftor/lumacaftor combination receives approval. It will capture patients right before they start the agent and then follow them longitudinally. Dr. Moran is principal investigator for the GIFT (Gastrointestinal/Glucose and Insulin Functional Testing) substudy of PROSPECT. This 75-patient study will entail oral glucose tolerance testing with insulin, glucose, and C-peptide levels obtained at baseline and 1, 6, and 12 months.

The rationale for GIFT comes from the fact that CFTR mutations are present in the pancreatic beta cells of CF patients. An earlier five-patient pilot study conducted by Dr. Moran suggested ivacaftor might improve insulin secretion in patients with CF. This observation raises the question: “If we could start the drugs in very young children, might it prevent the development of diabetes? If the basic CFTR defect impacts beta cell function, it suggests this is going to be the way to get around that impasse – that treatment other than insulin will prevent or at least partially treat CFRD,” she said.

Another approach to preventing CFRD is being pursued by her colleague, Dr. Katie Larson Ode, a pediatric diabetologist at the University of Iowa, Iowa City. She showed that abnormal glucose tolerance was already present in 41% of 6- to 9-year-olds with CF, and among that subgroup, 42% developed early-onset CFRD at an average age of 11 years in girls and 12 years in boys, in contrast to the general Minnesota CF population, where the average age of onset of CFRD is age 23 years.

Moreover, the 59% of 6- to 9-year-olds with normal glucose tolerance had impaired insulin secretion. Their insulin secretion on oral glucose tolerance testing was half that of controls without CF.

This raises a question: Were these CF children born with these defects, or do the abnormalities evolve slowly during childhood? Dr. Ode is attempting to find out by performing annual oral glucose tolerance tests starting in infancy at the time of CF diagnosis. She is looking prospectively at the relationships between glucose and insulin levels and exocrine function, growth, inflammation, and pulmonary function, with the subjects’ unaffected siblings serving as controls.

“If those infants and toddlers with CF have abnormal insulin secretion and if it correlates with worse clinical parameters, we’re really going to have to consider whether we should be starting insulin right away in these babies. After all, we don’t wait to start vitamin D in CF infants until they develop rickets. We treat everything else preventively – we may need to think about doing that with insulin,” said Dr. Moran.

In her 664-patient review of the University of Minnesota experience with CF during 2008-2012, overall mortality in those with CFRD was 1.8 per 100 person-years ,compared with 0.5 per 100 person-years in CF patients without diabetes. In patients with mild CF genotypes, the risk of mortality was 20% in those with CFRD compared with 2% without diabetes. In patients with severe genotypes, overall mortality was 12% in those with CFRD, threefold higher than in those without diabetes.

Dr. Moran reported having financial relationships with Novo Nordisk and Vertex, which is developing ivacaftor/lumacaftor.

[email protected]

SAN DIEGO – Iron supplementation, especially in pregnancy, improved toddler communication and social behaviors at 18 months in a large Chinese study.

“Iron deficiency in infancy is associated with altered social and emotional development,” Ming Li, Ph.D., said at the annual meeting of the Pediatric Academic Societies. “Some randomized, controlled trials of iron supplementation in infancy show social and emotional benefits.”

In an effort to assess the effects of iron supplementation and maternal iron status on infant communication and social interaction, Dr. Li of Peking University First Hospital in Beijing, China, in collaboration with Dr. Betsy Lozoff and her associates at the University of Michigan, Ann Arbor, used the 23-item Modified Checklist for Autism in Toddlers (M-CHAT) in 993 children in rural China who were part of two linked randomized, controlled trials. Their mothers had been randomized 1:1 to iron (300 mg ferrous sulfate) plus folate (400 micrograms) or placebo plus folate in pregnancy. As infants, they were randomized 1:1 to iron (liquid iron protein succinylate, about 1 mg Fe/kg per day) or placebo from 6 weeks to 9 months. In all, the two trials yielded four groups of prenatal or postnatal iron: placebo/placebo, placebo/iron, iron/placebo, and iron/iron.

The researchers administered the M-CHAT at 18 months to assess behaviors related to communication and social-emotional functioning, including imitation, joint attention, pretend play, and social referencing. The major outcome was the number of M-CHAT items failed. The threshold was two or more failed of the tool’s six most discriminating items or three or more failed of all 23 M-CHAT items. Bivariate correlation was used to consider the relation with maternal iron status.

The mean age of mothers was 25 years, and 78% were primiparous. More than 98% of the infants were born at term; mean birth weight was 3.36 kg. Their weight-for-age Z score was .90 at 9 months, and .53 at 18 months. Anemia, iron deficiency, and iron deficiency anemia declined with prenatal supplementation, but the majority of mothers were still iron deficient at term.

Dr. Li reported that the number of failed M-CHAT items varied depending on iron supplementation group, and was highest for the placebo/placebo group (3.1) and lowest for the iron/iron group (2.8) (P = 0.04 for linear trend). Mother’s iron status at enrollment was not associated with number of failed M-CHAT items, but late pregnancy iron status was. Lower maternal hemoglobin and higher soluble transferrin receptor predicted a higher number of failed M-CHAT items (P= .01 and P= .02, respectively).

Dr. Li emphasized that the study’s randomized, controlled design supports causal inferences. “These are best considered as behaviors [that are impacted], rather than autistic spectrum disorders,” he said. “The results suggest that iron supplementation in pregnancy has more effect than in infancy, but the infancy dose was low (1 mg/kg per day) and the impact on iron status at 9 months was minimal. Still, the combination of iron supplementation in pregnancy and infancy provided the greatest benefit.”

The pregnancy randomized, controlled trial was funded by Vifor Pharma, Ltd. The infancy randomized controlled trial and all iron measures were supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development with the Office of Dietary Supplements. Dr. Li reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Iron supplementation, especially in pregnancy, improved toddler communication and social behaviors at 18 months in a large Chinese study.

“Iron deficiency in infancy is associated with altered social and emotional development,” Ming Li, Ph.D., said at the annual meeting of the Pediatric Academic Societies. “Some randomized, controlled trials of iron supplementation in infancy show social and emotional benefits.”

In an effort to assess the effects of iron supplementation and maternal iron status on infant communication and social interaction, Dr. Li of Peking University First Hospital in Beijing, China, in collaboration with Dr. Betsy Lozoff and her associates at the University of Michigan, Ann Arbor, used the 23-item Modified Checklist for Autism in Toddlers (M-CHAT) in 993 children in rural China who were part of two linked randomized, controlled trials. Their mothers had been randomized 1:1 to iron (300 mg ferrous sulfate) plus folate (400 micrograms) or placebo plus folate in pregnancy. As infants, they were randomized 1:1 to iron (liquid iron protein succinylate, about 1 mg Fe/kg per day) or placebo from 6 weeks to 9 months. In all, the two trials yielded four groups of prenatal or postnatal iron: placebo/placebo, placebo/iron, iron/placebo, and iron/iron.

The researchers administered the M-CHAT at 18 months to assess behaviors related to communication and social-emotional functioning, including imitation, joint attention, pretend play, and social referencing. The major outcome was the number of M-CHAT items failed. The threshold was two or more failed of the tool’s six most discriminating items or three or more failed of all 23 M-CHAT items. Bivariate correlation was used to consider the relation with maternal iron status.

The mean age of mothers was 25 years, and 78% were primiparous. More than 98% of the infants were born at term; mean birth weight was 3.36 kg. Their weight-for-age Z score was .90 at 9 months, and .53 at 18 months. Anemia, iron deficiency, and iron deficiency anemia declined with prenatal supplementation, but the majority of mothers were still iron deficient at term.

Dr. Li reported that the number of failed M-CHAT items varied depending on iron supplementation group, and was highest for the placebo/placebo group (3.1) and lowest for the iron/iron group (2.8) (P = 0.04 for linear trend). Mother’s iron status at enrollment was not associated with number of failed M-CHAT items, but late pregnancy iron status was. Lower maternal hemoglobin and higher soluble transferrin receptor predicted a higher number of failed M-CHAT items (P= .01 and P= .02, respectively).

Dr. Li emphasized that the study’s randomized, controlled design supports causal inferences. “These are best considered as behaviors [that are impacted], rather than autistic spectrum disorders,” he said. “The results suggest that iron supplementation in pregnancy has more effect than in infancy, but the infancy dose was low (1 mg/kg per day) and the impact on iron status at 9 months was minimal. Still, the combination of iron supplementation in pregnancy and infancy provided the greatest benefit.”

The pregnancy randomized, controlled trial was funded by Vifor Pharma, Ltd. The infancy randomized controlled trial and all iron measures were supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development with the Office of Dietary Supplements. Dr. Li reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Iron supplementation, especially in pregnancy, improved toddler communication and social behaviors at 18 months in a large Chinese study.

“Iron deficiency in infancy is associated with altered social and emotional development,” Ming Li, Ph.D., said at the annual meeting of the Pediatric Academic Societies. “Some randomized, controlled trials of iron supplementation in infancy show social and emotional benefits.”

In an effort to assess the effects of iron supplementation and maternal iron status on infant communication and social interaction, Dr. Li of Peking University First Hospital in Beijing, China, in collaboration with Dr. Betsy Lozoff and her associates at the University of Michigan, Ann Arbor, used the 23-item Modified Checklist for Autism in Toddlers (M-CHAT) in 993 children in rural China who were part of two linked randomized, controlled trials. Their mothers had been randomized 1:1 to iron (300 mg ferrous sulfate) plus folate (400 micrograms) or placebo plus folate in pregnancy. As infants, they were randomized 1:1 to iron (liquid iron protein succinylate, about 1 mg Fe/kg per day) or placebo from 6 weeks to 9 months. In all, the two trials yielded four groups of prenatal or postnatal iron: placebo/placebo, placebo/iron, iron/placebo, and iron/iron.

The researchers administered the M-CHAT at 18 months to assess behaviors related to communication and social-emotional functioning, including imitation, joint attention, pretend play, and social referencing. The major outcome was the number of M-CHAT items failed. The threshold was two or more failed of the tool’s six most discriminating items or three or more failed of all 23 M-CHAT items. Bivariate correlation was used to consider the relation with maternal iron status.

The mean age of mothers was 25 years, and 78% were primiparous. More than 98% of the infants were born at term; mean birth weight was 3.36 kg. Their weight-for-age Z score was .90 at 9 months, and .53 at 18 months. Anemia, iron deficiency, and iron deficiency anemia declined with prenatal supplementation, but the majority of mothers were still iron deficient at term.

Dr. Li reported that the number of failed M-CHAT items varied depending on iron supplementation group, and was highest for the placebo/placebo group (3.1) and lowest for the iron/iron group (2.8) (P = 0.04 for linear trend). Mother’s iron status at enrollment was not associated with number of failed M-CHAT items, but late pregnancy iron status was. Lower maternal hemoglobin and higher soluble transferrin receptor predicted a higher number of failed M-CHAT items (P= .01 and P= .02, respectively).

Dr. Li emphasized that the study’s randomized, controlled design supports causal inferences. “These are best considered as behaviors [that are impacted], rather than autistic spectrum disorders,” he said. “The results suggest that iron supplementation in pregnancy has more effect than in infancy, but the infancy dose was low (1 mg/kg per day) and the impact on iron status at 9 months was minimal. Still, the combination of iron supplementation in pregnancy and infancy provided the greatest benefit.”

The pregnancy randomized, controlled trial was funded by Vifor Pharma, Ltd. The infancy randomized controlled trial and all iron measures were supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development with the Office of Dietary Supplements. Dr. Li reported having no relevant financial conflicts.

[email protected]

On Twitter @dougbrunk

SAN DIEGO – Initiation of a process improvement initiative helped to increase health risk screening during adolescent visits, results from a single-center study showed.

It also revealed challenges inherent in teaching residents about adolescent primary care.

“Adolescence is a peak period for risk-taking behaviors and the development of chronic physical and mental health conditions, which is why many professional organizations recommend that teenagers and young adults receive an annual preventive visit to receive counseling and screening around some of these issues,” lead study author Dr. Maya Kumar said at the annual meeting of the Pediatric Academic Societies. “Unfortunately there’s a growing body of evidence to suggest that most adolescents and young adults are not receiving this recommended preventive care.”

With the introduction of the Affordable Care Act, she continued, “we anticipated that more and more low-income youth would be starting to come to us once they were eligible to sign up for insurance and start receiving primary care. That led us to start asking ourselves the question: Do we have an adequate, comprehensive screening process in place to protect these vulnerable youth?”

At the Children’s Hospital Los Angeles Teen Health Center, where Dr. Kumar served as a fellow in adolescent medicine until 2014, the researchers set out to improve annual documented screening rates within 9 months to 90% or greater for each of four process measures chosen based on the American Academy of Pediatrics’ Bright Futures guidelines: health risk behaviors, sexually transmitted infections/HIV laboratory screening, tuberculosis risk assessment, and vaccine review. The Teen Health Center operates three types of clinics: one staffed by attending physicians, one staffed by fellows, and one staffed by residents. The office staff for all clinics includes one registered nurse, two medical assistants, and four administrative support staff.

“We do have an EMR [electronic medical record] although it does have limitations,” said Dr. Kumar. “If we want to give screening questionnaires to our patients, we have to do it on paper, and then the provider has to manually review it separately from the EMR. There is no way to tell from the EMR the last time the patient came in for a preventive visit. The only way you as a provider can know [that] is to manually comb through every visit they’ve had and look to see what was done.

“We also don’t have an automated system to notify patients when it’s time for their next annual preventive visit, and many of our patients don’t have their parents involved, so they’re unlikely to remember on their own, and we don’t have a consistent way to contact them and remind them.”

The baseline period was July 1 through Aug. 31, 2013, while the intervention period was Sept. 1, 2013, through March 31, 2014. At baseline, “we had a lot of room for improvement,” said Dr. Kumar, who is now an attending physician in adolescent medicine at the University of California, San Diego. “We were underscreening our sexually active youth. We were not looking for TB risk factors, and while we were doing well screening for some risk behaviors such as tobacco exposure, we were not doing so well with other behaviors like whether they wore a bicycle helmet or a seat belt.”

During the 9-month intervention period, the researchers conducted three tests of change based on Deming’s Plan-Do-Study-Act (PDSA) cycles, in which the interventions were developed from discussions in weekly faculty fellow meetings, monthly office business meetings, and discussions with rotating trainees. After each of the PDSA cycles, at least 20 charts from the practice were reviewed to track progress in the 30 days following the intervention.

“We identified a number of factors we felt were contributing to inadequate baseline screening rates, [including] office staff workload,” Dr. Kumar said. “Having only one nurse and two medical assistants to staff multiple clinics running at the same time made it impossible for them to participate in the screening process at baseline; we didn’t have a way to schedule an annual well visit; we did not have a formal TB risk assessment tool; we were stuck using paper questionnaires; and we got feedback from residents who told us when they started the rotation that they were unfamiliar with what was involved in adolescent primary care, because so few of them had been exposed to adolescents during their pediatric residencies.”

The researchers approached the clinic’s IT department to ask if changes to the EMR could be made, including a recall system for annual physicals and provider alerts for the last time a patient had preventive screening. “We were told that was not possible at that time,” Dr. Kumar said. “So we had to focus on key drivers that were within our control.”

The first PDSA cycle focused on cuing the providers to ensure that they were reviewing the paper questionnaire about adolescent health screening. “We asked our medical assistants to insert the paper questionnaire sideways into the patient folders to give the providers a visual cue to stop and review the documents during the visit,” she said. The second PDSA cycle consisted of the introduction of a TB risk assessment form and a well-adolescent visit “cheat sheet” that was distributed to pediatric residents in electronic and hard copy forms, while the third PDSA targeted residents more heavily by giving them a 1-hour lecture about adolescent primary care, and sending an e-mail reminder to rotating residents about necessary screening.

In general, there was an increase for all of the process measures from baseline to the end of the study period, but a certain amount of attrition occurred between PDSA cycles 2 and 3. For example, the TB assessment was 19% at baseline, 27% after PDSA cycle 1, 85% after PDSA cycle 2, and 50% after PDSA cycle 3; screening for sexual activity was 81% at baseline, 91% after PDSA cycle 1, 100% after cycle 2, and 95% after cycle 3; while vaccine review was 57% at baseline, 72% after PDSA cycle 1, 100% after cycle 2, and 80% after cycle 3.

“We managed to improve our screening rates overall for almost all of the measures we were looking at,” Dr. Kumar said. “There was a lot of buy-in and support behind this project from the patients, providers, administrators, and office staff. Considering that we were not allowed to make changes to our EMR, we got a lot of bang for our buck.”

The attrition in many of the process measures by PDSA cycle 3 “highlights the fundamental need we have for systemic solutions rather than relying on individuals to change their behavior,” Dr. Kumar said. “The residents responded positively to the interventions that were targeted towards them. Many indicated that their understanding of adolescent preventive care improved. But they also said it was a lot to learn in a 1-month rotation. The only way we’re going to create sustainable change is to focus on system-based solutions.”

She said that staff at Children’s Hospital Los Angeles Teen Health Center are “working to use these results as leverage to expand EMR functionality to include a recall system for annual physicals; to create provider alerts to inform the provider when the patients are due for their next annual screening; and electronic versions of the questionnaires that the patients can complete and have downloaded directly to the EMR,” she said. “We also recognize the importance of improving longitudinal teaching around adolescent health throughout pediatric residency programs, and not just during a 1-month rotation.”

Dr. Kumar reported having no relevant financial conflicts.

[email protected]


On Twitter @dougbrunk

SAN DIEGO – Initiation of a process improvement initiative helped to increase health risk screening during adolescent visits, results from a single-center study showed.

It also revealed challenges inherent in teaching residents about adolescent primary care.

“Adolescence is a peak period for risk-taking behaviors and the development of chronic physical and mental health conditions, which is why many professional organizations recommend that teenagers and young adults receive an annual preventive visit to receive counseling and screening around some of these issues,” lead study author Dr. Maya Kumar said at the annual meeting of the Pediatric Academic Societies. “Unfortunately there’s a growing body of evidence to suggest that most adolescents and young adults are not receiving this recommended preventive care.”

With the introduction of the Affordable Care Act, she continued, “we anticipated that more and more low-income youth would be starting to come to us once they were eligible to sign up for insurance and start receiving primary care. That led us to start asking ourselves the question: Do we have an adequate, comprehensive screening process in place to protect these vulnerable youth?”

At the Children’s Hospital Los Angeles Teen Health Center, where Dr. Kumar served as a fellow in adolescent medicine until 2014, the researchers set out to improve annual documented screening rates within 9 months to 90% or greater for each of four process measures chosen based on the American Academy of Pediatrics’ Bright Futures guidelines: health risk behaviors, sexually transmitted infections/HIV laboratory screening, tuberculosis risk assessment, and vaccine review. The Teen Health Center operates three types of clinics: one staffed by attending physicians, one staffed by fellows, and one staffed by residents. The office staff for all clinics includes one registered nurse, two medical assistants, and four administrative support staff.

“We do have an EMR [electronic medical record] although it does have limitations,” said Dr. Kumar. “If we want to give screening questionnaires to our patients, we have to do it on paper, and then the provider has to manually review it separately from the EMR. There is no way to tell from the EMR the last time the patient came in for a preventive visit. The only way you as a provider can know [that] is to manually comb through every visit they’ve had and look to see what was done.

“We also don’t have an automated system to notify patients when it’s time for their next annual preventive visit, and many of our patients don’t have their parents involved, so they’re unlikely to remember on their own, and we don’t have a consistent way to contact them and remind them.”

The baseline period was July 1 through Aug. 31, 2013, while the intervention period was Sept. 1, 2013, through March 31, 2014. At baseline, “we had a lot of room for improvement,” said Dr. Kumar, who is now an attending physician in adolescent medicine at the University of California, San Diego. “We were underscreening our sexually active youth. We were not looking for TB risk factors, and while we were doing well screening for some risk behaviors such as tobacco exposure, we were not doing so well with other behaviors like whether they wore a bicycle helmet or a seat belt.”

During the 9-month intervention period, the researchers conducted three tests of change based on Deming’s Plan-Do-Study-Act (PDSA) cycles, in which the interventions were developed from discussions in weekly faculty fellow meetings, monthly office business meetings, and discussions with rotating trainees. After each of the PDSA cycles, at least 20 charts from the practice were reviewed to track progress in the 30 days following the intervention.

“We identified a number of factors we felt were contributing to inadequate baseline screening rates, [including] office staff workload,” Dr. Kumar said. “Having only one nurse and two medical assistants to staff multiple clinics running at the same time made it impossible for them to participate in the screening process at baseline; we didn’t have a way to schedule an annual well visit; we did not have a formal TB risk assessment tool; we were stuck using paper questionnaires; and we got feedback from residents who told us when they started the rotation that they were unfamiliar with what was involved in adolescent primary care, because so few of them had been exposed to adolescents during their pediatric residencies.”

The researchers approached the clinic’s IT department to ask if changes to the EMR could be made, including a recall system for annual physicals and provider alerts for the last time a patient had preventive screening. “We were told that was not possible at that time,” Dr. Kumar said. “So we had to focus on key drivers that were within our control.”

The first PDSA cycle focused on cuing the providers to ensure that they were reviewing the paper questionnaire about adolescent health screening. “We asked our medical assistants to insert the paper questionnaire sideways into the patient folders to give the providers a visual cue to stop and review the documents during the visit,” she said. The second PDSA cycle consisted of the introduction of a TB risk assessment form and a well-adolescent visit “cheat sheet” that was distributed to pediatric residents in electronic and hard copy forms, while the third PDSA targeted residents more heavily by giving them a 1-hour lecture about adolescent primary care, and sending an e-mail reminder to rotating residents about necessary screening.

In general, there was an increase for all of the process measures from baseline to the end of the study period, but a certain amount of attrition occurred between PDSA cycles 2 and 3. For example, the TB assessment was 19% at baseline, 27% after PDSA cycle 1, 85% after PDSA cycle 2, and 50% after PDSA cycle 3; screening for sexual activity was 81% at baseline, 91% after PDSA cycle 1, 100% after cycle 2, and 95% after cycle 3; while vaccine review was 57% at baseline, 72% after PDSA cycle 1, 100% after cycle 2, and 80% after cycle 3.

“We managed to improve our screening rates overall for almost all of the measures we were looking at,” Dr. Kumar said. “There was a lot of buy-in and support behind this project from the patients, providers, administrators, and office staff. Considering that we were not allowed to make changes to our EMR, we got a lot of bang for our buck.”

The attrition in many of the process measures by PDSA cycle 3 “highlights the fundamental need we have for systemic solutions rather than relying on individuals to change their behavior,” Dr. Kumar said. “The residents responded positively to the interventions that were targeted towards them. Many indicated that their understanding of adolescent preventive care improved. But they also said it was a lot to learn in a 1-month rotation. The only way we’re going to create sustainable change is to focus on system-based solutions.”

She said that staff at Children’s Hospital Los Angeles Teen Health Center are “working to use these results as leverage to expand EMR functionality to include a recall system for annual physicals; to create provider alerts to inform the provider when the patients are due for their next annual screening; and electronic versions of the questionnaires that the patients can complete and have downloaded directly to the EMR,” she said. “We also recognize the importance of improving longitudinal teaching around adolescent health throughout pediatric residency programs, and not just during a 1-month rotation.”

Dr. Kumar reported having no relevant financial conflicts.

[email protected]


On Twitter @dougbrunk

SAN DIEGO – Initiation of a process improvement initiative helped to increase health risk screening during adolescent visits, results from a single-center study showed.

It also revealed challenges inherent in teaching residents about adolescent primary care.

“Adolescence is a peak period for risk-taking behaviors and the development of chronic physical and mental health conditions, which is why many professional organizations recommend that teenagers and young adults receive an annual preventive visit to receive counseling and screening around some of these issues,” lead study author Dr. Maya Kumar said at the annual meeting of the Pediatric Academic Societies. “Unfortunately there’s a growing body of evidence to suggest that most adolescents and young adults are not receiving this recommended preventive care.”

With the introduction of the Affordable Care Act, she continued, “we anticipated that more and more low-income youth would be starting to come to us once they were eligible to sign up for insurance and start receiving primary care. That led us to start asking ourselves the question: Do we have an adequate, comprehensive screening process in place to protect these vulnerable youth?”

At the Children’s Hospital Los Angeles Teen Health Center, where Dr. Kumar served as a fellow in adolescent medicine until 2014, the researchers set out to improve annual documented screening rates within 9 months to 90% or greater for each of four process measures chosen based on the American Academy of Pediatrics’ Bright Futures guidelines: health risk behaviors, sexually transmitted infections/HIV laboratory screening, tuberculosis risk assessment, and vaccine review. The Teen Health Center operates three types of clinics: one staffed by attending physicians, one staffed by fellows, and one staffed by residents. The office staff for all clinics includes one registered nurse, two medical assistants, and four administrative support staff.

“We do have an EMR [electronic medical record] although it does have limitations,” said Dr. Kumar. “If we want to give screening questionnaires to our patients, we have to do it on paper, and then the provider has to manually review it separately from the EMR. There is no way to tell from the EMR the last time the patient came in for a preventive visit. The only way you as a provider can know [that] is to manually comb through every visit they’ve had and look to see what was done.

“We also don’t have an automated system to notify patients when it’s time for their next annual preventive visit, and many of our patients don’t have their parents involved, so they’re unlikely to remember on their own, and we don’t have a consistent way to contact them and remind them.”

The baseline period was July 1 through Aug. 31, 2013, while the intervention period was Sept. 1, 2013, through March 31, 2014. At baseline, “we had a lot of room for improvement,” said Dr. Kumar, who is now an attending physician in adolescent medicine at the University of California, San Diego. “We were underscreening our sexually active youth. We were not looking for TB risk factors, and while we were doing well screening for some risk behaviors such as tobacco exposure, we were not doing so well with other behaviors like whether they wore a bicycle helmet or a seat belt.”

During the 9-month intervention period, the researchers conducted three tests of change based on Deming’s Plan-Do-Study-Act (PDSA) cycles, in which the interventions were developed from discussions in weekly faculty fellow meetings, monthly office business meetings, and discussions with rotating trainees. After each of the PDSA cycles, at least 20 charts from the practice were reviewed to track progress in the 30 days following the intervention.

“We identified a number of factors we felt were contributing to inadequate baseline screening rates, [including] office staff workload,” Dr. Kumar said. “Having only one nurse and two medical assistants to staff multiple clinics running at the same time made it impossible for them to participate in the screening process at baseline; we didn’t have a way to schedule an annual well visit; we did not have a formal TB risk assessment tool; we were stuck using paper questionnaires; and we got feedback from residents who told us when they started the rotation that they were unfamiliar with what was involved in adolescent primary care, because so few of them had been exposed to adolescents during their pediatric residencies.”

The researchers approached the clinic’s IT department to ask if changes to the EMR could be made, including a recall system for annual physicals and provider alerts for the last time a patient had preventive screening. “We were told that was not possible at that time,” Dr. Kumar said. “So we had to focus on key drivers that were within our control.”

The first PDSA cycle focused on cuing the providers to ensure that they were reviewing the paper questionnaire about adolescent health screening. “We asked our medical assistants to insert the paper questionnaire sideways into the patient folders to give the providers a visual cue to stop and review the documents during the visit,” she said. The second PDSA cycle consisted of the introduction of a TB risk assessment form and a well-adolescent visit “cheat sheet” that was distributed to pediatric residents in electronic and hard copy forms, while the third PDSA targeted residents more heavily by giving them a 1-hour lecture about adolescent primary care, and sending an e-mail reminder to rotating residents about necessary screening.

In general, there was an increase for all of the process measures from baseline to the end of the study period, but a certain amount of attrition occurred between PDSA cycles 2 and 3. For example, the TB assessment was 19% at baseline, 27% after PDSA cycle 1, 85% after PDSA cycle 2, and 50% after PDSA cycle 3; screening for sexual activity was 81% at baseline, 91% after PDSA cycle 1, 100% after cycle 2, and 95% after cycle 3; while vaccine review was 57% at baseline, 72% after PDSA cycle 1, 100% after cycle 2, and 80% after cycle 3.

“We managed to improve our screening rates overall for almost all of the measures we were looking at,” Dr. Kumar said. “There was a lot of buy-in and support behind this project from the patients, providers, administrators, and office staff. Considering that we were not allowed to make changes to our EMR, we got a lot of bang for our buck.”

The attrition in many of the process measures by PDSA cycle 3 “highlights the fundamental need we have for systemic solutions rather than relying on individuals to change their behavior,” Dr. Kumar said. “The residents responded positively to the interventions that were targeted towards them. Many indicated that their understanding of adolescent preventive care improved. But they also said it was a lot to learn in a 1-month rotation. The only way we’re going to create sustainable change is to focus on system-based solutions.”

She said that staff at Children’s Hospital Los Angeles Teen Health Center are “working to use these results as leverage to expand EMR functionality to include a recall system for annual physicals; to create provider alerts to inform the provider when the patients are due for their next annual screening; and electronic versions of the questionnaires that the patients can complete and have downloaded directly to the EMR,” she said. “We also recognize the importance of improving longitudinal teaching around adolescent health throughout pediatric residency programs, and not just during a 1-month rotation.”

Dr. Kumar reported having no relevant financial conflicts.

[email protected]


On Twitter @dougbrunk

SAN DIEGO – Oral antibiotic therapy should be the preferred postdischarge treatment for pediatric patients with complicated pneumonia, as peripherally inserted central catheter (PICC) treatment has higher rates of treatment failure, adverse drug reactions, and related revisits, according to Dr. Samir S. Shah.

“Pneumonia is important because it is costly; in terms of cumulative costs to children’s hospitals, it is the second-most costly condition,” explained Dr. Shah, director of the division of hospital medicine at the Cincinnati Children’s Hospital Medical Center, who presented the findings of this retrospective cohort study at the annual meeting of the Pediatric Academic Societies.

“It is also potentially serious,” Dr. Shah continued. “Up to 15% of children hospitalized with pneumonia may have their course complicated by empyema, [and] even more problematic is that the incidences of complicated pneumonia are increasing.”

Dr. Shah and his coinvestigators examined the records for all children hospitalized between Jan. 1, 2009, and Dec. 31, 2012, with complicated pneumonia at 36 centers from across the United States. The primary outcome was treatment failure. Secondary outcomes were revisits related to the index admission, such as PICC complications, adverse drug reactions, and overall revisits.

The rate of treatment failure was higher in patients receiving PICC: 3.2% vs. 2.6% for those receiving oral antibiotics after discharge. Adverse drug reactions occurred in 3.2% of subjects receiving PICC, compared with only 0.2% of subjects in the oral antibiotics cohorts. Both related and overall revisits were higher in the PICC cohort than in the oral antibiotics cohort, too: 6.1% vs. 3.0% for related revisits, and 17.8% vs. 5.8% for overall revisits (P < .05). Treatment failure occurred in 49 children across both cohorts (2.3%).

Of the 2,123 children deemed eligible and included in the study, 281 were prescribed PICC as postdischarge treatment (13.2%), and the use of PICC overall varied from hospital to hospital; some centers prescribed PICC treatment in as many as 71% of cases, while some never prescribed it. Serum sickness, drug-induced neutropenia, and PICC thrombosis, dislodgment, and fever were the most commonly reported adverse effects across both cohorts. Treatment failure was reported in 49 (2.3%) cases.

“There were some problems with matching,” explained Dr. Shah, who is also professor of pediatrics at the University of Cincinnati. “Because many centers had small numbers of kids discharged with PICC therapy, we could not account for differences across hospitals.”

A review of charts’ ICD-9 codes in the nationwide Pediatric Health Information System (PHIS) and the Pediatric Research in Inpatient Settings (PRIS) Network was used to collect the patient population, and providers at each of the 36 institutions included reviewed medical records to confirm patient eligibility, define treatment groups, determine which antibiotic each patient was discharged with, and verify outcomes.

“This was an observational study, [and] there are limitations that go with that,” said Dr. Shah. “We adjusted for confounding using propensity score matching, but there are unmeasured confounding factors; [however,] because we matched across hospitals, we could better account for confounding by indication at the patient level.”

Dr. Shah did not report any relevant financial disclosures.

[email protected]

SAN DIEGO – Oral antibiotic therapy should be the preferred postdischarge treatment for pediatric patients with complicated pneumonia, as peripherally inserted central catheter (PICC) treatment has higher rates of treatment failure, adverse drug reactions, and related revisits, according to Dr. Samir S. Shah.

“Pneumonia is important because it is costly; in terms of cumulative costs to children’s hospitals, it is the second-most costly condition,” explained Dr. Shah, director of the division of hospital medicine at the Cincinnati Children’s Hospital Medical Center, who presented the findings of this retrospective cohort study at the annual meeting of the Pediatric Academic Societies.

“It is also potentially serious,” Dr. Shah continued. “Up to 15% of children hospitalized with pneumonia may have their course complicated by empyema, [and] even more problematic is that the incidences of complicated pneumonia are increasing.”

Dr. Shah and his coinvestigators examined the records for all children hospitalized between Jan. 1, 2009, and Dec. 31, 2012, with complicated pneumonia at 36 centers from across the United States. The primary outcome was treatment failure. Secondary outcomes were revisits related to the index admission, such as PICC complications, adverse drug reactions, and overall revisits.

The rate of treatment failure was higher in patients receiving PICC: 3.2% vs. 2.6% for those receiving oral antibiotics after discharge. Adverse drug reactions occurred in 3.2% of subjects receiving PICC, compared with only 0.2% of subjects in the oral antibiotics cohorts. Both related and overall revisits were higher in the PICC cohort than in the oral antibiotics cohort, too: 6.1% vs. 3.0% for related revisits, and 17.8% vs. 5.8% for overall revisits (P < .05). Treatment failure occurred in 49 children across both cohorts (2.3%).

Of the 2,123 children deemed eligible and included in the study, 281 were prescribed PICC as postdischarge treatment (13.2%), and the use of PICC overall varied from hospital to hospital; some centers prescribed PICC treatment in as many as 71% of cases, while some never prescribed it. Serum sickness, drug-induced neutropenia, and PICC thrombosis, dislodgment, and fever were the most commonly reported adverse effects across both cohorts. Treatment failure was reported in 49 (2.3%) cases.

“There were some problems with matching,” explained Dr. Shah, who is also professor of pediatrics at the University of Cincinnati. “Because many centers had small numbers of kids discharged with PICC therapy, we could not account for differences across hospitals.”

A review of charts’ ICD-9 codes in the nationwide Pediatric Health Information System (PHIS) and the Pediatric Research in Inpatient Settings (PRIS) Network was used to collect the patient population, and providers at each of the 36 institutions included reviewed medical records to confirm patient eligibility, define treatment groups, determine which antibiotic each patient was discharged with, and verify outcomes.

“This was an observational study, [and] there are limitations that go with that,” said Dr. Shah. “We adjusted for confounding using propensity score matching, but there are unmeasured confounding factors; [however,] because we matched across hospitals, we could better account for confounding by indication at the patient level.”

Dr. Shah did not report any relevant financial disclosures.

[email protected]

SAN DIEGO – Oral antibiotic therapy should be the preferred postdischarge treatment for pediatric patients with complicated pneumonia, as peripherally inserted central catheter (PICC) treatment has higher rates of treatment failure, adverse drug reactions, and related revisits, according to Dr. Samir S. Shah.

“Pneumonia is important because it is costly; in terms of cumulative costs to children’s hospitals, it is the second-most costly condition,” explained Dr. Shah, director of the division of hospital medicine at the Cincinnati Children’s Hospital Medical Center, who presented the findings of this retrospective cohort study at the annual meeting of the Pediatric Academic Societies.

“It is also potentially serious,” Dr. Shah continued. “Up to 15% of children hospitalized with pneumonia may have their course complicated by empyema, [and] even more problematic is that the incidences of complicated pneumonia are increasing.”

Dr. Shah and his coinvestigators examined the records for all children hospitalized between Jan. 1, 2009, and Dec. 31, 2012, with complicated pneumonia at 36 centers from across the United States. The primary outcome was treatment failure. Secondary outcomes were revisits related to the index admission, such as PICC complications, adverse drug reactions, and overall revisits.

The rate of treatment failure was higher in patients receiving PICC: 3.2% vs. 2.6% for those receiving oral antibiotics after discharge. Adverse drug reactions occurred in 3.2% of subjects receiving PICC, compared with only 0.2% of subjects in the oral antibiotics cohorts. Both related and overall revisits were higher in the PICC cohort than in the oral antibiotics cohort, too: 6.1% vs. 3.0% for related revisits, and 17.8% vs. 5.8% for overall revisits (P < .05). Treatment failure occurred in 49 children across both cohorts (2.3%).

Of the 2,123 children deemed eligible and included in the study, 281 were prescribed PICC as postdischarge treatment (13.2%), and the use of PICC overall varied from hospital to hospital; some centers prescribed PICC treatment in as many as 71% of cases, while some never prescribed it. Serum sickness, drug-induced neutropenia, and PICC thrombosis, dislodgment, and fever were the most commonly reported adverse effects across both cohorts. Treatment failure was reported in 49 (2.3%) cases.

“There were some problems with matching,” explained Dr. Shah, who is also professor of pediatrics at the University of Cincinnati. “Because many centers had small numbers of kids discharged with PICC therapy, we could not account for differences across hospitals.”

A review of charts’ ICD-9 codes in the nationwide Pediatric Health Information System (PHIS) and the Pediatric Research in Inpatient Settings (PRIS) Network was used to collect the patient population, and providers at each of the 36 institutions included reviewed medical records to confirm patient eligibility, define treatment groups, determine which antibiotic each patient was discharged with, and verify outcomes.

“This was an observational study, [and] there are limitations that go with that,” said Dr. Shah. “We adjusted for confounding using propensity score matching, but there are unmeasured confounding factors; [however,] because we matched across hospitals, we could better account for confounding by indication at the patient level.”

Dr. Shah did not report any relevant financial disclosures.

[email protected]