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Giving very preterm infants high-dose recombinant human erythropoietin (EPO) at birth does not improve neurodevelopmental outcomes at 2 years, according to a study published in JAMA.
Researchers found no significant differences between infants who received EPO and those who did not when it came to cognitive development, motor development, cerebral palsy, hearing or visual impairment, and anthropometric growth parameters.
Giancarlo Natalucci, MD, of the University of Zurich in Switzerland, and his colleagues conducted this study in 448 preterm infants who were born between 26 weeks’ gestation and 31 weeks 6 days’ gestation.
The subjects’ average gestational age was 29 weeks, and their average birth weight was 1210 g (2.7 lbs).
The infants were randomized to receive high-dose EPO (n=228) or placebo (saline, n=220) intravenously within 3 hours of birth, at 12 to 18 hours, and at 36 to 42 hours after birth.
Neurodevelopmental outcome data were available for 81% of the infants (n=365) at an average age of 23.6 months.
Cognitive development, as assessed with the Mental Development Index (MDI), was not significantly different between the EPO group and the placebo group. In an intent-to-treat analysis, the mean MDI was 93.5 in the EPO group and 94.5 in the placebo group (P=0.056). In the per-protocol analysis, the mean MDI was 93.9 and 94.5, respectively (P=0.70).
The researchers also found no significant differences between the treatment groups for secondary outcomes such as motor development, cerebral palsy, hearing or visual impairment, and anthropometric growth parameters.
The team assessed motor development using the psychomotor development index (PDI). In the intent-to-treat analysis, the mean PDI was 89.5 in the EPO group and 92.1 in the placebo group (P=0.15). In the per-protocol analysis, the mean PDI was 89.2 and 92.8, respectively (P=0.06).
In the intent-to-treat analysis, the incidence of cerebral palsy was 4% in the EPO group and 5% in the placebo group (P>0.99). In the per-protocol analysis, it was 5% for both groups (P=0.41).
In the intent-to-treat analysis, severe hearing impairment occurred in 1 EPO-treated patient and no placebo-treated patients (P>0.99). Severe visual impairment occurred in 2 and 0, respectively (P=0.50). The incidences were the same in the per-protocol analysis.
And there were no significant differences between the treatment groups (per-protocol or intent-to-treat) when it came to growth parameters such as head circumference, weight, or length.
The researchers said these results suggest that EPO may not have a neuroprotective role in very preterm infants, but follow-up is required to assess cognitive and physical problems that may not become evident until later in life. 
Photo by Petr Kratochvil
Giving very preterm infants high-dose recombinant human erythropoietin (EPO) at birth does not improve neurodevelopmental outcomes at 2 years, according to a study published in JAMA.
Researchers found no significant differences between infants who received EPO and those who did not when it came to cognitive development, motor development, cerebral palsy, hearing or visual impairment, and anthropometric growth parameters.
Giancarlo Natalucci, MD, of the University of Zurich in Switzerland, and his colleagues conducted this study in 448 preterm infants who were born between 26 weeks’ gestation and 31 weeks 6 days’ gestation.
The subjects’ average gestational age was 29 weeks, and their average birth weight was 1210 g (2.7 lbs).
The infants were randomized to receive high-dose EPO (n=228) or placebo (saline, n=220) intravenously within 3 hours of birth, at 12 to 18 hours, and at 36 to 42 hours after birth.
Neurodevelopmental outcome data were available for 81% of the infants (n=365) at an average age of 23.6 months.
Cognitive development, as assessed with the Mental Development Index (MDI), was not significantly different between the EPO group and the placebo group. In an intent-to-treat analysis, the mean MDI was 93.5 in the EPO group and 94.5 in the placebo group (P=0.056). In the per-protocol analysis, the mean MDI was 93.9 and 94.5, respectively (P=0.70).
The researchers also found no significant differences between the treatment groups for secondary outcomes such as motor development, cerebral palsy, hearing or visual impairment, and anthropometric growth parameters.
The team assessed motor development using the psychomotor development index (PDI). In the intent-to-treat analysis, the mean PDI was 89.5 in the EPO group and 92.1 in the placebo group (P=0.15). In the per-protocol analysis, the mean PDI was 89.2 and 92.8, respectively (P=0.06).
In the intent-to-treat analysis, the incidence of cerebral palsy was 4% in the EPO group and 5% in the placebo group (P>0.99). In the per-protocol analysis, it was 5% for both groups (P=0.41).
In the intent-to-treat analysis, severe hearing impairment occurred in 1 EPO-treated patient and no placebo-treated patients (P>0.99). Severe visual impairment occurred in 2 and 0, respectively (P=0.50). The incidences were the same in the per-protocol analysis.
And there were no significant differences between the treatment groups (per-protocol or intent-to-treat) when it came to growth parameters such as head circumference, weight, or length.
The researchers said these results suggest that EPO may not have a neuroprotective role in very preterm infants, but follow-up is required to assess cognitive and physical problems that may not become evident until later in life.
Photo by Petr Kratochvil
Giving very preterm infants high-dose recombinant human erythropoietin (EPO) at birth does not improve neurodevelopmental outcomes at 2 years, according to a study published in JAMA.
Researchers found no significant differences between infants who received EPO and those who did not when it came to cognitive development, motor development, cerebral palsy, hearing or visual impairment, and anthropometric growth parameters.
Giancarlo Natalucci, MD, of the University of Zurich in Switzerland, and his colleagues conducted this study in 448 preterm infants who were born between 26 weeks’ gestation and 31 weeks 6 days’ gestation.
The subjects’ average gestational age was 29 weeks, and their average birth weight was 1210 g (2.7 lbs).
The infants were randomized to receive high-dose EPO (n=228) or placebo (saline, n=220) intravenously within 3 hours of birth, at 12 to 18 hours, and at 36 to 42 hours after birth.
Neurodevelopmental outcome data were available for 81% of the infants (n=365) at an average age of 23.6 months.
Cognitive development, as assessed with the Mental Development Index (MDI), was not significantly different between the EPO group and the placebo group. In an intent-to-treat analysis, the mean MDI was 93.5 in the EPO group and 94.5 in the placebo group (P=0.056). In the per-protocol analysis, the mean MDI was 93.9 and 94.5, respectively (P=0.70).
The researchers also found no significant differences between the treatment groups for secondary outcomes such as motor development, cerebral palsy, hearing or visual impairment, and anthropometric growth parameters.
The team assessed motor development using the psychomotor development index (PDI). In the intent-to-treat analysis, the mean PDI was 89.5 in the EPO group and 92.1 in the placebo group (P=0.15). In the per-protocol analysis, the mean PDI was 89.2 and 92.8, respectively (P=0.06).
In the intent-to-treat analysis, the incidence of cerebral palsy was 4% in the EPO group and 5% in the placebo group (P>0.99). In the per-protocol analysis, it was 5% for both groups (P=0.41).
In the intent-to-treat analysis, severe hearing impairment occurred in 1 EPO-treated patient and no placebo-treated patients (P>0.99). Severe visual impairment occurred in 2 and 0, respectively (P=0.50). The incidences were the same in the per-protocol analysis.
And there were no significant differences between the treatment groups (per-protocol or intent-to-treat) when it came to growth parameters such as head circumference, weight, or length.
The researchers said these results suggest that EPO may not have a neuroprotective role in very preterm infants, but follow-up is required to assess cognitive and physical problems that may not become evident until later in life.