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Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants
Study ID: STU 072017-084
Summary
advances in neonatal care have led to significant improvements in the survival of the nearly 60,000 very low birth weight (VLBW) infants born each year in the u.S.improving neurodevelopmental outcomes for these preterm infants continues to be a major goal for neonatal care providers. although a variety of neuroprotective treatment strategies have been evaluated, no specific treatment has been identified to reduce or prevent brain injury in these most vulnerable preterm infants. a potential neuroprotective therapy involves administering erythropoiesis stimulating agents (eSas) such as erythropoietin (epo) and Darbepoetin (Darbe, a longer acting eSa). in addition to stimulating erythropoiesis, eSas have been shown to be protective in the developing brain in animal models, making it possibly beneficial for very premature infants who are at risk for intraventricular hemorrhage, hypoxic-ischemic injury, and developmental delay. We previously published data suggesting a relationship between serum epo concentrations and cognitive outcomes in eLBW infants. Based on preliminary pharmacokinetic and erythrokinetic data on the administration of Darbe to preterm infants, we propose a randomized, masked, controlled study to evaluate effects on red cell mass and developmental preterm outcomes. enrolled infants will receive weekly Darbe or placebo (sham) dosing. Laboratory tests will be performed on all infants while in the hospital. Transfusions will be administered via protocol. neurodevelopmental assessment will be performed at 22-26 months. The primary outcome is the Bayley iii cognitive score. Deaths will be assigned a score of 54. The trial will analyze all enrolled infants as above, and will randomize infants 23 0/7-28 6/7 weeks Ga into two groups Darbe and placebo) in a 1:1 ratio. The primary hypothesis will evaluate whether infants receiving Darbe have higher cognitive scores at 22-26 months follow up, using a two-tailed test with 5% type 1 error and 90% power. Secondary outcomes that will be followed include: hematocrit, red cell mass, number and volume of transfusions, donor exposures, hospital days, and differences in morbidities (thromboses, hypertension, seizures, iCH, neC requiring surgery, BPD, RoP requiring intervention, culture positive sepsis); nDi, death, nDi or death, and CP at 22-26 months.
Participant Eligibility
Inclusion Criteria * 23 0/7-28 6/7 weeks gestation * < 24 hours postnatal age
- Cancer Related
- No
- Healthy Volunteers
- No
- UT Southwestern Principal Investigator
- LINA FAHD CHALAK
NIH-NATIONAL HEART, LUNG AND BLOOD INST
Other
Primary Hypothesis: Preterm infants administered weekly Darbe starting within 36 hours of birth and continuing to 35 weeks gestational age will have improved neurocognitive outcome at 22-26 months (with deaths assigned the lowest possible score of 54), compared to placebo recipients. Secondary Hypotheses: 1. Preterm infants administered weekly Darbe during the neonatal period will have increased red cell mass, decreased transfusions, decreased donor exposures, and decreased volume of transfused red cells compared to placebo infants 2. Preterm infants administered weekly Darbe during the neonatal period will have improved survival without neurodevelopmental impairment compared to placebo infants 3. Preterm infants with peak serum epo concentrations [GreaterThanorequalTo]500mu/mL will have better neurocognitive development than those who have peak serum epo concentrations [Less Than]500mu/mL 4. Preterm infants administered weekly Darbe will have a decreased incidence of cerebral palsy compared to placebo infants 5. Preterm infants administered weekly Darbe who receive at least 1 transfusion will have improved cognitive outcome compared to placebo infants who receive at least 1 transfusion