At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 650 enrolled
Drug / intervention
Darbepoetin +1 moredrug
Likely dose
Darbepoetin 10 microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants
In Brief
A Phase 3 clinical trial evaluating Darbepoetin and Placebo for Neurocognitive and 3 related conditions. Completed, enrolled 650 participants across 16 sites.
Detailed Summary
Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartSep 2017
Primary CompletionDec 2022
Study CompletionMay 2025
TodayJul 2026
First PostedMay 30, 2017
Enrollment StartSep 20, 2017
Primary CompletionDec 23, 2022
Study CompletionMay 12, 2025
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 9.1 years ago
Interventions
Darbepoetindrug
Darbepoetin 10 micrograms/kg/once every week (IV or SC). Infants will be treated until 35 completed weeks gestation, discharge, or transfer to another hospital.
Placebodrug
normal saline for IV administration, or sham dosing. Infants will be treated until 35 completed weeks gestation, discharge, or transfer to another hospital.