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NCT03169881 · ClinicalTrials.gov registry record · Phase 3
Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants
A Phase 3 study, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 650
- Enrollment target
NCT03169881: Completed Phase 3 study, sponsored by NICHD Neonatal Research Network.
NCT03169881 is a Phase 3 study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 650 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03169881, a Phase 3 study, has completed, sponsored by NICHD Neonatal Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 650 participants
- Enrollment target
Study Summary
Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo
Primary Outcome
Bayley Scale of Infant and Toddler Development (BSID)-III composite cognitive score, where subjects who died prior to the follow-up assessment are assigned the lowest possible score of 54. This is a standardized scale where a score that is more than 1 normative standard deviation from the normative mean of 100 signifies mild developmental delay (score \< 85); 2 standard deviations below the mean, moderate delay (score \< 70); and 3 standard deviations below the mean, severe delay (score \< 55).
Interventions
- DRUG Placebo
- DRUG Darbepoetin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 650 participants |
| Start Date | 2017-09-20 |
| Est. Completion | 2025-05-12 |
| Phase | Phase 3 |
What the finished NCT03169881 record still lists
NCT03169881 is an interventional study that assigns participants to a tested intervention. The registered 650 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03169881 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03169881 about?
NCT03169881 is a clinical study titled "Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants". Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo
What is the current status of trial NCT03169881?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 650 participants. The study started on 2017-09-20. Estimated completion is 2025-05-12.
What interventions are being tested in trial NCT03169881?
The interventions under investigation include: Placebo (DRUG), Darbepoetin (DRUG).
Who is sponsoring clinical trial NCT03169881?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03169881's enrollment target sits among peer trials
650 572nd of 2000 higher than 1,429 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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