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NCT03071861 · ClinicalTrials.gov registry record · Phase 2
Mild Encephalopathy in the Newborn Treated With Darbepoetin
A Phase 2 study, sponsored by University of New Mexico.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT03071861: Completed Phase 2 study, sponsored by University of New Mexico.
NCT03071861 is a Phase 2 study that has completed, run by University of New Mexico. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03071861, a Phase 2 study, has completed, sponsored by University of New Mexico.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study Summary
This is a Phase II multicenter placebo-controlled randomized, feasibility/safety trial. Infants \>34 week gestational age with perinatal acidemia and mild neonatal encephalopathy on the modified Sarnat neurologic examination at less than six hours of age. Participants will be randomized to receive either one dose of Darbepoetin, or placebo within 24 hours of birth. Neurodevelopmental testing (Bayley (III or IV) and Gross Motor Function Assessment) will be performed at 24 months of age. Pharmacokinetics will be assessed on those infants that received Darbe.
Primary Outcome
The Bayley III and Neuromuscular Assessment were completed between 9-12 months of age. Subjects were abnormal if they had a Bayley III score of less than 70 and/or an abnormal neurological examination.
Interventions
- DRUG Darbepoetin Alfa
- DRUG Normal Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2017-12-01 |
| Est. Completion | 2022-09-01 |
| Phase | Phase 2 |
What the finished NCT03071861 record still lists
NCT03071861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Darbepoetin Alfa is the first listed.
NCT03071861 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03071861 about?
NCT03071861 is a clinical study titled "Mild Encephalopathy in the Newborn Treated With Darbepoetin". This is a Phase II multicenter placebo-controlled randomized, feasibility/safety trial. Infants \>34 week gestational age with perinatal acidemia and mild neonatal encephalopathy on the modified Sarnat neurologic examination at less than six hours of age. Participants will be randomized to receive e...
What is the current status of trial NCT03071861?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2017-12-01. Estimated completion is 2022-09-01.
What interventions are being tested in trial NCT03071861?
The interventions under investigation include: Darbepoetin Alfa (DRUG), Normal Saline (DRUG).
Who is sponsoring clinical trial NCT03071861?
This trial is sponsored by University of New Mexico, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03071861's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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