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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 is a Phase 2 study that has completed, run by University of New Mexico. The registered enrollment target is 28 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03071861
The ClinicalTrials.gov registry entry for NCT03071861 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of New Mexico, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Darbepoetin Alfa is the first listed.
NCT03071861 reports 0 study locations.
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.
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