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Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants

NCT03169881 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2025-11-17

Study results available
· View outcomes & findings →

Summary

Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo

Conditions

  • Neurocognitive
  • Neuroprotective
  • Neonatal
  • Neurodevelopmental Impairment

Interventions

DRUG

Placebo

normal saline for IV administration, or sham dosing. Infants will be treated until 35 completed weeks gestation, discharge, or transfer to another hospital.

DRUG

Darbepoetin

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • NICHD Neonatal Research Network

    lead NETWORK

Principal Investigators

  • Robin Ohls, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-20
Primary Completion
2022-12-23
Completion
2025-05-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03169881 on ClinicalTrials.gov