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Mild Encephalopathy in the Newborn Treated With Darbepoetin

NCT03071861 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-12-21

Study results available
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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.

Conditions

  • Neonatal Encephalopathy
  • Hypoxic-Ischemic Encephalopathy Mild

Interventions

DRUG

Darbepoetin Alfa

Single dose of 10 mcg/kg Darbepoetin Alpha given IV at less than 24 hours of age

DRUG

Normal Saline

Single dose of normal saline, IV, given at less than 24 hours of age

Sponsors & Collaborators

Principal Investigators

  • Tara L DuPont, 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
2017-12-01
Primary Completion
2019-12-01
Completion
2022-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03071861 on ClinicalTrials.gov