Overview

Mild Encephalopathy in the Newborn Treated With Darbepoetin

Status:
Recruiting

Trial end date:
2021-10-31

Target enrollment:
0

Participant gender:
All

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 and Gross Motor Function Assessment) will be performed at 8-12 months of age. Pharmacokinetics will be assessed on those infants that received Darbe.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of New Mexico

Collaborator:

University of Utah

Treatments:

Darbepoetin alfa

Criteria

Inclusion Criteria: Infants will be eligible for the MEND trial if they have a gestational
age > 34 weeks by best obstetric estimate, are <24 hours old and have evidence of mild
encephalopathy as defined by Shankaran et al based on a modified Sarnat examination
performed at <6 hours of age.

1. History of an acute perinatal event (abruption, cord prolapsed, severe fetal heart
rate abnormality, or meconium staining)

2. Infant is evaluated for hypothermia therapy and DOES NOT meet clinical criteria for
TH.

3. Infant has an IV for clinical treatment

Exclusion Criteria:

1. Moderate/Severe encephalopathy on modified Sarnat examination at < 6 hours of age

2. Major congenital and/or chromosomal abnormalities

3. Prenatal diagnosis of brain abnormality or hydrocephalus

4. Severe growth restriction (< 3%)

5. Central venous hematocrit >65%, platelet count >600,000/dL, and/or neutropenia
(ANC<500 μL)

6. ECMO

7. Infant judged critically ill and unlikely to benefit from neonatal intensive care by
the attending neonatologist