CompletedPhase 2

Mild Encephalopathy in the Newborn Treated With Darbepoetin

United States28 participantsStarted 2017-12-01

Plain-language 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.

Who can participate

Age range1 Hour – 24 Hours

SexALL

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Inclusion criteria

✓. History of an acute perinatal event (abruption, cord prolapsed, severe fetal heart rate abnormality, or meconium staining)
✓. Infant is evaluated for hypothermia therapy and DOES NOT meet clinical criteria for TH.
✓. Infant has an IV for clinical treatment

Exclusion criteria

✕. Moderate/Severe encephalopathy on modified Sarnat examination at \< 6 hours of age
✕. Major congenital and/or chromosomal abnormalities
✕. Prenatal diagnosis of brain abnormality or hydrocephalus
✕. Severe growth restriction (\< 3%)
✕. Central venous hematocrit \>65%, platelet count \>600,000/dL, and/or neutropenia (ANC\<500 μL)
✕. ECMO
✕. Infant judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist

What they're measuring

Normal Neurodevelopment

Timeframe: 9 - 12 months of age

Trial details

NCT IDNCT03071861

SponsorUniversity of New Mexico

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-01

Results submitted2022-11-23

View on ClinicalTrials.gov More Neonatal Encephalopathy trials