Darbe Administration in Newborns Undergoing Cooling for Encephalopathy (DANCE)
Hypoxic Ischemic Encephalopathy
About this trial
This is an interventional treatment trial for Hypoxic Ischemic Encephalopathy focused on measuring Hypoxic Ischemic Encephalopathy, Cooling Therapy, HIE
Eligibility Criteria
Inclusion Criteria:
Infants will be eligible for the DANCE trial if they have a gestational age > 36 weeks by best obstetric estimate, are < 12 hours old and have evidence of moderate-severe acute perinatal HIE. Eligibility will also include criteria presently used in the NICU to initiate hypothermia:
- < 6 hours after birth
- History of an acute perinatal event (abruption, cord prolapsed, severe fetal heart rate abnormality)
- Severe fetal or early (< 1 hour age) neonatal acidosis: arterial pH ≤ 7.0 or a base deficit ≥ 16m mEq/ L
If a blood gas is not available or a blood gas at <1 hour of age has a pH between 7.01 and 7.15, or a base deficit is between 10 and 15.9 mEq/L, additional criteria will be required:
- acute perinatal event AND
- either a 10-min Apgar score ≤ 5 or assisted ventilation initiated at birth and continued for at least 10 minutes.
Exclusion Criteria:
- Major congenital and/or chromosomal abnormalities
- Prenatal diagnosis of brain abnormality or hydrocephalus
- Severe growth restriction (< 1800g)
- Central venous hematocrit > 65%, platelet count > 600,000/dL, and/or neutropenia (ANC < 500 µL)
- Maternal history of major vascular thrombosis or multiple fetal losses (> 3 spontaneous abortions)
- ECMO
- Infant judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist
Sites / Locations
- University of New Mexico
- Vanderbilt University School of Medicine
- McKay Dee Hospital- Intermountain Healthcare
- University of Utah
- Primary Children's Hospital
- Intermountain Medical Center
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
High dose Darbepoetin alfa
Low dose Darbepoetin alfa
Placebo
10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days
2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.
Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old