Status:
COMPLETED
Darbe Administration in Newborns Undergoing Cooling for Encephalopathy
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Thrasher Research Fund
Conditions:
Hypoxic Ischemic Encephalopathy
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE1
PHASE2
Brief Summary
Selective head cooling or whole body hypothermia has become the standard of care for neonatal hypoxia-ischemia encephalopathy (HIE). Despite early intervention death or major neurodevelopmental disabi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01471015
Start Date
September 1 2012
End Date
January 1 2014
Last Update
July 23 2024
Active Locations (7)
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1
University of New Mexico
Albuquerque, New Mexico, United States, 87131-0001
2
Vanderbilt University School of Medicine
Nashville, Tennessee, United States, 37232-9544
3
McKay Dee Hospital- Intermountain Healthcare
Ogden, Utah, United States, 84403
4
University of Utah
Salt Lake City, Utah, United States, 84108