# NICHD whole-body cooling trial for birth asphyxia

Study · id `maternal:nichd-whole-body-cooling-trial` · Maternal & Newborn Atlas · release `c7fb95f1d15a7d13` (public)

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Browse, life stage: Newborn  
Browse, care area: Newborn care  

## In plain language

A trial in US hospitals of the NICHD Neonatal Research Network that compared cooling with usual care in term babies with brain injury after birth asphyxia.

## Technical summary

Randomised, parallel-group trial (ClinicalTrials.gov NCT00005772, phase 3, masking none). The 2005 main report gives 102 infants assigned to cooling and 106 to usual care. The lead sponsor named on the registry is the NICHD Neonatal Research Network.

## Key facts

- Design: Randomised, parallel-group trial of whole-body cooling in infants of at least 36 weeks of gestation with moderate or severe encephalopathy. The paper cooled to an esophageal temperature of 33.5 degrees C for 72 hours, followed by slow rewarming; the registry describes cooling over 96 hours. Registry masking: none.
- Phase: Phase 3
- Enrolled: 208 infants (ClinicalTrials.gov gives no unit for the count) (enrolled count; Whole-Body Cooling for Birth Asphyxia in Term Infants, snapshot `maternal:ctgov-nct00005772-2026-10-14`, retrieved 2026-10-14)
- Started: 1999-10 (Whole-Body Cooling for Birth Asphyxia in Term Infants, snapshot `maternal:ctgov-nct00005772-2026-10-14`, retrieved 2026-10-14)
- Primary completion: 2003-05 (actual) (Whole-Body Cooling for Birth Asphyxia in Term Infants, snapshot `maternal:ctgov-nct00005772-2026-10-14`, retrieved 2026-10-14)
- Completion: 2010-07 (actual) (Whole-Body Cooling for Birth Asphyxia in Term Infants, snapshot `maternal:ctgov-nct00005772-2026-10-14`, retrieved 2026-10-14)
- Countries: United States (Whole-Body Cooling for Birth Asphyxia in Term Infants, snapshot `maternal:ctgov-nct00005772-2026-10-14`, retrieved 2026-10-14)
- Care setting: Not reported
- Registry status: "COMPLETED" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `maternal:ctgov-nct00005772-2026-10-14`, retrieved 2026-10-14)

## Connected pages

- Tests whole-body cooling: Cooling treatment (therapeutic hypothermia) for HIE (`maternal:therapeutic-hypothermia`)
- Primary results, NEJM 2005: Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy (NEJM 2005) (`maternal:pub-nichd-cooling-nejm-2005`)
- Lead sponsor named on the registry record: NICHD Neonatal Research Network (`maternal:nichd-nrn`)

## Provenance

Content hash: 5dc237ea67d41126b34bda78f1414c0f579821d253c7b003ff95ca22bf078be2
Last substantive edit: 2026-10-14
Evidence last checked: Not recorded