Phase 3
N=256
Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy
Hypoxic-Ischemic Encephalopathy
Bottom Line
View on ClinicalTrials.gov: NCT00890409 ↗Enrolled (actual)
256
Serious AEs
—
Results posted
Apr 2009
Primary outcome: Primary: Death — 27; 22 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cooling cap (YJW608-04B) (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Fudan University
- Primary completion
- Jun 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Death |
27; 22 | — |
| PRIMARY Severe Neurodevelopmental Disability |
19; 11 | — |
| SECONDARY Major Adverse Events |
3; 4 | — |
Summary
The purpose of this study is to investigate the effectiveness and safety of selective head cooling (SHC) in neonatal hypoxic-ischemic encephalopathy (HIE).
Eligibility Criteria
Inclusion Criteria
- Age up to 6 hours
- Gestational age ≥ 36 weeks and birth weight ≥ 2500 g
- Apgar score ≤ 3 at 1 minute and ≤ 5 at 5 minutes, and/or cord blood gas pH < 7.0 or base deficit ≤ 16 mmol/L, and/or need for resuscitation or ventilation at 5 minutes of age
- Clinical signs of encephalopathy (seizures, coma, abnormal muscle tone and irregular breathing, etc)
Exclusion Criteria
- Major congenital abnormalities
- Infection
- Other etiology of induced brain injury
- Severe anemia (Hb < 120 g/L)
Eligible infants assessed for the severity of HIE according to criteria of the Neonatal Association of Chinese Academy of Pediatrics 25 modified from Sarnat and Sarnat 26 in 1986
Data sourced from ClinicalTrials.gov (NCT00890409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.