Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy (NCT00890409) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy
China256 participantsStarted 2002-05
Plain-language summary
The purpose of this study is to investigate the effectiveness and safety of selective head cooling (SHC) in neonatal hypoxic-ischemic encephalopathy (HIE).
Who can participate
Age range6 Hours
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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