A trial to determine if cooling newborn infants at risk of brain damage improves outcome
A randomised controlled trial of the effect of whole body cooling on the outcome of term infants with hypoxic ischaemic encephalopathy (ICE:Infant Cooling Evaluation trial)
Murdoch Children's Research Institute
300 participants
Nov 8, 2000
Interventional
Conditions
Eligibility
Inclusion Criteria1
- Infants of 35 weeks’ gestation or more, 2) Treatment at, or transport to, one of the participating study sites.3) Evidence of moderate or severe encephalopathy:4) Evidence of intrapartum hypoxia: at least two of: a)Apgar score of 5 or less at 10 minutes; b)Mechanical ventilation or resuscitation at 10 minutes; c)Cord pH < 7.00, or an arterial pH < 7.00 or base deficit of 12 or more within 60 minutes of birth
Exclusion Criteria1
- Cooling cannot be started within 6 hours of birth.2) Birth weight less than 2.0 kg3) Major congenital abnormalities including: a) Suspected neuromuscular disorders b) Chromosomal abnormalities c) Life threatening abnormalities of the cardiovascular or respiratory systems d) Suspected coagulopathye) Imperforate anus.4) Infants requiring an inspired oxygen over 80%.5) Infant in extremis i.e. very low blood pressure or severe acidosis unresponsive to treatment6) Active cooling has been initiated prior to randomisation
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Interventions
Cooling protocol This group will have their core temperature lowered to 33.0oC-34.0oC. Temperature will be measured continuously by a thermistor inserted 5 cm into the rectum. Cooling will be started at the birth hospital after the infant has been assessed and stabilised. Cooling will be started and then continued for 72 hours. It will be achieved primarily by turning the radiant warmer off and exposing the infant to ambient temperature. Cool packs around 10oC may then be applied under the neck and across the chest as needed. Active cooling will be reduced when the rectal temperature falls below 35 oC and stopped when below 34.5oC. The radiant warmer will be on with the skin temperature servo control set at 33.5oC. . After 72 hours, re-warming will occur at a rate not exceeding 0.5OC every 2 hours.
Locations(1)
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ACTRN12606000036516