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
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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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