RecruitingPhase 3ACTRN12606000036516

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)


Sponsor

Murdoch Children's Research Institute

Enrollment

300 participants

Start Date

Nov 8, 2000

Study Type

Interventional

Conditions


Eligibility

Sex: Both males and femalesMin Age: 35 Weekss

Plain Language Summary

Simplified for easier understanding

This study is testing whether cooling newborn babies who may have brain damage from lack of oxygen during birth can improve their outcomes. When a baby doesn't get enough oxygen around the time of birth, the brain can be injured. Researchers believe that lowering the baby's body temperature shortly after birth may help protect the brain and lead to better long-term health. You may be eligible if: - The baby was born at 35 weeks of pregnancy or later - The baby can be treated at or transported to one of the study sites - The baby shows signs of moderate or severe brain injury (encephalopathy) - There is evidence of oxygen deprivation during labour, such as: an Apgar score of 5 or less at 10 minutes, need for breathing support at 10 minutes, or very low blood acid levels within 60 minutes of birth You may NOT be eligible if: - Cooling cannot begin within 6 hours of birth - Birth weight is less than 2.0 kg - The baby has a major birth defect (such as chromosomal problems, heart or lung abnormalities, or bleeding disorders) - The baby needs more than 80% oxygen to breathe - The baby is in extremely critical condition with severe low blood pressure or acid levels not responding to treatment - Cooling has already been started before the study begins Talk to your doctor about whether this trial might be right for you.

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

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)

Australia

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ACTRN12606000036516