A trial to determine if cooling newborn infants at risk of brain damage improves outcome

Conditions

None listed

Jacobs SE, Morley CJ, Inder TE, Stewart MJ, Smith KR, McNamara PJ, Wright IM, Kirpalani HM, Darlow BA, Doyle LW, Infant Cooling Evaluation Collaboration.

2011-04-04447 citations

10.1001/archpediatrics.2011.43

Papers published before 2004-04-06 may not appear yet. Historical indexing is in progress.

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

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

35 Weeks to No maximum

Healthy volunteers

No

Inclusion criteria

1) 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 criteria

1) 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

Outcome results