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

Phase 3

Recruiting

• Conditions: Term infants with hypoxic ischaemic encephalopathy; Reproductive Health and Childbirth - Complications of newborn; Reproductive Health and Childbirth - Children's - Brain

• Registration Number: ACTRN12606000036516
• Lead Sponsor: Murdoch Children's Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified