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Cooling in Mild Encephalopathy

RecruitingPhase 3Ages 1 Hour - 6 HoursAllImperial College London
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In plain words

What the trial is, and whether it could suit you

The goal of this randomised control trial is to establish the safety and efficacy of whole-body hypothermia for babies with mild hypoxic ischaemic encephalopathy, inform national and international guidelines, and establish uniform practice across the NHS. The main questions it aims to answer are: 1. Does whole-body cooling (33.5±0.5°C) initiated within six hours of birth and continued for 72 hours, improve cognitive development at 24 (±2) months of age after mild neonatal encephalopathy compared with normothermia (37±0.5°C)? 2. Does a prospective trial-based economic evaluation support the provision of cooling therapy for mild encephalopathy in the NHS on cost-effectiveness grounds? Participants will have the following interventions: * Randomisation into one of the following groups * Whole body hypothermia group * Targeted normothermia group * Bayley Scales of Infant and Toddler

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: All babies born at or after 36 weeks of gestation with a birth weight of 1800g or more with birth acidosis or requiring resuscitation at birth will be screened for eligibility. Parents will be approached for consent if the baby meets all the three (A + B + C) criteria below: A. Evidence of intra-partum hypoxia-ischemia defined as any of - (i) Apgar score of \<6 at 10 minutes after birth; (ii) continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth; (iii) severe birth acidosis defined as any occurrence of pH =\<7.00 or a Base deficit \>=16mmol/l in any cord or baby gas sample within 60 minutes of birth. B. Evidence of mild hypoxic ischaemic encephalopathy defined as - two or more abnormal findings in any of the six categories of the modified Sarnat examination (level of consciousness, spontaneous activity, posture, tone, primitive reflexes, and autonomic nervous system) but not meeting the diagnosis of moderate or severe hypoxic ischaemic encephalopathy on a standardised examination performed by a certified examiner between 1 to 6 hours of age. C. Normal amplitude on aEEG performed for at least 30 minutes between 1 to 6 hours of age. Normal amplitude will be defined as upper margin of the aEEG activity more than 10 microvolts and the lower margin more than 5 microvolts on a single channel aEEG. Exclusion Criteria: * Infants who meet the BAPM criteria for whole-body hypothermia * Infants without encephalopathy defined as less than two abnormalities on structured neurological examination. * Infants with major congenital or chromosomal anomalies identified prior to randomisation. * Infants with birthweight \<1800g. * Infants who have already received sedation, muscle relaxation, or anti-convulsants prior to neurological assessment.
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What it tests

  • Whole body hypothermia
  • Targeted normothermia
  • Supportive neonatal intensive care
  • Follow up assessment at 2 years of age
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Where

39 sites
Neonatal Unit, Università degli Studi della Campania "Luigi Vanvitelli"
Naples, Italy
William Harvey Hospital
Ashford, United Kingdom
St Peters Hosptial
Ashford, United Kingdom
Birmingham Heartlands
Birmingham, United Kingdom
Royal Bolton Hosptial
Bolton, United Kingdom
Bradford Royal Infirmary
Bradford, United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
St Michael's Hospital
Bristol, United Kingdom

…and 31 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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