Cooling in Mild Encephalopathy

Recruiting Phase 3 Interventional Study
Neonatal Encephalopathy Newborn Asphyxia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
1 Hour – 6 Hours
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
426 (estimated)
Sponsor
Imperial College London · Other
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About This Trial
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 hou…
Trial Locations
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Eligibility Criteria
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…
Contacts

Sudhin Thayyil, MD, PhD

02033132473

s.thayyil@imperial.ac.uk

CONTACT

Reema Garegrat, MD, DNB, MRCPCH

02033132473

r.garegrat@imperial.ac.uk

CONTACT