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.
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