Actively Recruiting
Cooling in Mild Encephalopathy
Led by Imperial College London · Updated on 2026-02-06
426
Participants Needed
39
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 Development 4th Edition (Bayley-IV) examination at 24 (±2) months of age. Researchers will compare the mean Cognitive Composite Scale score from the Bayley IV examination between the two groups.
CONDITIONS
Official Title
Cooling in Mild Encephalopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Babies born at or after 36 weeks of gestation
- Birth weight of 1800 grams or more
- Evidence of intra-partum hypoxia-ischemia defined by any of the following: Apgar score less than 6 at 10 minutes, continued need for resuscitation at 10 minutes, or severe birth acidosis (pH �37.00 or Base deficit �316 mmol/l within 60 minutes of birth)
- Evidence of mild hypoxic ischaemic encephalopathy with two or more abnormal findings on modified Sarnat examination but not moderate or severe HIE
- Normal amplitude EEG performed for at least 30 minutes between 1 to 6 hours of age, with specific amplitude criteria
You will not qualify if you...
- Infants who meet criteria for whole-body hypothermia for moderate or severe HIE
- Infants without encephalopathy (less than two abnormalities on neurological exam)
- Infants with major congenital or chromosomal anomalies
- Infants with birth weight less than 1800 grams
- Infants who have received sedation, muscle relaxants, or anti-convulsants before neurological assessment
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Trial Site Locations
Total: 39 locations
1
Neonatal Unit, Università degli Studi della Campania "Luigi Vanvitelli"
Naples, Italy
Actively Recruiting
2
William Harvey Hospital
Ashford, United Kingdom, TN24 0LZ
Actively Recruiting
3
St Peters Hosptial
Ashford, United Kingdom
Actively Recruiting
4
Birmingham Heartlands
Birmingham, United Kingdom
Actively Recruiting
5
Royal Bolton Hosptial
Bolton, United Kingdom
Actively Recruiting
6
Bradford Royal Infirmary
Bradford, United Kingdom
Actively Recruiting
7
Royal Sussex County Hospital
Brighton, United Kingdom, BN2 5BE
Actively Recruiting
8
St Michael's Hospital
Bristol, United Kingdom, BS2 8EG
Actively Recruiting
9
Southmead Hosptial
Bristol, United Kingdom
Actively Recruiting
10
Rosie Maternity Hosptial, Addenbrookes
Cambridge, United Kingdom
Actively Recruiting
11
University Hospital Coventry
Coventry, United Kingdom
Actively Recruiting
12
Darent Valley Hospital
Dartford, United Kingdom, DA2 8DA
Actively Recruiting
13
Simpson Centre for Reproductive Health NHS Lothian
Edinburgh, United Kingdom
Actively Recruiting
14
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Actively Recruiting
15
Medway Maritime Hospital
Gillingham, United Kingdom
Actively Recruiting
16
Princess Royal Hospital
Haywards Heath, United Kingdom, RH16 4EX
Actively Recruiting
17
Leeds centre for Newborn Care (Leeds General Infirmary)
Leeds, United Kingdom
Actively Recruiting
18
Leicester Royal Infirmary
Leicester, United Kingdom
Actively Recruiting
19
Liverpool Women's Hospital
Liverpool, United Kingdom
Actively Recruiting
20
Homerton University Hospital
London, United Kingdom
Actively Recruiting
21
Imperial College Healthcare NHS FT
London, United Kingdom
Actively Recruiting
22
Newham General Hosptial
London, United Kingdom
Actively Recruiting
23
Northwick Park Hospital
London, United Kingdom
Actively Recruiting
24
Queen's Hospital, Barking
London, United Kingdom
Actively Recruiting
25
Royal London Hospital
London, United Kingdom
Actively Recruiting
26
St Thomas Hospital
London, United Kingdom
Actively Recruiting
27
Whipps Cross Hospital
London, United Kingdom
Actively Recruiting
28
Luton and Dunstable Hospital
Luton, United Kingdom
Actively Recruiting
29
St Mary's Hospital
Manchester, United Kingdom
Actively Recruiting
30
Wythenshawe Hosptial
Manchester, United Kingdom
Actively Recruiting
31
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Actively Recruiting
32
Queens Medical Centre Nottingham
Nottingham, United Kingdom
Actively Recruiting
33
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
34
Derriford Hosptial
Plymouth, United Kingdom
Actively Recruiting
35
Turnbridge Wells Hospital
Royal Tunbridge Wells, United Kingdom, TN2 4QJ
Actively Recruiting
36
University Hospital of Wales
Wales, United Kingdom
Actively Recruiting
37
Whiston Hospital
Whiston, United Kingdom
Actively Recruiting
38
Royal Albert Edward Infirmary
Wigan, United Kingdom
Actively Recruiting
39
Worthing Hospital
Worthing, United Kingdom
Actively Recruiting
Research Team
S
Sudhin Thayyil, MD, PhD
CONTACT
R
Reema Garegrat, MD, DNB, MRCPCH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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