Actively Recruiting

Phase 3
Age: 1Hour - 6Hours
All Genders
NCT05889507

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

Age: 1Hour - 6Hours
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

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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

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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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