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Could cooling Babies' brains after mild birth injury boost IQ?

NCT ID NCT05889507

Disease control Sponsor: Imperial College London Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether cooling the body of newborns who had a mild lack of oxygen at birth can improve their brain development by age 2. About 426 babies will be randomly assigned to either whole-body cooling or normal temperature care. The goal is to see if cooling leads to better thinking and learning skills compared to standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
whole-body cooling (hypothermia)
What this could lead to
If it works, cooling could become standard care for mild newborn brain injury, improving long-term thinking and learning skills.
What could go wrong
This is a large trial, but cooling is already used for severe cases; its benefit for mild cases is unproven. There is a small risk of side effects from cooling, and results won't be known for years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 426 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 hour to 6 hours

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

perinatal asphyxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neonatal encephalopathy Newborn asphyxia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    39 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Birmingham Heartlands

    RECRUITING

    Birmingham, United Kingdom

  • Bradford Royal Infirmary

    RECRUITING

    Bradford, United Kingdom

  • Darent Valley Hospital

    RECRUITING

    Dartford, DA2 8DA, United Kingdom

  • Derriford Hosptial

    RECRUITING

    Plymouth, United Kingdom

  • Homerton University Hospital

    RECRUITING

    London, United Kingdom

  • Imperial College Healthcare NHS FT

    RECRUITING

    London, United Kingdom

  • John Radcliffe Hospital

    RECRUITING

    Oxford, OX3 9DU, United Kingdom

  • Leeds centre for Newborn Care (Leeds General Infirmary)

    RECRUITING

    Leeds, United Kingdom

  • Leicester Royal Infirmary

    RECRUITING

    Leicester, United Kingdom

  • Liverpool Women's Hospital

    RECRUITING

    Liverpool, United Kingdom

  • Luton and Dunstable Hospital

    RECRUITING

    Luton, United Kingdom

  • Medway Maritime Hospital

    RECRUITING

    Gillingham, United Kingdom

  • Neonatal Unit, Università degli Studi della Campania "Luigi Vanvitelli"

    RECRUITING

    Naples, Italy

  • Newham General Hosptial

    RECRUITING

    London, United Kingdom

  • Northwick Park Hospital

    RECRUITING

    London, United Kingdom

  • Princess Royal Hospital

    RECRUITING

    Haywards Heath, RH16 4EX, United Kingdom

  • Queen's Hospital, Barking

    RECRUITING

    London, United Kingdom

  • Queens Medical Centre Nottingham

    RECRUITING

    Nottingham, United Kingdom

  • Rosie Maternity Hosptial, Addenbrookes

    RECRUITING

    Cambridge, United Kingdom

  • Royal Albert Edward Infirmary

    RECRUITING

    Wigan, United Kingdom

  • Royal Bolton Hosptial

    RECRUITING

    Bolton, United Kingdom

  • Royal Devon and Exeter Hospital

    RECRUITING

    Exeter, United Kingdom

  • Royal London Hospital

    RECRUITING

    London, United Kingdom

  • Royal Sussex County Hospital

    RECRUITING

    Brighton, BN2 5BE, United Kingdom

  • Royal Victoria Infirmary

    RECRUITING

    Newcastle upon Tyne, United Kingdom

  • Simpson Centre for Reproductive Health NHS Lothian

    RECRUITING

    Edinburgh, United Kingdom

  • Southmead Hosptial

    RECRUITING

    Bristol, United Kingdom

  • St Mary's Hospital

    RECRUITING

    Manchester, United Kingdom

  • St Michael's Hospital

    RECRUITING

    Bristol, BS2 8EG, United Kingdom

  • St Peters Hosptial

    RECRUITING

    Ashford, United Kingdom

  • St Thomas Hospital

    RECRUITING

    London, United Kingdom

  • Turnbridge Wells Hospital

    RECRUITING

    Royal Tunbridge Wells, TN2 4QJ, United Kingdom

  • University Hospital Coventry

    RECRUITING

    Coventry, United Kingdom

  • University Hospital of Wales

    RECRUITING

    Wales, United Kingdom

  • Whipps Cross Hospital

    RECRUITING

    London, United Kingdom

  • Whiston Hospital

    RECRUITING

    Whiston, United Kingdom

  • William Harvey Hospital

    RECRUITING

    Ashford, TN24 0LZ, United Kingdom

  • Worthing Hospital

    RECRUITING

    Worthing, United Kingdom

  • Wythenshawe Hosptial

    RECRUITING

    Manchester, United Kingdom

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