Whole-body cooling for babies with mild neonatal encephalopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase III, multi‑centre, open‑label randomized trial comparing whole‑body hypothermia (33.5±0.5°C for 72 hours) started within six hours of birth versus targeted normothermia (37±0.5°C) in term newborns with mild hypoxic‑ischaemic encephalopathy. Babies are randomized at the birth hospital and transferred to a cooling centre if required, with outcome assessments masked to treatment allocation. The primary neurodevelopmental outcome is measured with the Bayley Scales of Infant and Toddler Development (Bayley‑IV) at 24 (±2) months; the protocol also includes a trial‑based economic evaluation. The trial includes an internal pilot and aims to inform national practice and guidelines across the NHS.

Why it matters

Who can join: the full rules

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.

Where it's running

• Neonatal Unit, Università degli Studi della Campania "Luigi Vanvitelli"
  Naples, Italy Recruiting
• William Harvey Hospital
  Ashford, United Kingdom Recruiting
• St Peters Hosptial
  Ashford, United Kingdom Recruiting
• Birmingham Heartlands
  Birmingham, United Kingdom Recruiting
• Royal Bolton Hosptial
  Bolton, United Kingdom Recruiting
• Bradford Royal Infirmary
  Bradford, United Kingdom Recruiting

Study contacts

• Principal investigator: Sudhin Thayyil, PhD — Imperial College London
• Study coordinator: Sudhin Thayyil, MD, PhD
• Email: s.thayyil@imperial.ac.uk
• Phone: 02033132473

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.