An interventional study of Therapeutic hypothermia in Neonatal Encephalopathy, Hypothermia Neonatal and Magnetic Resonance Spectroscopy, sponsored by Thayyil, Sudhin. Active, not recruiting at 8 sites in 3 countries. Open to participants aged Up to 6 Hours. Per ClinicalTrials.gov, last updated 2023-08-04.
Sponsored by Thayyil, Sudhin · Not applicable, Interventional, and Treatment
Among 24 studies in Hypothermia with a site in United Kingdom — 3 open to participants now, 4 under way, none of them phase 3. Hypothermia · United Kingdom.
Among the 24 studies in Hypothermia with a site in United Kingdom, this one is the 4th largest by planned enrollment of the 18 interventional ones, is one of 2 that started in 2019, is one of 15 with no phase, and was the 19th registered.
449 studies on the registry are indexed under Hypothermia; 54 are open to participants now.
This study's planned enrollment of 140 is above the median of 77 across 328 interventional studies indexed under Hypothermia.
Browse Hypothermia studies →3 of the 24 studies in Hypothermia with a site in United Kingdom are open now, in 12 countries. Each count lists the studies.
Of the 27 Hypothermia studies recruiting now, 13 (48%) set no upper age limit and 12 (44%) stop at 75 or younger; 12 take children under 18; 6 take healthy volunteers.
This study: Up to 6 Hours · all sexes · no healthy volunteers.
The full table on the hub →24 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 2 started in 2019.
Median enrollment 82 across the 18 interventional studies, 194 across the 6 observational. Of the 17 that completed or were terminated, 5 (29%) have results posted.
4 of 24 have an industry lead sponsor. The 10 most frequent:
Thayyil, Sudhin is the lead sponsor of 6 studies on the registry; none are open to participants now.
Thayyil, Sudhin has 2 studies filed under Hypothermia — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 24 studies in Hypothermia with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
Phase II randomised control trial of whole body cooling in mild neonatal encephalopathy.
Although therapeutic hypothermia for 72 hours reduces brain injury and improves long term neurodevelopmental outcomes after moderate or severe neonatal encephalopathy, the benefits and optimal duration of cooling therapy in mild encephalopathy is not known. Adverse neurodevelopmental outcomes at 2 years occur in 16% of babies with un-treated mild neonatal encephalopathy. In the phase I of the COMET trial, we have shown that it is feasible to identify and randomise babies with mild encephalopathy, and to obtain the primary outcome (proton MR spectroscopy levels of Thalamic N-acetyl Aspartate) accurately. The phase II of the COMET trial will examine the benefits and optimal duration of cooling therapy in babies with mild encephalopathy.
Research questions
Study Population Cohort 1: A total of 60 babies with mild encephalopathy (>36 weeks; >2Kg) aged less than 6 hours will be recruited from several tertiary neonatal units in the UK, Europe, USA and Canada, over a 2 year period. The babies will be randomised to usual care (no cooling) or cooling therapy (core temperature 33 to 34 C) for 72 hours within six hours of birth. MR imaging and spectroscopy will be performed between 4 to 14 days after birth.
Cohort 2: A total of 80 babies will mild encephalopathy (>36 weeks; >2Kg) aged 24 to 48 hours and undergoing cooling therapy as a part of standard clinical care will be recruited from several UK cooling centres, over a 2 year period. The babies will be randomised to rewarming after 48 hours or 72 hours of cooling therapy. MR imaging and spectroscopy will be performed between 4 to 14 days after birth. The babies recruited to cohort 1 will not be eligible for recruitment to cohort 2.
Primary outcome (both cohorts)
Benefits of the trial These data will inform the national and international guidelines on management of babies with mild neonatal encephalopathy. If a shorter duration of cooling is as good or better than 3 days of cooling, this will reduce the intensive care stays, opioid use and separation from parents.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All of the following three criteria should be met:
Evidence of acute perinatal asphyxia
Metabolic acidosis (pH \<7.0 and/or BE >-16) in cord gas or a blood gas within one of birth.
OR
EXCLUSION CRITERIA
The following group of babies will be excluded prior to randomisation
Usual care (normothermia) arm
Whole body cooling (33 to 34 C) for 48 hours
Other: Therapeutic hypothermia
Whole body cooling (33 to 34 C) for 72 hours
Other: Therapeutic hypothermia
Whole body cooling using a servo controlled device
Thalamic N-acetyl aspartate level
Feasibility of obtaining Proton MR spectroscopy thalamic N-acetyl aspartate level
Time frame: 4 to 14 days after birth
Brain injury on conventional MR imaging
Cortical, white matter or deep nuclei injury
Time frame: 4 to 14 days after birth
Hospital stay
Duration of hospital stay
Time frame: Upto 30 days after birth
Plan to share: Yes — Data can be shared unconditionally will be made available when scientific manuscripts are published. Data that cannot be shared publicly (e.g. to protect patient confidentiality) will be by request only. The PI will review each request on case-by-case basis. Upon approval the data requester will be asked to sign a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will be available 3 to 6 after the end of the study.
Access criteria: Unidentified data will be shared by publication. Request for data that affects patient confidentiality will review by the study PI on a case-by-case basis.
Started Oct 2019 (actual). Primary completion is estimated for Jun 2024, 56 months after the start.
Of 132 non-industry interventional studies with no phase under Hypothermia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 56 months is above that.
Counting every sponsor, half of 135 studies reached it within 16 months; a quarter within 6 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Thayyil, Sudhin