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Cooling in Mild Encephalopathy

Study acronym: COMET
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 15 to 39v5
  2. Phase: Not applicable to Phase 3 Trial status: Not Yet Recruiting to Recruiting · Primary and study completion dates: Mar 30, 2029 to Jan 1, 2030 · Study sites: 19 to 15 · 4 morev4 Show 7 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Mar 30, 2029 to Jan 1, 2030
    • Study sites: 19 to 15
    • Start date changed from estimate of May 1, 2024 to Mar 15, 2024
    • Eligibility criteria revised
    • Study description shortened, about 15 words
    • Publications: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  3. Lead sponsor: Thayyil, Sudhin to Imperial College London Start date: Sep 1, 2023 to May 1, 2024 · Study description expanded, about 121 words · Study title shortened, about 3 wordsv3 Show 3 more changesShow less
    • Start date: Sep 1, 2023 to May 1, 2024
    • Study description expanded, about 121 words
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05889507
Lead Sponsor Imperial College London
Conditions Neonatal Encephalopathy, Newborn Asphyxia
Enrollment 426 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov