Cooling Therapy for Neonatal Encephalopathy
(COMET Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen bySudhin Thayyil, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Thayyil, Sudhin

No Placebo Group

Trial Summary

What is the purpose of this trial?

Phase II randomised control trial of whole body cooling in mild neonatal encephalopathy.

Eligibility Criteria

This trial is for newborns under six hours old with mild brain injury due to lack of oxygen during birth. They must show signs like poor blood acidity or need for resuscitation. Babies with more severe conditions, seizures, certain brain activity patterns, or life-threatening birth defects can't join.

Inclusion Criteria

There is evidence that the baby had trouble breathing around the time of birth.

This criterion seems to be incorrectly phrased for clinical trials involving human participants, as it suggests an age of less than six hours. It might be intended for studies involving cells, animals, or in a very specific context not applicable to general human clinical trials. Could you please clarify or provide additional context?

The acidity level in your blood is too high at the time of birth.

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Exclusion Criteria

Infants without brain disease

My baby has had seizures.

Babies with significant abnormal brain activity on aEEG voltage criteria.

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Treatment Details

Interventions

Therapeutic hypothermia (Other)

Trial OverviewThe study tests how effective whole body cooling (therapeutic hypothermia) is in treating mild neonatal encephalopathy—a condition affecting the baby's brain caused by oxygen deprivation at birth.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Therapeutic hypothermia - 72 hExperimental Treatment1 Intervention

Whole body cooling (33 to 34 C) for 72 hours

Group II: Therapeutic hypothermia - 48 hExperimental Treatment1 Intervention

Whole body cooling (33 to 34 C) for 48 hours

Group III: Usual careActive Control1 Intervention

Usual care (normothermia) arm