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Cooling Therapy for Neonatal Encephalopathy (COMET Trial)
N/A
Waitlist Available
Led By Sudhin Thayyil, PhD
Research Sponsored by Thayyil, Sudhin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age less than six hours
Evidence of mild NE (at-least two abnormalities) on an NICHD neurological examination performed between 1 and 6h of birth
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 to 14 days after birth
Awards & highlights
COMET Trial Summary
This trial is testing whether whole body cooling can help babies with mild encephalopathy, which is a condition that can cause brain damage.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
While not explicitly listed here, therapeutic hypothermia may lead to side effects such as changes in heart rate, breathing issues, and infections due to the lowered body temperature used as treatment.
COMET Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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?
Select...
My newborn showed signs of mild neurological issues within 6 hours of birth.
COMET Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 to 14 days after birth
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 to 14 days after birth
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Thalamic N-acetyl aspartate level
Secondary outcome measures
Brain
Hospital stay
COMET Trial Design
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
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Who is running the clinical trial?
Thayyil, SudhinLead Sponsor
11 Previous Clinical Trials
4,475 Total Patients Enrolled
7 Trials studying Neonatal Encephalopathy
3,436 Patients Enrolled for Neonatal Encephalopathy
Wayne State UniversityOTHER
307 Previous Clinical Trials
108,324 Total Patients Enrolled
1 Trials studying Neonatal Encephalopathy
62 Patients Enrolled for Neonatal Encephalopathy
Sudhin Thayyil, PhDPrincipal InvestigatorImperial College London
4 Previous Clinical Trials
1,400 Total Patients Enrolled
3 Trials studying Neonatal Encephalopathy
896 Patients Enrolled for Neonatal Encephalopathy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- There is evidence that the baby had trouble breathing around the time of birth.Infants without brain diseaseMy baby has had seizures.Babies with significant abnormal brain activity on aEEG voltage criteria.My baby has a serious birth defect.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.My newborn showed signs of mild neurological issues within 6 hours of birth.If the baby had a difficult birth and showed signs of distress shortly after being born, they may not be able to participate in the study.My baby qualifies for cooling therapy due to severe brain injury.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care
- Group 2: Therapeutic hypothermia - 48 h
- Group 3: Therapeutic hypothermia - 72 h
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment process still ongoing for this experiment?
"According to information available on clinicaltrials.gov, this medical trial is still recruiting patients. The research was first made public on October 10th 2019 and it has been updated as recently as July 27th 2022."
Answered by AI
What is the upper bound of participants in this experiment?
"Affirmative, the information available on clinicaltrials.gov speaks to this trial actively seeking participants. The experiment was first offered on October 10th 2019 and subsequently revised on July 27th 2022. This research is recruiting 140 individuals from a single medical centre."
Answered by AI
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