Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery
2 other identifiers
interventional
25
1 country
1
Brief Summary
This is an unblinded, single center, randomized study of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, randomized to either the delayed rewarming intervention or to the standard of care (strict normothermia).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 24, 2017
CompletedFirst Posted
Study publicly available on registry
January 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedResults Posted
Study results publicly available
April 15, 2020
CompletedJuly 13, 2020
April 1, 2020
1.9 years
January 24, 2017
April 3, 2020
June 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infants With Elevated s100b and NSE
In a population of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, does delayed rewarming administered during the 12 hours after surgery, compared to standard care, decrease brain injury as measured by levels of serum biomarkers of brain injury, s100b and neuron specific enolase during the four days after surgery?
4 days
Secondary Outcomes (1)
Number of Participants With Adverse Events
4 days
Study Arms (2)
Strict Normothermia
ACTIVE COMPARATORPatients will be rewarmed to 36.5 degrees centigrade in the operating room and maintained here by conventional means in the PICU.
Delayed Rewarming
EXPERIMENTALPatient will be rewarmed to 35.0 degrees centigrade in the operating room, then slowly rewarmed to normal physiologic temperature over 12 hours by using a servo-controlled cooling blanket. Normothermia will be maintained by the cooling blanket for an additional 12 hours.
Interventions
Use of the servo-controlled cooling blanket for delayed rewarming to target temperature.
Eligibility Criteria
You may qualify if:
- Diagnosis of congenital heart disease requiring congenital heart surgery on bypass
- Age less than 6 months at the time of surgery
- Intra-operative hypothermia less than or equal to 35°C
You may not qualify if:
- Concern for underlying coagulation disorder such as hemophilia
- Death in the operating room
- Inability to wean of cardiopulmonary bypass at conclusion of surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alexa Craiglead
- MaineHealthcollaborator
Study Sites (1)
Maine Medical Center
Portland, Maine, 04102, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alexa Craig, MD
- Organization
- Maine Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Alexa K Craig, MD, MSc
Assistant Professor of Pediatrics
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics
Study Record Dates
First Submitted
January 24, 2017
First Posted
January 30, 2017
Study Start
May 1, 2016
Primary Completion
April 1, 2018
Study Completion
May 1, 2019
Last Updated
July 13, 2020
Results First Posted
April 15, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share