At a glance
ClinicalIndex Comparison RecordN/ACompleted· 25 enrolled
Drug / intervention
Strict normothermia +1 moreother
Likely dose
Not stated in record
Key inclusion· 3
- ✓Diagnosis of congenital heart disease requiring congenital heart surgery on bypass
- ✓Age less than 6 months at the time of surgery
- ✓Intra-operative hypothermia at or below 35°C
Key exclusion· 3
- ✕Concern for underlying coagulation disorder such as hemophilia
- ✕Death in the operating room
- ✕Inability to wean off cardiopulmonary bypass at conclusion of surgery
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery
In Brief
A clinical study evaluating Strict normothermia and Delayed Rewarming for Post-Op Complication. Completed, enrolled 25 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-Op Complication
CountriesUnited States
CollaboratorsMaineHealth
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
Enrollment StartMay 2016
First PostedJan 2017
Primary CompletionApr 2018
Study CompletionMay 2019
TodayJul 2026
First PostedJan 30, 2017
Enrollment StartMay 1, 2016
Primary CompletionApr 1, 2018
Study CompletionMay 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.4 years ago
Interventions
Strict normothermiaother
Delayed Rewarmingdevice
Use of the servo-controlled cooling blanket for delayed rewarming to target temperature.