N/A
N=25
Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery
Post-Op Complication
Bottom Line
View on ClinicalTrials.gov: NCT03036072 ↗Enrolled (actual)
25
Serious AEs
22.7%
Results posted
Apr 2020
Primary outcome: Primary: Infants With Elevated s100b and NSE — 11; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Strict normothermia (Other); Delayed Rewarming (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Alexa Craig
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Infants With Elevated s100b and NSE |
11; 9 | — |
| SECONDARY Number of Participants With Adverse Events |
3; 3 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Concern for underlying coagulation disorder such as hemophilia
- Death in the operating room
- Inability to wean of cardiopulmonary bypass at conclusion of surgery
Data sourced from ClinicalTrials.gov (NCT03036072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.