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Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery

NCT03036072 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-07-13

Study results available
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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).

Conditions

  • Post-Op Complication

Interventions

OTHER

Strict normothermia

DEVICE

Delayed Rewarming

Use of the servo-controlled cooling blanket for delayed rewarming to target temperature.

Sponsors & Collaborators

  • MaineHealth

    collaborator OTHER

  • Alexa Craig

    lead OTHER

Principal Investigators

  • Alexa K Craig, MD, MSc · Assistant Professor of Pediatrics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-04-30
Completion
2019-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03036072 on ClinicalTrials.gov