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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00000470
Other study ID # 59
Secondary ID R01HL041786
Status Completed
Phase Phase 3
First received October 27, 1999
Last updated July 28, 2016
Start date December 1988
Est. completion date October 1993

Study information

Verified date July 2016
Source Children's Hospital Boston
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

To compare the influence of two surgical anesthetic techniques, hypothermia with circulatory arrest or hypothermia with low-flow bypass perfusion, on neurologic functioning in infants undergoing heart surgery.


Description:

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Recruitment information / eligibility

Status Completed
Enrollment 171
Est. completion date October 1993
Est. primary completion date February 1992
Accepts healthy volunteers No
Gender Both
Age group N/A to 1 Year
Eligibility Boy and girl infants, up to three months of age, with transposition of the great arteries with or without septal defect.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment


Intervention

Procedure:
cardiac surgical procedures

cardiopulmonary bypass


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital Boston National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (34)

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