Status:
COMPLETED
Training in Exercise Activities and Motion for Growth
Lead Sponsor:
Carelon Research
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Single Ventricle Physiology
Eligibility:
All Genders
1-30 years
Phase:
NA
Brief Summary
To determine if an exercise program of passive range of motion (ROM) is safe and feasible in infants with single ventricle (SV) physiology after their Norwood procedure.
Detailed Description
This is a non-randomized pilot study to evaluate the safety and feasibility of an exercise program in hospitalized infants with single ventricle physiology. Following the Norwood procedure, the interv...
Eligibility Criteria
Inclusion
- Hospitalized infants with SV physiology
- \>37 weeks gestation
- \<30 days of age
- Hemodynamically stable (as defined by the attending physician) after surgical or interventional palliation with closed sternum
- Parent or guardian willing to comply with protocol and provide written informed consent
Exclusion
- Intrauterine growth restriction
- Chromosomal or recognizable phenotypic syndrome of non-cardiac congenital abnormalities associated with growth failure (for example Trisomy, Noonan or Turner syndromes)
- Unstable hemodynamics as defined by the attending physician
- Non-cardiac diagnosis associated with growth failure
- Severe neurologic injury resulting from stroke or intracranial hemorrhage confirmed by head CT/ MRI or cranial ultrasound
- Anticipated discharge within 14 days of screening
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01917084
Start Date
June 1 2013
End Date
December 1 2014
Last Update
February 20 2025
Active Locations (3)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
2
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, United States, 77030
3
Utah Primary Children's Medical Center
Salt Lake City, Utah, United States, 84132