Training in Exercise Activities and Motion for Growth

Completed · Not applicable

Conditions studied: Single Ventricle Physiology

In brief

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.

Key facts

Study ID

NCT01917084

Run by

Carelon Research

People needed

20

Starts

2013-06-01

Expected to finish

2014-12-01

Last updated by the study team

2025-02-20

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Baylor College of Medicine - Texas Children's Hospital — Houston, Texas, United States
• Utah Primary Children's Medical Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.