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Clinical Trial 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.


Clinical Trial 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 intervention will be administered for up to 21 days or until discharge, whichever comes first. Data will be collected daily during hospitalization and at a follow-up visit at 3 months of age. Sources of data will include medical record review. Twenty subjects will be enrolled at three Pediatric Heart Network study sites (Utah Primary Children's Hospital, Children's Hospital of Philadelphia and Texas Children's Hospital). Subjects will be recruited following Institutional Review Board (IRB) approval at each institution and parental/legal guardian consent. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01917084
Study type Interventional
Source HealthCore-NERI
Contact
Status Completed
Phase N/A
Start date June 2013
Completion date December 2014

See also
  Status Clinical Trial Phase
Withdrawn NCT00156455 - Sleep Disordered Breathing in Children With Single Ventricle Physiology N/A
Recruiting NCT02995577 - Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation N/A