Training in Exercise Activities and Motion for Growth: A Randomized Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Congenital Heart Disease
- Sponsor
- Carelon Research
- Enrollment
- 144
- Locations
- 10
- Primary Endpoint
- weight-for-age z-score
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
This is a Phase III randomized controlled trial of a passive ROM exercise program that will be performed in infants with HLHS and other single right ventricle anomalies following the Norwood procedure at PHN and Auxiliary Centers.
Detailed Description
Growth is often impaired in infants with congenital heart disease (CHD). Nutritional interventions, drug therapy and surgical palliation have had varying degrees of success in enhancing growth. Passive ROM has improved somatic growth in preterm infants and has been demonstrated in a previous Pediatric Heart Network (PHN) to be safe and feasible in neonate's post-Norwood procedure. Improved growth may also favorably impact neurodevelopment, behavioral state, and time to hospital discharge. This study's objectives are to evaluate growth in infants with hypoplastic left heart syndrome (HLHS) or other single right ventricle (RV) anomalies after the Norwood procedure who are randomized to a passive range of motion (ROM) exercise program vs. standard of care.
Investigators
Eligibility Criteria
Inclusion Criteria
- •hospitalized infants with HLHS or other single RV anomalies
- •\>=37 weeks gestation
- •\<=35 days of age
- •planned Norwood procedure (or hybrid leading to Norwood within 35 days)
- •parent or guardian willing to comply with protocol and provide written informed consent
Exclusion Criteria
- •birthweight \<3rd percentile for gestational age
- •chromosomal or recognizable phenotypic syndrome of non-cardiac congenital abnormalities associated with growth failure (for example Trisomy, Noonan, or Turner syndromes)
- •non-cardiac diagnosis associated with growth failures
- •listed for cardiac transplant
- •anticipated discharge within 14 days of screening
Outcomes
Primary Outcomes
weight-for-age z-score
Time Frame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
weight-for-age z-score
Secondary Outcomes
- length-for-age z-score(4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first)
- head circumference-for-age z-score(4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first)
- Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) subdomain scores(Post-operative day 21 or discharge, whichever comes first)
- DXA(4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first)
- Tests of Infant Motor Performance (TIMP)(4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first)