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Training in Exercise Activities and Motion for Growth (TEAM 4 Growth) RCT — T4G RCT  

Congenital Heart Disease Clinical Trial

Official title:
Training in Exercise Activities and Motion for Growth: A Randomized Clinical Trial

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04702373
Study type Interventional
Source HealthCore-NERI
Contact Julie Miller
Phone 617-923-7747
Email julie.miller2@carelon.com
Status Recruiting
Phase Phase 3
Start date February 23, 2021
Completion date June 30, 2024
View Details
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