Training in Exercise Activities and Motion for Growth (TEAM 4 Growth) RCT
- Conditions
- Congenital Heart Disease
- Interventions
- Other: passive range of motion exercise therapy
- Registration Number
- NCT04702373
- Lead Sponsor
- Carelon Research
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 144
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Passive range-of-motion passive range of motion exercise therapy daily assisted exercise sessions lasting 15-20 minutes, conducted by trained physical therapists, for up to 21 days prior to hospital discharge, plus standard of care
- Primary Outcome Measures
Name Time Method weight-for-age z-score 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first weight-for-age z-score
- Secondary Outcome Measures
Name Time Method length-for-age z-score 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first length-for-age z-score
head circumference-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
Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) subdomain scores Post-operative day 21 or discharge, whichever comes first NNNS subdomain scores; some score ranges from 1-9, but depends on each score whether higher is good or bad--for example, higher attention score is good, higher stress abstinence is bad; the rest of the scores range from 0-1 (yes/no)
DXA 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first bone mineral density as measured by dual-energy X-ray absorptiometry (DXA) scan
Tests of Infant Motor Performance (TIMP) 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first Tests of Infant Motor Performance (TIMP)
Trial Locations
- Locations (10)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Texas Children's Hospital / Baylor
🇺🇸Houston, Texas, United States
Primary Children's Hospital
🇺🇸Salt Lake City, Utah, United States
The Hospital For Sick Children
🇨🇦Toronto, OT, Canada
Riley Children's Hospital of Indiana
🇺🇸Indianapolis, Indiana, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Children's Healthcare of Atlanta / Emory University
🇺🇸Atlanta, Georgia, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States