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

Phase 3

Active, not recruiting

• Conditions: Congenital Heart Disease

• 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.

Study Timeline

• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-08
• Study Start: 2021-02-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

Children's Healthcare of Atlanta / Emory University; 🇺🇸 Atlanta, Georgia, United States

Riley Children's Hospital of Indiana; 🇺🇸 Indianapolis, Indiana, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, 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