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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.

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
NameTimeMethod
weight-for-age z-score4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first

weight-for-age z-score

Secondary Outcome Measures
NameTimeMethod
length-for-age z-score4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first

length-for-age z-score

head circumference-for-age z-score4 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 scoresPost-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)

DXA4 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

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

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