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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Other: passive range of motion exercise therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hospitalized infants with HLHS or other single RV anomalies >=37 weeks gestation <30 days of age planned Norwood procedure 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

Ages Eligible for Study
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Maximum Age: 29 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Passive range-of-motion<br>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 | Other: passive range of motion exercise therapy<br>* Systematic flexion-extension with gentle compression at the end of the movement is performed 10 times at the wrist, elbow, shoulder, ankle, knee, and hip joints. Ten repetitions of adduction-abduction are performed at the shoulder and hip joints.<br>|
| No Intervention: Standard of care<br>standard of care at study site | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight-for-age z-score | weight-for-age z-score | 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length-for-age z-score | 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 | head circumference-for-age z-score | 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first | 
| NICU Neonatal Neurobehavioral Scale (NNNS) subdomain scores | 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) | Post-operative day 21 or discharge, whichever comes first | 
| Tests of Infant Motor Performance (TIMP) | Tests of Infant Motor Performance (TIMP) | Time of discharge from hospital following Norwood Procedure, approximately 3-4 weeks | 
| Tests of Infant Motor Performance (TIMP) | Tests of Infant Motor Performance (TIMP) | 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first | 
| DXA | bone mineral density as measured by dual-energy X-ray absorptiometry (DXA) scan | 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Norwood, hypoplastic left heart syndrome, single right ventricle, passive range-of-motion