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

Phase 3Active Not RecruitingNCT04702373

Carelon Research144 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

144

Conditions

Congenital Heart Disease

Interventions

passive range of motion exercise therapyOTHER

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.

Eligibility

Sex: ALLMax age: 35 Days

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

weight-for-age z-score

Time frame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first

Secondary Outcomes

length-for-age z-score

Time frame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first

head circumference-for-age z-score

Time frame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first

Neonatal Intensive Care Unit (NICU) Network 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)

Time frame: Post-operative day 21 or discharge, whichever comes first

Tests of Infant Motor Performance (TIMP)

Time frame: Time of discharge from hospital following Norwood Procedure, approximately 3-4 weeks

Tests of Infant Motor Performance (TIMP)

Time frame: 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

Data from ClinicalTrials.gov

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