Training in Exercise Activities and Motion for Growth (TEAM 4 Growth) RCT (T4G RCT)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Other: passive range of motion exercise therapy

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 Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • OT
    • Toronto, OT, Canada, M5G1X8
      • The Hospital for Sick Children
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta / Emory University
  • Indiana
    • Indianapolis, Indiana, United States, 46208
      • Riley Children's Hospital of Indiana
  • Massachusetts
    • Boston, Massachusetts, United States, 02458
      • Boston Children's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Cincinnati Children's Hospital Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19083
      • Children's Hospital of Philadelphia
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital / Baylor
  • Utah
    • Salt Lake City, Utah, United States, 84116
      • Primary Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Passive range-of-motion; 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; 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.
No Intervention: Standard of care; standard of care at study site

What is the study measuring?

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
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
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)	Post-operative day 21 or discharge, whichever comes first

Collaborators and Investigators

• Sponsor: Carelon Research
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Norwood; hypoplastic left heart syndrome; single right ventricle; passive range-of-motion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: PHN T4G RCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No