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

Congenital Heart Disease Clinical Trial

— T4G RCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04702373
• Other study ID #: PHN T4G RCT
• Status: Recruiting
• Phase: Phase 3
• Start date: February 23, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: HealthCore-NERI
• Contact: Julie Miller
• Phone: 617-923-7747
• Email: julie.miller2[@]carelon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 238
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 29 Days

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hospital For Sick Children	Toronto	OT
United States	University of Michigan	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta / Emory University	Atlanta	Georgia
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Texas Children's Hospital / Baylor	Houston	Texas
United States	Riley Children's Hospital of Indiana	Indianapolis	Indiana
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Primary Children's Hospital	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
HealthCore-NERI	National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Tests of Infant Motor Performance (TIMP)	Tests of Infant Motor Performance (TIMP)	Time of discharge from hospital following Norwood Procedure, approximately 3-4 weeks
Secondary	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
Secondary	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