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

Status unconfirmed · Phase 3

Conditions studied: Congenital Heart Disease

In brief

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.

Key facts

Study ID

NCT04702373

Run by

Carelon Research

People needed

144

Starts

2021-02-23

Expected to finish

2024-12-30

Last updated by the study team

2024-07-03

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.