Status:
ACTIVE_NOT_RECRUITING
Training in Exercise Activities and Motion for Growth (TEAM 4 Growth) RCT
Lead Sponsor:
Carelon Research
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
Up to 35 years
Phase:
PHASE3
Brief 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...
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. Passiv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04702373
Start Date
February 23 2021
End Date
December 30 2024
Last Update
July 3 2024
Active Locations (10)
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1
Children's Healthcare of Atlanta / Emory University
Atlanta, Georgia, United States, 30322
2
Riley Children's Hospital of Indiana
Indianapolis, Indiana, United States, 46208
3
Boston Children's Hospital
Boston, Massachusetts, United States, 02458
4
University of Michigan
Ann Arbor, Michigan, United States, 48109