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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    238
  • sponsor
    HealthCore-NERI
Updated on 25 July 2021
Investigator
Julie Miller, MPH
Primary Contact
Boston Children's Hospital (5.2 mi away) Contact
+8 other location

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.

Details
Condition Congenital Heart Disease
Treatment passive range of motion exercise therapy
Clinical Study IdentifierNCT04702373
SponsorHealthCore-NERI
Last Modified on25 July 2021

Eligibility

Yes No Not Sure

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
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