Current Environment:

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.

Conditions

Congenital Heart Disease

Recruitment Status

Recruiting

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.

Eligibility Criteria

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

Intervention

Intervention Type

Intervention Name

Other

passive range of motion exercise therapy

Phase

Phase 3

Gender

All

Minimum Age

N/A

Maximum Age

29 Days

Download Date

July 16, 2021

Principal Investigator

N/A

Primary Contact Information

Julie Miller

617-923-7747

jmiller@healthcore.com

Jessica E Teng, MPH

jteng@healthcore.com

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: