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
Min Age
N/A
Max Age
29 Days
Download Date
July 3, 2023
Principal Investigator
N/A
Primary Contact Information
Jessica E Teng, MPH
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: