Clinical trial NCT04702373: Training in Exercise Activities and Motion for Growth (TEAM 4 Growth) RCT
Official title: Training in Exercise Activities and Motion for Growth: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Congenital Heart Disease
Keywords: Norwood
hypoplastic left heart syndrome
single right ventricle
passive range-of-motion
Lead sponsor: Carelon Research
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-01-08
Enrollment: 144
Sex: ALL
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 at PHN and Auxiliary Centers.

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
* \<=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 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

Primary outcomes:
measure: weight-for-age z-score
timeFrame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
Secondary outcomes:
measure: length-for-age z-score
timeFrame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
measure: head circumference-for-age z-score
timeFrame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
measure: Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) subdomain scores
timeFrame: Post-operative day 21 or discharge, whichever comes first
measure: Tests of Infant Motor Performance (TIMP)
timeFrame: Time of discharge from hospital following Norwood Procedure, approximately 3-4 weeks
measure: Tests of Infant Motor Performance (TIMP)
timeFrame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
measure: DXA
timeFrame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta / Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Riley Children's Hospital of Indiana
state: Indiana
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Texas Children's Hospital / Baylor
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Toronto
country: Canada
facility: The Hospital For Sick Children
state: OT
Study officials:
References: