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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified June 2024 by Carelon Research
Sponsor
Carelon Research
Information Provided by (Responsible Party)
Carelon Research
Clinicaltrials.gov Identifier
NCT04702373
Other Study ID Numbers:
PHN T4G RCT
First Submitted
December 2, 2020
First Posted
January 7, 2021
Last Update Posted
July 2, 2024
Last Verified
June 2024

ClinicalTrials.gov processed this data on July 2024. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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.

Condition or DiseaseIntervention/Treatment
Congenital Heart Disease
Other: passive range of motion exercise therapy

Study Design

Study TypeInterventional
Actual Enrollment144 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleTraining in Exercise Activities and Motion for Growth: A Randomized Clinical Trial
Study Start DateFebruary 22, 2021
Actual Primary Completion DateNovember 29, 2024
Actual Study Completion DateDecember 29, 2024

Groups and Cohorts

Group/CohortIntervention/Treatment
Passive range-of-motion
daily assisted exercise sessions lasting 15-20 minutes, conducted by trained physical therapists, for up to 21 days prior to hospital discharge, plus standard of care
Other: passive range of motion exercise therapy
Systematic flexion-extension with gentle compression at the end of the movement is performed 10 times at the wrist, elbow, shoulder, ankle, knee, and hip joints. Ten repetitions of adduction-abduction are performed at the shoulder and hip joints.
Standard of care
standard of care at study site

Outcome Measures

Primary Outcome Measures
  1. weight-for-age z-score
    weight-for-age z-score
Secondary Outcome Measures
  1. length-for-age z-score
    length-for-age z-score
  2. head circumference-for-age z-score
    head circumference-for-age z-score
  3. Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) subdomain scores
    NNNS subdomain scores; some score ranges from 1-9, but depends on each score whether higher is good or bad--for example, higher attention score is good, higher stress abstinence is bad; the rest of the scores range from 0-1 (yes/no)
  4. Tests of Infant Motor Performance (TIMP)
    Tests of Infant Motor Performance (TIMP)
  5. Tests of Infant Motor Performance (TIMP)
    Tests of Infant Motor Performance (TIMP)
  6. DXA
    bone mineral density as measured by dual-energy X-ray absorptiometry (DXA) scan

Eligibility Criteria

Ages Eligible for Study(Child)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsCarelon Research
Locations
Children's Healthcare of Atlanta / Emory University | Atlanta Georgia, United States, 30322Riley Children's Hospital of Indiana | Indianapolis Indiana, United States, 46208Boston Children's Hospital | Boston Massachusetts, United States, 02458University of Michigan | Ann Arbor Michigan, United States, 48109Cincinnati Children's Hospital Medical Center | Cincinnati Ohio, United States, 45227Children's Hospital of Philadelphia | Philadelphia Pennsylvania, United States, 19083Medical University of South Carolina | Charleston South Carolina, United States, 29425Texas Children's Hospital / Baylor | Houston Texas, United States, 77030Primary Children's Hospital | Salt Lake City Utah, United States, 84116The Hospital For Sick Children | Toronto OT, Canada, M5G1X8