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Training in Exercise Activities and Motion for Growth (TEAM 4 Growth) RCT (T4G RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04702373
Recruitment Status : Recruiting
First Posted : January 8, 2021
Last Update Posted : August 3, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
HealthCore-NERI

Study Description
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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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Other: passive range of motion exercise therapy Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Training in Exercise Activities and Motion for Growth: A Randomized Clinical Trial
Actual Study Start Date : February 23, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
No Intervention: Standard of care
standard of care at study site


Outcome Measures
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Primary Outcome Measures :
  1. weight-for-age z-score [ Time Frame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first ]
    weight-for-age z-score


Secondary Outcome Measures :
  1. length-for-age z-score [ Time Frame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first ]
    length-for-age z-score

  2. head circumference-for-age z-score [ Time Frame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first ]
    head circumference-for-age z-score

  3. NICU Neonatal Neurobehavioral Scale (NNNS) subdomain scores [ Time Frame: Post-operative day 21 or discharge, whichever comes first ]
    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) [ Time Frame: Time of discharge from hospital following Norwood Procedure, approximately 3-4 weeks ]
    Tests of Infant Motor Performance (TIMP)

  5. Tests of Infant Motor Performance (TIMP) [ Time Frame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first ]
    Tests of Infant Motor Performance (TIMP)

  6. DXA [ Time Frame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first ]
    bone mineral density as measured by dual-energy X-ray absorptiometry (DXA) scan


Eligibility Criteria
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Ages Eligible for Study:   up to 29 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04702373


Contacts
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Contact: Julie Miller 617-923-7747 jmiller@healthcore.com
Contact: Jessica E Teng, MPH jteng@healthcore.com

Locations
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United States, Georgia
Children's Healthcare of Atlanta / Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Shanelle Clark    404-256-2593    clarkes@kidsheart.com   
United States, Indiana
Riley Children's Hospital of Indiana Recruiting
Indianapolis, Indiana, United States, 46208
Contact: Jessica Riggins, NP    317-773-3039    jriggins@iuhealth.org   
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02458
Contact: Samantha Butler, PhD    617-355-7483    Samantha.Butler@childrens.harvard.edu   
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Karen Uzark, PhD, CPNP    734-615-9748    karenu@med.umich.edu   
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45227
Contact: Lindsey Justice, DNP, RN    513-636-6267    lindsey.justice@cchmc.org   
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19083
Contact: Donna Sylvester, BSN, BA    484-354-5385    sylvesterd@email.chop.edu   
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Frances Woodard, PNP    843-792-3292    klinefl@musc.edu   
United States, Texas
Texas Children's Hospital / Baylor Recruiting
Houston, Texas, United States, 77030
Contact: Rocky Tsang, MD    832-826-6251    rxtsang@texaschildrens.org   
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84116
Contact: Linda Lambert, MSN-cFNP    801-587-7523    linda.lambert@hsc.utah.edu   
Canada, OT
The Hospital For Sick Children Not yet recruiting
Toronto, OT, Canada, M5G1X8
Contact: Jessica Bainton, JB, RN    (416) 813-7616    jessica.bainton@sickkids.ca   
Contact: Joelene Huber, MD    (416) 813-7616    joelene.huber@sickkids.ca   
Sponsors and Collaborators
HealthCore-NERI
National Heart, Lung, and Blood Institute (NHLBI)
More Information
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Responsible Party: HealthCore-NERI
ClinicalTrials.gov Identifier: NCT04702373    
Other Study ID Numbers: PHN T4G RCT
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HealthCore-NERI:
Norwood
hypoplastic left heart syndrome
single right ventricle
passive range-of-motion
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities