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Active, Not Recruiting

NCT Number: NCT04702373

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Hypoplastic Left Heart Syndrome

Age range

Up to 35 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Hospital For Sick Children, Toronto, OT, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

passive range of motion exercise therapy

Other

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.

Primary outcomes

  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 outcomes

  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. Neonatal Intensive Care Unit (NICU) Network 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

Sponsors and collaborators

Lead sponsor

Carelon Research

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Training in Exercise Activities and Motion for Growth: A Randomized Clinical Trial

Acronym: T4G RCT

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 8, 2021
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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