Design and methods for the training in exercise activities and motion for growth (TEAM 4 growth) trial: A randomized controlled trial

Linda M. Lambert, Division of Pediatric Cardiothoracic Surgery, University of Utah, Salt Lake City, UT, United States of America. Electronic address: Linda.lambert@hsc.utah.edu.
Victoria L. Pemberton, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, United States of America.
Felicia L. Trachtenberg, HealthCore Inc., Watertown, MA, United States of America.
Karen Uzark, Division of Cardiology, C.S. Mott Children's Hospital, Ann Arbor, MI, United States of America.
Frances Woodard, Division of Pediatric Cardiology, Medical University of South Carolina, Charleston, SC, United States of America.
Jessica E. Teng, HealthCore Inc., Watertown, MA, United States of America.
Jessica Bainton, Division of Cardiology, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
Shanelle Clarke, Division of Cardiology, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, United States of America.
Lindsey Justice, Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States of America.
Marcie R. Meador, Division of Cardiology Pediatric Anesthesiology, Texas Children's Hospital, Baylor College of Medicine, Houston, TX, United States of America.
Jessica Riggins, Division of Cardiovascular Surgery, Riley Hospital for Children at IU Health, Indianapolis, IN, United States of America.
Mary Suhre, Division of Cardiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States of America.
Donna Sylvester, Division of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, Philadelphia, PA, United States of America.
Samantha Butler, Department of Psychiatry, Children's Hospital Boston, Boston, MA, United States of America.
Thomas A. Miller, Division of Cardiology, Maine Medical Center, Portland, ME, United States of America.

Document Type

Article

Publication Date

4-18-2022

Journal Title

International journal of cardiology

Abstract

BACKGROUND: Growth is often impaired in infants with congenital heart disease. Poor growth has been associated with worse neurodevelopment, abnormal behavioral state, and longer time to hospital discharge. Nutritional interventions, drug therapy, and surgical palliation have varying degrees of success enhancing growth. Passive range of motion (PROM) improves somatic growth in preterm infants and is safe and feasible in infants with hypoplastic left heart syndrome (HLHS), after their first palliative surgery (Norwood procedure). METHODS: This multicenter, Phase III randomized control trial of a 21-day PROM exercise or standard of care evaluates growth in infants with HLHS after the Norwood procedure. Growth (weight-, height- and head circumference-for-age z-scores) will be compared at 4 months of age or at the pre-superior cavopulmonary connection evaluation visit, whichever comes first. Secondary outcomes include neonatal neurobehavioral patterns, neurodevelopmental assessment, and bone mineral density. Eligibility include diagnosis of HLHS or other single right ventricle anomaly, birth at ≥37 weeks gestation and Norwood procedure at age, and family consent. Infants with known chromosomal or recognizable phenotypic syndromes associated with growth failure, listed for transplant, or expected to be discharged within 14 days of screening are excluded. CONCLUSIONS: The TEAM 4 Growth trial will make an important contribution to understanding the role of PROM on growth, neurobehavior, neurodevelopment, and BMD in infants with complex cardiac anomalies, who are at high risk for growth failure and developmental concerns.

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