TEAM 4 Growth RCT

(Completed Recruiting)

About This Study

Training in Exercise Activities and Motion for Growth (TEAM 4 Growth) RCT - The purpose of this study is to learn whether passive range-of-motion exercises can help babies with Hypoplastic Left Heart Syndrome or other single right ventricle anomalies grow better, help their brains develop, and bones be stronger.

Study Locations

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Study Details

Babies born with complex heart defects like Hypoplastic Left Heart Syndrome (HLHS) often experience slowed growth and development after their Norwood surgery. In this research study, we want to learn if passive range-of-motion (ROM) exercises can help babies with HLHS or other single right ventricle anomalies to grow better, help their brains to develop, and bones to be stronger. The passive ROM exercises are performed by a trained therapist and involve moving the baby’s arms, legs, shoulders and hips through a series of gentle exercises. We will compare babies who receive the ROM exercise to those who receive standard of care.

Babies up to 29 days old born with HLHS or other single RV anomalies, with a planned Norwood procedure.

Before the Norwood Surgery, the study will be explained to you in detail by one of the study investigators. Once your questions have been answered, you will be asked to sign an informed consent form to enter the study.

During the Norwood Surgery we will collect a blood and tissue sample from your baby, and collect an optional blood/saliva sample from the baby’s biological mother and father.

After the Norwood Surgery we will:

  • Randomize your baby to the passive Range of Motion exercise group or to the standard of care group
  • Provide Standard of Care, which may include handling, cuddling, physical, occupational, and/or speech therapies OR provide the intervention, Passive Range of Motion, which includes all of the Standard of Care plus 15-20 minutes of gentle exercise each day from a trained expert familiar with handling babies who have had heard surgery
  • Collect medical history
  • Weigh and Measure your baby at approximately 4-5 time points
  • Complete neurobehavior and motor development tests
  • Contact you each month to check on your baby’s progress, feeding, readmissions and overall health
  • Invite you to complete a final study visit when your baby is 4 months old, which will include collecting information about your baby’s progress, a motor development test, and a bone mineral density (DXA) scan.

Your baby will be in this study for about 4 months.

We cannot promise any benefit to your baby for taking part in this research. When we finish the study, we hope to know more about growth in babies with HLHS and other single RV anomalies. This may help other babies born with heart defects in the future.

The possible risks of participating in this study include:

  • Your baby experiencing agitation, changes in heart rate or breathing while being handled. For babies assigned to the Passive ROM group, the exercises may be stopped and resumed at a later time if agitation or changes in heart rate or breathing are observed.
  • The DXA scan involves exposure to a small amount of radiation
  • Loss of confidentiality
  • Genetic testing/analysis

We will tell you about any new information that may affect your or your child’s health, welfare, or choice to stay in the research.

There will be no extra costs to you if your child is in the study. Your insurance will not be billed for any research-only activities. You are responsible for costs related to your baby’s normal medical care.