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 wanted to learn if passive range-of-motion (PROM) exercises could help babies with HLHS or other single right ventricle anomalies to grow better, help their brains to develop, and bones to be stronger.
Between 2021 and 2024, 10 clinical sites in North America randomized 144 eligible babies born with HLHS with a planned Norwood procedure to receive either standard care or standard care plus PROM (passive range-of-motion).
Check back soon for a summary of key study findings!
For more information, visit ClinicalTrials.gov.
Babies born with HLHS or other single RV anomalies with planned Norwood surgery
Study activities included:
• Review of baby’s medical history, feeding and nutritional history, growth measurements
• All enrolled babies received standard care. Babies randomized to the intervention arm also received ~21 days of PROM exercises following Norwood surgery
• Neurobehavior (NNNS) and motor development (TIMP) assessments performed by licensed therapists/personnel
• Bone mineral density assessment via dual energy X-ray absorptiometry (DXA) scans at select sites
• During Norwood surgery, baby’s blood and tissue samples (which would have been otherwise discarded) were collected for genetic testing and biobanking
• Optional blood or saliva samples were collected from babies’ biological parents for genetic testing and biobanking.
• Monthly check-ins up to the Glenn surgery, typically around 4 months after the Norwood procedure.
Results of this study are currently being analyzed. Please check back for a summary of key findings and publications. The PHN is grateful to all of the families who participated in this study.
L. M. Lambert, International Journal of Cardiology. 2022 Jul 15;359:28-34.
Babies who get a Norwood procedure for hypoplastic left heart syndrome or other single right ventricle anomalies will receive either a daily passive range of motion exercise program combined with the regular care they get at the hospital or only the standard of care from their hospital. This study will see if there are differences in how the babies in each group move, respond and develop as measured by specific tests done after they receive the 21 days of the exercise program or standard care. At the time of their Stage II (Glenn) babies in both groups will again have specific tests done and also receive a bone mineral density test and we will see if there are any differences between the groups. This article describes the design, the participants and the procedures for this trial.