A Phase 3 interventional study of passive range of motion exercise therapy in Congenital Heart Disease, sponsored by Carelon Research. Active, not recruiting at 10 sites in 2 countries. Open to participants aged Up to 35 Days. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Carelon Research · Phase 3, Interventional, and Treatment
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.
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 144 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Carelon Research is the lead sponsor of 55 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
standard of care at study site
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.
weight-for-age z-score
weight-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
length-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
head circumference-for-age z-score
Time frame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) subdomain scores
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)
Time frame: Post-operative day 21 or discharge, whichever comes first
Tests of Infant Motor Performance (TIMP)
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)
Tests of Infant Motor Performance (TIMP)
Time frame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
DXA
bone mineral density as measured by dual-energy X-ray absorptiometry (DXA) scan
Time frame: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Carelon Research