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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Passive range-of-motion | Experimental | 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 |
|
| Standard of care | No Intervention | standard of care at study site |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| weight-for-age z-score | weight-for-age z-score | 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| length-for-age z-score | length-for-age z-score | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta / Emory University | Atlanta | Georgia | 30322 | United States | ||
| Riley Children's Hospital of Indiana |
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|
| 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) | Post-operative day 21 or discharge, whichever comes first |
| Tests of Infant Motor Performance (TIMP) | Tests of Infant Motor Performance (TIMP) | Time of discharge from hospital following Norwood Procedure, approximately 3-4 weeks |
| Tests of Infant Motor Performance (TIMP) | Tests of Infant Motor Performance (TIMP) | 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 | 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first |
| Indianapolis |
| Indiana |
| 46208 |
| United States |
| Boston Children's Hospital | Boston | Massachusetts | 02458 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45227 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19083 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Texas Children's Hospital / Baylor | Houston | Texas | 77030 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84116 | United States |
| The Hospital For Sick Children | Toronto | OT | M5G1X8 | Canada |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018636 | Hypoplastic Left Heart Syndrome |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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