Congenital Heart Disease
Conditions
Keywords
Norwood, hypoplastic left heart syndrome, single right ventricle, passive range-of-motion
Brief summary
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.
Detailed description
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.
Interventions
OTHERpassive range of motion exercise therapy
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Carelon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 35 Days
Healthy volunteers
No
Inclusion criteria
* hospitalized infants with HLHS or other single RV anomalies * \>=37 weeks gestation * \<=35 days of age * planned Norwood procedure (or hybrid leading to Norwood within 35 days) * parent or guardian willing to comply with protocol and provide written informed consent
Exclusion criteria
* birthweight \<3rd percentile for gestational age * chromosomal or recognizable phenotypic syndrome of non-cardiac congenital abnormalities associated with growth failure (for example Trisomy, Noonan, or Turner syndromes) * non-cardiac diagnosis associated with growth failures * listed for cardiac transplant * anticipated discharge within 14 days of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| weight-for-age z-score | 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first | weight-for-age z-score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| length-for-age z-score | 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first | length-for-age z-score |
| head circumference-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 |
| Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) subdomain scores | Post-operative day 21 or discharge, whichever comes first | 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) |
| Tests of Infant Motor Performance (TIMP) | Time of discharge from hospital following Norwood Procedure, approximately 3-4 weeks | Tests of Infant Motor Performance (TIMP) |
| DXA | 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first | bone mineral density as measured by dual-energy X-ray absorptiometry (DXA) scan |
Countries
Canada, United States
Outcome results
None listed