Training in Exercise Activities and Motion for Growth: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 144
- 试验地点
- 20
- 主要终点
- weight-for-age z-score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 35 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
weight-for-age z-score
时间窗: 4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
weight-for-age z-score
次要结局
- 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(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(Post-operative day 21 or discharge, whichever comes first)
- DXA(4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first)
- Tests of Infant Motor Performance (TIMP)(4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first)