Timing of Inguinal Hernia Repair in Premature Infants: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 338
- 试验地点
- 79
- 主要终点
- Significant adverse event (SAE) rate
研究概览
简要总结
The purpose of this study is to determine whether early (before NICU discharge) or late (55-60 weeks post-menstrual age) inguinal hernia repair is safer for premature infants who have an inguinal hernia.
详细描述
This is a randomized clinical trial comparing early versus late repair in premature infants with an inguinal hernia (IH) to determine which approach may be safer. Safety in this trial is defined as the freedom from significant adverse events, a reduction in hospital days during the study period, and normal neurodevelopmental testing at 2 years. Costs of each treatment strategy are also important and are being evaluated.
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 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant with estimated gestational age at birth of < 37 weeks, 0 days
- •In a NICU at participating site
- •Diagnosed with an IH per the pediatric surgery team
- •Parents and providers willing to randomize the infant
排除标准
- •Infant is undergoing another operative procedure and IH repair is planned as a secondary procedure (e.g. fundoplication or G tube is planned, and IH repair is considered a secondary procedure)
- •Known major congenital anomaly that impacts neurodevelopmental outcome or chromosomal abnormality
- •Family unable to return for follow up and later IH repair; or likely unable to monitor IH as outpatient
结局指标
主要结局
Significant adverse event (SAE) rate
时间窗: 9 months beyond NICU discharge
Specific significant adverse events that are either treatment related or hernia related have been defined a priori and will be assessed in both groups from randomization until 9 months after NICU discharge.
Number of hospital days
时间窗: From randomization until 9 months post NICU discharge
Total number of hospital days
次要结局
- Bayley Scales of Infant Development, 3rd Edition(22-26 months corrected age)
- Hospital costs(Enrollment through 9 months after NICU discharge)
研究者
Martin Blakely
Associate Professor of Pediatric Surgery and Pediatrics
Vanderbilt University Medical Center