The GAIN Study: The Gastroschisis And Early Infant Nutrition Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility of Enrollment in Early Feeding Study Cohort
研究概览
简要总结
This study aims to evaluate the feasibility of initiating early feeds in neonates with gastroschisis, a condition where infants are born with their intestines outside the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates with presumed simple gastroschisis
- •Born at ≥ 34 weeks' gestation
- •Hemodynamically stable
- •Consented within 48 hours after abdominal closure
- •Mothers who are ≥16 years old
- •Mothers who speak English or Spanish
排除标准
- •Neonates with evidence of complex gastroschisis at time of closure (any ischemic bowel, intestinal perforation, or obvious atresia with mesenteric defect)
- •Presence of any major congenital anomalies
- •Neonates who are receiving ionotropic medications
- •Neonates who are wards of the state
- •Neonates whose care is considered to be futile or those undergoing re-direction of care
- •Neonates participating in another interventional trial
- •Any patient deemed unfit for participation by study investigator(s)
研究组 & 干预措施
Early Feeding Protocol Group
This arm involves neonates with presumed simple gastroschisis who will be subjected to an early feeding protocol. The protocol specifies initiating human milk feeds within 48 hours of surgical repair of gastroschisis. Feeds are advanced based on tolerance and clinical assessment, with a focus on promoting oral motor skill development.
干预措施: Early Feeding Protocol (Procedure)
结局指标
主要结局
Feasibility of Enrollment in Early Feeding Study Cohort
时间窗: From prenatal period within the first 24 hours of abdominal closure
Proportion of eligible neonates with gastroschisis whose parents/guardians consent to enrollment in the study.
次要结局
- Feasibility of Protocol Adherence(From abdominal closure to 48 hours after closure.)
- Fidelity to Protocol(From abdominal closure through discharge from the hospital, average of 90 days)
- Protocol Withdrawal Rate(From time of enrollment (prenatal) to hospital discharge, an average of 90 days)