Effect of Standardised vs Local Preoperative Enteral Feeding Practice on the Incidence of NEC in Infants With Duct Dependent Lesions: a Randomised Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 384
- 试验地点
- 2
- 主要终点
- Proportion of death
研究概览
简要总结
This is a multicenter randomised controlled trial to assess whether standardised enteral feeding in newborns with duct dependenty congenital heart disease decreases the risk of necrotising enterocolitis (NEC). The investigators plan to include a total 384 infants. The study will be carried out in three level III hospitals in Poland. The primary end will be NEC and/or death. Secondary end points include weight gain, hospital length of stay, time required to reach full feeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Minute 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duct dependent congenital heart disease
- •Term infants
- •Parental/legal guardian consent
排除标准
- •Potential contradictions to early central feeding
- •Feeding intolerance
- •Hemodynamic instability
- •> 50% formula based enteral feeding
- •Birth weight less than 2500g
研究组 & 干预措施
control group
Patients will receive enteral feeding based on the practice of the leading physician.
intervention
Infants will receive enteral feeding based on the following protocol.
Enteral nutrition Minimal enteral nutrition (MEN) will begin within 72 hours life at 10 to 20. mL/kg/day, via bolus gravity breast milk/donor human milk. MEN will not be included in the caloric goals.
Advancements in feeding will be set at 20-30 mL/kg/day, but not more than 10ml per feeding portion to reach a goal of 150ml/kg/day, but not than 120ml/kg/day cases of fluid restriction).
The goal will be to reach an overall daily caloric intake of minimum 100kcal/kg/d.
干预措施: enteral feeding as per predefined protocol (Other)
结局指标
主要结局
Proportion of death
时间窗: up to two weeks life
Death rate.
Proportion of final diagnosis of necrotizing enterocolitis (NEC).
时间窗: up to two weeks life
Number of infants diagnosed with NEC.
次要结局
- Final median value of Vasoactive support(within 4 weeks)
- Median change from baseline of protein intake(within 4 weeks)
- Proportion of number of interrupted feedings(final value within 4 weeks)
- Proportion of final value of days required to reach full enteral feeding(within 4 weeks)
- Median change from baseline of caloric intake(within 4 weeks)
- Proportion of final value of days on mechanical ventilation(within 4 weeks)
- Proportion of final value of days required to regain birth weight(within 4 weeks)
- Median change from baseline of breastfeeding of > 50%(within 12 months)
- Proportion of culture proven late onset sepsis(4 weeks)
- growth(Number of infants with a significant median change from baseline within 12 months)
研究者
Joanna Seliga-Siwecka
Principal investigator
Princess Anna Mazowiecka Hospital, Warsaw, Poland