临床试验/NCT03852641

NCT03852641Unknown不适用

Feeding Very-low-birth-weight (VLBW) Premature Infants (<1500g) During Non-invasive Respiratory Support- Continuous Drip Vs. Bolus Gavage Feeding

Rambam Health Care Campus1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2017年10月1日最近更新: 2019年2月25日

适应症

干预措施

试验速览

阶段: 不适用
发起方: Rambam Health Care Campus
入组人数: 100
试验地点: 1
主要终点: Oxygenation instability as documented by oxygen saturation histograms

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A randomized control trial comparing bolus gavage feeds to continuous feed among premature infants supported by non-invasive respiratory support

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Supportive Care
盲法: None

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Infants <1500gr, on non-invasive respiratory support
•Feeding>20 ml/kg/day

排除标准

•Major congenital malformations
•Unstable infants because of sepsis, central nervous system, cardiac or other significant morbidities
•Gastrointestinal morbidity such as spontaneous intestinal perforation (SIP) and necrotising enterocolitis (NEC).

研究组 & 干预措施

Bolus gavage feeds

Experimental

Bolus gavage feeds over 15-30 minutes

干预措施: Length of feeding (Other)

Continuous feeds

Experimental

Continuous feeds over 2.0 hrs

干预措施: Length of feeding (Other)

结局指标

主要结局

Oxygenation instability as documented by oxygen saturation histograms

时间窗: before dischatge home at an average of 40 weeks gestation

Time to full feeds (TFF) defined as full enteral gavage feeding of 150 cc/Kg/day

时间窗: before dischatge home at an average of 40 weeks gestation

次要结局

Incidence of Necrotising enterocolitis (NEC) as defined by the medical team(before dischatge home at an average of 40 weeks gestation)
Respiratory-length of respiratory support(before dischatge home at an average of 40 weeks gestation)

研究者

发起方

Rambam Health Care Campus

申办方类型

Other

责任方

Principal Investigator

主要研究者

Liron Borenstein MD

Principal investigator

Rambam Health Care Campus

研究点 (1)

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