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临床试验/NCT01306500
NCT01306500已完成不适用

Effect of Gastric Lavage in Preventing Feeding Problems in Late Preterm and Term Neonates Born With Meconium Stained Amniotic Fluid : A Randomized Controlled Trial

Lady Hardinge Medical College2 个研究点 分布在 1 个国家目标入组 538 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
538
试验地点
2
主要终点
Feeding problems

研究概览

简要总结

The purpose of the study is to evaluate the role of gastric lavage in preventing feeding problems in babies born through meconium stained amniotic fluid. It is a routine practice in many hospitals to perform gastric lavage in all babies born with meconium stained amniotic fluid after stabilisation without any supporting evidence. It is believed that meconium is an irritant and its presence in stomach causes gastritis and vomiting and hence the basis for this practice. Orogastric tube insertion and subsequent gastric lavage is not without complications. Potential complications will be prevented and health resources will be saved if this procedure is not proven to be beneficial. Therefore the investigators decided to study if gastric lavage reduces incidence of vomiting and other feeding difficulties as well as incidence of respiratory difficulties in babies born with MSAF.

详细描述

Meconium passage in newborn infants is a developmentally programmed event normally occurring within first 24-48 hours of birth. The meconium staining of amniotic fluid occurs in 12% of all live births per annuum.

The routine use of gastric lavage in MSAF babies has been advocated for a long time as a part of the conventional treatment. Meconium in stomach is hypothesized to act as an irritant and cause vomiting and retching. Surprisingly this recommendation is also made in some textbooks without supporting evidence.

Orogastric tube insertion and subsequent gastric lavage can cause complications like bradycardia, apnea, vomiting, trauma, aspiration and esophageal or gastric perforations. Some researchers have found that gastric suction done at birth is associated with long term risk for functional intestinal disorder. The sequence of prefeeding behaviour is disrupted in children who undergo gastric suction and it can delay initiation of breast feeding. Small elevation in mean arterial blood pressure, increased retching have also been reported The role of gastric lavage in preventing feeding problems and secondary meconium aspiration syndrome has not been systematically evaluated. If this procedure is not proven to be beneficial it will prevent potential complications which may arise due to it in a significant number of babies. Also in a resource limited country the cost of materials required and time of medical personnel will be saved. Hence the purpose of this prospective randomized controlled trial is to compare the incidence of feeding problems and secondary meconium aspiration syndrome, in gastric lavage group vs no lavage group.

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
None

入排标准

年龄范围
2 Minutes 至 1 Hour(Child)
性别
All
接受健康志愿者

入选标准

  • Gestation > 34 weeks
  • Meconium staining of amniotic fluid
  • Vigorous babies

排除标准

  • Major Congenital malformation
  • Non vigorous babies
  • Refusal of consent

结局指标

主要结局

Feeding problems

时间窗: Till discharge from hospital

Feeding problems were considered to be present 1. Mother or caretaker gave history of retching, vomiting or both. 2. Nursing staff or resident on duty observed vomiting, retching or both

次要结局

  • Secondary meconium aspiration syndrome(Till discharge from hospital)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sushma Nangia, M.D.

Dr Sushma Nangia, Professor of Pediatrics

Lady Hardinge Medical College

研究点 (2)

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