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Effect of Gastric Lavage in Preventing Feeding Problems in Babies Born With Meconium Stained Amniotic Fluid

NCT01306500 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 538

Last updated 2014-08-08

No results posted yet for this study

Summary

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.

Conditions

  • Gastritis of Newborn
  • Other Vomiting of Newborn
  • Meconium in Amniotic Fluid

Interventions

PROCEDURE

Gastric lavage

8 Fr feeding tube was inserted orally with length equal to distance from the bridge of the nose to the earlobe and from the earlobe to a point halfway between the xiphoid process and the umbilicus. 20ml normal saline was used for gastric lavage. It was ensured that entire amount of normal saline used was removed from stomach.

Sponsors & Collaborators

  • Lady Hardinge Medical College

    lead OTHER_GOV

Principal Investigators

  • Sushma Nangia, MBBS, MD, DM · Lady Hardinge Medical College, New Delhi, India

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Minutes
Max Age
1 Hour
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-09-30
Completion
2010-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01306500 on ClinicalTrials.gov