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

NCT01306500 | Completed DMC

• 1 other identifier: LHMC/035/2010/GLAM
• Study Type: interventional
• Target: 538
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gastric lavage; Neonate; Meconium stained amniotic fluid; Feeding problems

Outcome Measures

Primary Outcomes (1)

• Feeding problems

  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

  Till discharge from hospital

Secondary Outcomes (1)

• Secondary meconium aspiration syndrome

  Till discharge from hospital

Study Arms (2)

Gastric lavage Group

EXPERIMENTAL

In neonates randomized to intervention Group (gastric lavage group) gastric lavage was done in the labor room after initial stabilization

Procedure: Gastric lavage

No gastric lavage

NO INTERVENTION

Neonates randomized to 'No gastric lavage group' will receive supportive treatment as per standard unit protocol.

Interventions

Gastric lavage PROCEDURE

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.

Gastric lavage Group

Eligibility Criteria

• Age: 2 Minutes - 1 Hour
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

Study Sites (1)

Kalawati Saran children's Hospital, Lady Hardinge Medical College

New Delhi, National Capital Territory of Delhi, 110001, India

Location

MeSH Terms

Interventions

Gastric Lavage

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Study Officials

• Sushma Nangia, MBBS, MD, DM

  Lady Hardinge Medical College, New Delhi, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Sushma Nangia, Professor of Pediatrics

Study Record Dates

• First Submitted: March 1, 2011
• First Posted: March 2, 2011
• Study Start: March 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 8, 2014

Record last verified: 2014-08

Locations

IN (1)