NCT01306500|CompletedDMC
Effect of Gastric Lavage in Preventing Feeding Problems in Babies Born With Meconium Stained Amniotic Fluid
GLAM
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GLAM
Sponsor study identifier
interventional
538
1 country
1
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2010
Actual (reported)Study Completion
December 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2010
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
September 2010
Actual (reported)December 2010
Actual (reported)March 1, 2011
Actual (reported)March 2, 2011
Actual (reported)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 meconium aspiration syndrome
Till discharge from hospital
In neonates randomized to intervention Group (gastric lavage group) gastric lavage was done in the labor room after initial stabilization
Neonates randomized to 'No gastric lavage group' will receive supportive treatment as per standard unit protocol.
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.
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Kalawati Saran children's Hospital, Lady Hardinge Medical College
New Delhi, National Capital Territory of Delhi, 110001, India
Sushma Nangia, MBBS, MD, DM
Lady Hardinge Medical College, New Delhi, India
538 participants (actual enrollment reported by the registry).
First Submitted
March 1, 2011
First Posted
March 2, 2011
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
September 2010
Actual (reported)Study Completion
December 2010
Actual (reported)Last Updated
August 8, 2014
Record last verified: 2014-08
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Source: ClinicalTrials.gov.
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