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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01306500
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : August 8, 2014
Information provided by (Responsible Party):
Sushma Nangia, M.D., Lady Hardinge Medical College

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.

Condition or disease Intervention/treatment Phase
Gastritis of Newborn Other Vomiting of Newborn Meconium in Amniotic Fluid Procedure: Gastric lavage Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 538 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Gastric Lavage in Preventing Feeding Problems in Late Preterm and Term Neonates Born With Meconium Stained Amniotic Fluid : A Randomized Controlled Trial
Study Start Date : March 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Gastric lavage Group
In neonates randomized to intervention Group (gastric lavage group) gastric lavage was done in the labor room after initial stabilization
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.
No Intervention: No gastric lavage
Neonates randomized to 'No gastric lavage group' will receive supportive treatment as per standard unit protocol.

Primary Outcome Measures :
  1. Feeding problems [ Time Frame: 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

Secondary Outcome Measures :
  1. Secondary meconium aspiration syndrome [ Time Frame: Till discharge from hospital ]
    Presence of tachypnea or respiratory distress in a previously well baby following vomiting.

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Ages Eligible for Study:   up to 1 Hour   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01306500

Kalawati Saran children's Hospital, Lady Hardinge Medical College
New Delhi, Delhi, India, 110001
Sponsors and Collaborators
Lady Hardinge Medical College
Principal Investigator: Sushma Nangia, MBBS, MD, DM Lady Hardinge Medical College, New Delhi, India

Responsible Party: Sushma Nangia, M.D., Dr Sushma Nangia, Professor of Pediatrics, Lady Hardinge Medical College Identifier: NCT01306500     History of Changes
Other Study ID Numbers: LHMC/035/2010/GLAM
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014

Keywords provided by Sushma Nangia, M.D., Lady Hardinge Medical College:
Gastric lavage
Meconium stained amniotic fluid
Feeding problems

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases