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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sushma Nangia, M.D., Lady Hardinge Medical College
ClinicalTrials.gov Identifier:
NCT01306500
First received: March 1, 2011
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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 Intervention
Gastritis of Newborn
Other Vomiting of Newborn
Meconium in Amniotic Fluid
Procedure: Gastric lavage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Lady Hardinge Medical College:

Primary Outcome Measures:
  • Feeding problems [ Time Frame: Till discharge from hospital ] [ Designated as safety issue: No ]

    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:
  • Secondary meconium aspiration syndrome [ Time Frame: Till discharge from hospital ] [ Designated as safety issue: No ]
    Presence of tachypnea or respiratory distress in a previously well baby following vomiting.


Enrollment: 538
Study Start Date: March 2010
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   up to 1 Hour
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Major Congenital malformation
  • Non vigorous babies
  • Refusal of consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306500

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

No publications provided

Responsible Party: Sushma Nangia, M.D., Dr Sushma Nangia, Professor of Pediatrics, Lady Hardinge Medical College
ClinicalTrials.gov Identifier: NCT01306500     History of Changes
Other Study ID Numbers: LHMC/035/2010/GLAM
Study First Received: March 1, 2011
Last Updated: August 7, 2014
Health Authority: India: Indian Council of Medical Research

Keywords provided by Lady Hardinge Medical College:
Gastric lavage
Neonate
Meconium stained amniotic fluid
Feeding problems

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

ClinicalTrials.gov processed this record on August 21, 2014