Effect of Gastric Lavage in Preventing Feeding Problems in Babies Born With Meconium Stained Amniotic Fluid (GLAM)
Primary Purpose
Gastritis of Newborn, Other Vomiting of Newborn, Meconium in Amniotic Fluid
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Gastric lavage
Sponsored by
About this trial
This is an interventional prevention trial for Gastritis of Newborn focused on measuring Gastric lavage, Neonate, Meconium stained amniotic fluid, Feeding problems
Eligibility Criteria
Inclusion Criteria:
- Gestation > 34 weeks
- Meconium staining of amniotic fluid
- Vigorous babies
Exclusion Criteria:
- Major Congenital malformation
- Non vigorous babies
- Refusal of consent
Sites / Locations
- Kalawati Saran children's Hospital, Lady Hardinge Medical College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Gastric lavage Group
No gastric lavage
Arm Description
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.
Outcomes
Primary Outcome Measures
Feeding problems
Feeding problems were considered to be present
Mother or caretaker gave history of retching, vomiting or both.
Nursing staff or resident on duty observed vomiting, retching or both
Secondary Outcome Measures
Secondary meconium aspiration syndrome
Presence of tachypnea or respiratory distress in a previously well baby following vomiting.
Full Information
NCT ID
NCT01306500
First Posted
March 1, 2011
Last Updated
August 7, 2014
Sponsor
Lady Hardinge Medical College
1. Study Identification
Unique Protocol Identification Number
NCT01306500
Brief Title
Effect of Gastric Lavage in Preventing Feeding Problems in Babies Born With Meconium Stained Amniotic Fluid
Acronym
GLAM
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 Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lady Hardinge Medical College
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastritis of Newborn, Other Vomiting of Newborn, Meconium in Amniotic Fluid
Keywords
Gastric lavage, Neonate, Meconium stained amniotic fluid, Feeding problems
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
538 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gastric lavage Group
Arm Type
Experimental
Arm Description
In neonates randomized to intervention Group (gastric lavage group) gastric lavage was done in the labor room after initial stabilization
Arm Title
No gastric lavage
Arm Type
No Intervention
Arm Description
Neonates randomized to 'No gastric lavage group' will receive supportive treatment as per standard unit protocol.
Intervention Type
Procedure
Intervention Name(s)
Gastric lavage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feeding problems
Description
Feeding problems were considered to be present
Mother or caretaker gave history of retching, vomiting or both.
Nursing staff or resident on duty observed vomiting, retching or both
Time Frame
Till discharge from hospital
Secondary Outcome Measure Information:
Title
Secondary meconium aspiration syndrome
Description
Presence of tachypnea or respiratory distress in a previously well baby following vomiting.
Time Frame
Till discharge from hospital
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Minutes
Maximum Age & Unit of Time
1 Hour
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestation > 34 weeks
Meconium staining of amniotic fluid
Vigorous babies
Exclusion Criteria:
Major Congenital malformation
Non vigorous babies
Refusal of consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sushma Nangia, MBBS, MD, DM
Organizational Affiliation
Lady Hardinge Medical College, New Delhi, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kalawati Saran children's Hospital, Lady Hardinge Medical College
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110001
Country
India
12. IPD Sharing Statement
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Effect of Gastric Lavage in Preventing Feeding Problems in Babies Born With Meconium Stained Amniotic Fluid
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