Effect of Gastric Lavage in Preventing Feeding Problems in Babies Born With Meconium Stained Amniotic Fluid (GLAM)
|ClinicalTrials.gov Identifier: NCT01306500|
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : August 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Gastritis of Newborn Other Vomiting of Newborn Meconium in Amniotic Fluid||Procedure: Gastric lavage||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Feeding problems [ Time Frame: Till discharge from hospital ]
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 meconium aspiration syndrome [ Time Frame: Till discharge from hospital ]Presence of tachypnea or respiratory distress in a previously well baby following vomiting.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306500
|Kalawati Saran children's Hospital, Lady Hardinge Medical College|
|New Delhi, Delhi, India, 110001|
|Principal Investigator:||Sushma Nangia, MBBS, MD, DM||Lady Hardinge Medical College, New Delhi, India|