Clinical trial NCT01306500: Effect of Gastric Lavage in Preventing Feeding Problems in Babies Born With Meconium Stained Amniotic Fluid
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
Overall status: COMPLETED
Phase: NA
Conditions: Gastritis of Newborn
Other Vomiting of Newborn
Meconium in Amniotic Fluid
Keywords: Gastric lavage
Neonate
Meconium stained amniotic fluid
Feeding problems
Lead sponsor: Lady Hardinge Medical College
Sponsor class: OTHER_GOV
First posted: 2011-03-02
Enrollment: 538
Sex: ALL
Minimum age (years): 2
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Feeding problems
timeFrame: Till discharge from hospital
Secondary outcomes:
measure: Secondary meconium aspiration syndrome
timeFrame: Till discharge from hospital
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Kalawati Saran children's Hospital, Lady Hardinge Medical College
state: Delhi
Study officials:
affiliation: Lady Hardinge Medical College, New Delhi, India
name: Sushma Nangia, MBBS, MD, DM
role: PRINCIPAL_INVESTIGATOR
References: