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Effect Of Intrapartum Oropharyngeal (IP-OP) Suction on Meconium Aspiration Syndrome

NCT01328483 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2015-09-29

No results posted yet for this study

Summary

The purpose of the study is to evaluate the role of routine suctioning of the oropharynx before the delivery of shoulders in preventing breathing difficulty and subsequent lung disease in babies born through meconium stained amniotic fluid. Normally babies do not pass meconium while in utero. In response to hypoxic stress babies may pass meconium before birth and are likely to be candidates for problems related to meconium passage and its inhalation leading to meconium aspiration syndrome(MAS). It is believed that clearing the airways of meconium at the time of birth can decrease the risk of MAS. It had been a routine practice to suction the mouth, pharynx and nose of the baby as soon as the head of the infant is delivered prior to delivery of the shoulders followed by tracheal intubation and suction in babies with poor breathing efforts to clear the airways of the meconium. however recent studies have shown the futility of this procedure in preventing MAS along with an increased risk of complications to baby due to suctioning. In view of the uncertainty regarding the effectiveness of this procedure in a resource poor country, the investigators decided to evaluate the effect of intrapartum-oropharyngeal suction in preventing or decreasing the incidence of MAS in such babies.

Conditions

  • Meconium Aspiration Syndrome

Interventions

PROCEDURE

Intrapartum Oropharyngeal Suctioning

After delivery of the head, the infant's mouth and nose were suctioned. Nose was suctioned after the mouth and throat. Oropharyngeal suctioning was performed using a 10 french suction catheter with suction pressure of 100mm Hg or De Lee's suction trap in event of electricity failure or non availability of suction machine

Sponsors & Collaborators

  • Lady Hardinge Medical College

    lead OTHER_GOV

Principal Investigators

  • Sushma Nangia, MBBS, MD, DM · Lady Hardinge Medical College, New Delhi, India

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
10 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-03-31
Completion
2009-04-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01328483 on ClinicalTrials.gov