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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Role of Intrapartum Oropharyngeal (IP-OP) Suction in Neonates Born Through Meconium Stained Amniotic Fluid on Meconium Aspiration Syndrome

Brief 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.

Detailed Summary:

Meconium passage in newborn infants is a developmentally programmed event normally occurring within first 24-48 hours of birth. Intra uterine meconium passage in near term or term fetuses has been associated with feto-maternal stress factors and/or infections, whereas meconium passage in post term pregnancies has been attributed to gastro-intestinal maturity. Meconium staining of amniotic fluid occurs in 12% of all live births per annuum. Aspiration of meconium that occurs during intra uterine life or after delivery with the first few breaths may result in or contribute to respiratory pathology known as meconium aspiration syndrome (MAS) which represents a leading cause of perinatal morbidity, occurring in 5-20% of all babies born through MSAF.

Several studies have shown that by clearing the airways of meconium at the time of birth, meconium aspiration pneumonia can be virtually eliminated. Based on these results, the American Heart Association and American Academy of Pediatrics had recommended a combined obstetric and pediatric approach to the infant with MSAF in the year 2000. As per this approach infants mouth, pharynx and nose were to be suctioned as soon as the head of the infant is delivered prior to delivery of the shoulders using a 10 french catheter followed by tracheal intubation and suction in non-vigorous infants to clear the airways of the meconium.

Accumulating evidence in the form of a large RCT from developed world has shown the futility of intrapartum-oropharyngeal suction leading to, omission of this procedure from resuscitation guidelines published in the year 2005.

Even though International Liaison Committee on Resuscitation recommends no need for IP- OP suction based on a single RCT conducted in a developed world with universal institutional deliveries
Sponsor: Lady Hardinge Medical College

Current Primary Outcome: Meconium Aspiration Syndrome [ Time Frame: First 72 hours of life or till discharge ]

Occurrence of Meconium aspiration syndrome as assessed by (all of these)

  • Birth through Meconium Stained Amniotic Fluid,
  • Presence of respiratory distress (as defined as RR>60/min, Subcostal retractions or Intercostal Retractions or Grunt)
  • Need for supplemental oxygen to maintain oxygen saturation > 92%
  • Need for supplemental oxygen by two hours of life and continued beyond 12 hours of life
  • Presence of radiological features of MAS on X-ray chest


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mortality [ Time Frame: First 72 hours of life or till discharge ]
  • Severity of MAS [ Time Frame: First 72 hours of life or till discharge ]

    Severity of MAS was defined as:

    1. Mild MAS: oxygen requirement <40% and for <48 Hours
    2. Moderate MAS: Oxygen requirement of >40% for any duration or oxygen requirement of <40% for>48 hours or need for CPAP
    3. Severe MAS: need for mechanical ventilation
  • Duration of hospital stay [ Time Frame: First 72 hours of life or till discharge ]
  • Respiratory Support [ Time Frame: First 72 hours of life or till discharge ]
    1. Requirement of respiratory support
    2. The mode of respiratory support viz. Supplemental Oxygen therapy, CPAP, Mechanical ventilation, High Frequency ventilation
    3. Duration of each kind of respiratory support required
  • Incidence of air leaks [ Time Frame: First 72 hours of life or till discharge ]
    Pneumothorax as seen by transillumination and confirmed by Chest Xray


Original Secondary Outcome: Same as current

Information By: Lady Hardinge Medical College

Dates:
Date Received: March 31, 2011
Date Started: May 2008
Date Completion:
Last Updated: September 26, 2015
Last Verified: September 2015