Role of Oropharyngeal Suctioning at Delivery of Shoulders in Preventing Meconium Aspiration Syndrome in Babies Born Through Meconium Stained Amniotic Fluid (MSAF-OPS)

This study has been completed.
Sponsor:
Information provided by:
Lady Hardinge Medical College
ClinicalTrials.gov Identifier:
NCT01328483
First received: March 31, 2011
Last updated: April 1, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Meconium Aspiration Syndrome
Procedure: Intrapartum Oropharyngeal Suctioning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Role of Intrapartum Oropharyngeal Suctioning in Neonates Born Through Meconium Stained Amniotic Fluid In Preventing Meconium Aspiration Syndrome

Resource links provided by NLM:


Further study details as provided by Lady Hardinge Medical College:

Primary Outcome Measures:
  • Meconium Aspiration Syndrome [ Time Frame: First 72 hours of life or till discharge ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Mortality [ Time Frame: First 72 hours of life or till discharge ] [ Designated as safety issue: No ]
  • Severity of MAS [ Time Frame: First 72 hours of life or till discharge ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Respiratory Support [ Time Frame: First 72 hours of life or till discharge ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Pneumothorax as seen by transillumination and confirmed by Chest Xray


Enrollment: 540
Study Start Date: May 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Intrapartum Oropharyngeal Suctioning (No IP-OP)
Neonates randomized to No IP-OP group received supportive treatment as per standard unit protocols. They were also assessed as vigorous or non-vigorous and received care according to NRP 2005.
Experimental: Intrapartum Oropharyngeal suctioning (IP-OP)
The neonates randomized to IP-OP group were provided oropharyngeal suctioning at the delivery of head before the delivery of shoulder, using suction machine at a negative pressure of 100mm of Hg or Dee Lee's suction trap in the event of electricity failure or non availability of suction machine.Subsequently, all the neonates born through MSAF were assessed by pediatrician as vigorous or non vigorous and provided care as per NRP guidelines 2005.
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

Detailed Description:

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 and strict fetal surveillance, the same may not be true in set ups with unbooked and late second stage arrivals of the mother with prolonged fetal distress and virtually no perinatal surveillance.

Hence the purpose of this randomized controlled trial is to evaluate the effectiveness of intrapartum-oropharyngeal suction in preventing or decreasing the incidence of MAS in term neonates born through MSAF in resource poor setting in a developing country.

  Eligibility

Ages Eligible for Study:   up to 10 Minutes
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestation >/= 37 weeks
  • Meconium staining of amniotic fluid
  • Cephalic presentation
  • Singleton pregnancy

Exclusion Criteria:

  • Babies with major congenital malformations (if known antenatally)
  • Hydrops fetalis
  • Refusal of consent
  • Chromosomal anomalies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328483

Locations
India
Kalawati Saran children's Hospital, Lady Hardinge Medical College
New Delhi, India, 110001
Sponsors and Collaborators
Lady Hardinge Medical College
Investigators
Principal Investigator: Sushma Nangia, MBBS, MD, DM Lady Hardinge Medical College, New Delhi, India
  More Information

No publications provided

Responsible Party: Dr Sushma Nangia, Professor of Pediatrics, Lady Hardinge Medical College, New Delhi, India
ClinicalTrials.gov Identifier: NCT01328483     History of Changes
Other Study ID Numbers: LHMC/21/2008/MSAF-OPS
Study First Received: March 31, 2011
Last Updated: April 1, 2011
Health Authority: India: Indian Council of Medical Research

Keywords provided by Lady Hardinge Medical College:
Neonates
Intrapartum Oropharyngeal Suctioning
Meconium Aspiration Syndrome

Additional relevant MeSH terms:
Meconium Aspiration Syndrome
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Fetal Diseases
Pregnancy Complications
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on April 17, 2014