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

Primary Purpose

Meconium Aspiration Syndrome

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Intrapartum Oropharyngeal Suctioning
Sponsored by
Lady Hardinge Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meconium Aspiration Syndrome focused on measuring Neonates, Intrapartum Oropharyngeal Suctioning, Meconium Aspiration Syndrome

Eligibility Criteria

undefined - 10 Minutes (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kalawati Saran children's Hospital, Lady Hardinge Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Intrapartum Oropharyngeal (IP-OP) Suction

Intrapartum Oropharyngeal (IP-OP) suction

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Meconium Aspiration Syndrome
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
Severity of MAS
Severity of MAS was defined as: Mild MAS: oxygen requirement <40% and for <48 Hours Moderate MAS: Oxygen requirement of >40% for any duration or oxygen requirement of <40% for>48 hours or need for CPAP Severe MAS: need for mechanical ventilation
Duration of hospital stay
Respiratory Support
Requirement of respiratory support The mode of respiratory support viz. Supplemental Oxygen therapy, CPAP, Mechanical ventilation, High Frequency ventilation Duration of each kind of respiratory support required
Incidence of air leaks
Pneumothorax as seen by transillumination and confirmed by Chest Xray

Full Information

First Posted
March 31, 2011
Last Updated
September 26, 2015
Sponsor
Lady Hardinge Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT01328483
Brief Title
Effect Of Intrapartum Oropharyngeal (IP-OP) Suction on Meconium Aspiration Syndrome
Acronym
MSAF-OPS
Official Title
Role of Intrapartum Oropharyngeal (IP-OP) Suction in Neonates Born Through Meconium Stained Amniotic Fluid on Meconium Aspiration Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lady Hardinge Medical College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meconium Aspiration Syndrome
Keywords
Neonates, Intrapartum Oropharyngeal Suctioning, Meconium Aspiration Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
540 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Intrapartum Oropharyngeal (IP-OP) Suction
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intrapartum Oropharyngeal (IP-OP) suction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intrapartum Oropharyngeal Suctioning
Intervention Description
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
Primary Outcome Measure Information:
Title
Meconium Aspiration Syndrome
Description
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
Time Frame
First 72 hours of life or till discharge
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
First 72 hours of life or till discharge
Title
Severity of MAS
Description
Severity of MAS was defined as: Mild MAS: oxygen requirement <40% and for <48 Hours Moderate MAS: Oxygen requirement of >40% for any duration or oxygen requirement of <40% for>48 hours or need for CPAP Severe MAS: need for mechanical ventilation
Time Frame
First 72 hours of life or till discharge
Title
Duration of hospital stay
Time Frame
First 72 hours of life or till discharge
Title
Respiratory Support
Description
Requirement of respiratory support The mode of respiratory support viz. Supplemental Oxygen therapy, CPAP, Mechanical ventilation, High Frequency ventilation Duration of each kind of respiratory support required
Time Frame
First 72 hours of life or till discharge
Title
Incidence of air leaks
Description
Pneumothorax as seen by transillumination and confirmed by Chest Xray
Time Frame
First 72 hours of life or till discharge

10. Eligibility

Sex
All
Maximum Age & Unit of Time
10 Minutes
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sushma Nangia, MBBS, MD, DM
Organizational Affiliation
Lady Hardinge Medical College, New Delhi, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kalawati Saran children's Hospital, Lady Hardinge Medical College
City
New Delhi
ZIP/Postal Code
110001
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
26449871
Citation
Nangia S, Pal MM, Saili A, Gupta U. Effect of intrapartum oropharyngeal (IP-OP) suction on meconium aspiration syndrome (MAS) in developing country: A RCT. Resuscitation. 2015 Dec;97:83-7. doi: 10.1016/j.resuscitation.2015.09.394. Epub 2015 Oct 11.
Results Reference
derived

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

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