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

NCT01328483 | Completed DMC

• 1 other identifier: LHMC/21/2008/MSAF-OPS
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

Meconium Aspiration Syndrome

Keywords

Neonates; Intrapartum Oropharyngeal Suctioning; Meconium Aspiration Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

  First 72 hours of life or till discharge

Secondary Outcomes (5)

• Mortality

  First 72 hours of life or till discharge

• Severity of MAS

  First 72 hours of life or till discharge

• Duration of hospital stay

  First 72 hours of life or till discharge

• Respiratory Support

  First 72 hours of life or till discharge

• Incidence of air leaks

  First 72 hours of life or till discharge

Study Arms (2)

No Intrapartum Oropharyngeal (IP-OP) Suction

NO INTERVENTION

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.

Intrapartum Oropharyngeal (IP-OP) suction

EXPERIMENTAL

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

Interventions

Intrapartum Oropharyngeal Suctioning PROCEDURE

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

Intrapartum Oropharyngeal (IP-OP) suction

Eligibility Criteria

• Age: Up to 10 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Babies with major congenital malformations (if known antenatally)
• Hydrops fetalis
• Refusal of consent
• Chromosomal anomalies

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

Study Sites (1)

Kalawati Saran children's Hospital, Lady Hardinge Medical College

New Delhi, New delhi, 110001, India

Location

Related Publications (1)

• 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.

  PMID: 26449871 DERIVED

MeSH Terms

Conditions

Meconium Aspiration Syndrome

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Sushma Nangia, MBBS, MD, DM

  Lady Hardinge Medical College, New Delhi, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Neonatology

Study Record Dates

• First Submitted: March 31, 2011
• First Posted: April 4, 2011
• Study Start: May 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: September 29, 2015

Record last verified: 2015-09

Locations

IN (1)