Role of Endotracheal Suction on the Occurrence of Meconium Aspiration Syndrome in Non-vigorous Meconium Stained Babies

NCT01758822 | Completed DMC

• 1 other identifier: LHMC/2011/PED/019
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the role of endotracheal suction on the occurrence of meconium aspiration syndrome in depressed meconium stained babies. Meconium aspiration syndrome (MAS) is believed to result from aspiration of meconium and consequent chemical pneumonitis. Meconium can be aspirated into the lungs in the womb as well. Meconium in the distal airways is not accessible to endotracheal (ET) suction which clears only the windpipe. Furthermore there is growing evidence in support of asphyxia-hypoxia-acidosis in the causation of lung disease. Moreover, in the absence of a clear role of ET suction in depressed meconium stained newborns, critical time could be lost in assessment, intubation and ET suction (range: 30 seconds to 1 min) which might delay the definitive step of ventilation for resuscitation of such babies that can potentially affect the outcome adversely.The utility or futility of endotracheal suction in preventing MAS in depressed meconium stained neonates has not been systematically studied and there is inadequate information in literature in favor or against this practice.Thus this study is an attempt to evaluate the effect of endotracheal suction on the occurrence of MAS in depressed full term neonates born through meconium stained amniotic fluid (MSAF).

Conditions

Meconium Aspiration Syndrome

Keywords

meconium stained amniotic fluid; endotracheal suction; non vigorous neonates

Outcome Measures

Primary Outcomes (1)

• Incidence of MAS and death due to all cause

  MAS is defined as meconium staining of liquor or staining of nails or umbilical cord or skin along with presence of any one of the following: * Respiratory distress within one hour of birth OR * Radiological evidence of aspiration pneumonitis (atelectasis and/or hyperinflation)

  till discharge or death up to 6 weeks of life

Secondary Outcomes (6)

• Duration of oxygen therapy

  till discharge or death up to 6 weeks of life

• Duration and severity of respiratory distress by Downe's scoring

  till discharge or death up to 6 weeks of life

• Need for and duration of Mechanical ventilation in hours

  Till discharge or death up to 6 weeks of life

• HIE(hypoxic ischemic encephalopathy) staging

  During the first two weeks of life

• Incidence of complications

  till death or discharge up to 6 weeks of life

Study Arms (2)

No Endotracheal suction

EXPERIMENTAL

In the experimental group, endotracheal suction will not be performed during the initial steps of resuscitation of non-vigorous meconium stained neonate

Other: No endotracheal suction

Endotracheal suction

NO INTERVENTION

In the No intervention group endotracheal suction will be performed during the initial steps of resuscitation of non - vigorous meconium stained neonate

Interventions

No endotracheal suction OTHER

Neonates in this group will be resuscitated without endotracheal suction in the initial steps of resuscitation.

No Endotracheal suction

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestation age \> 37 weeks
• Cephalic Presentation
• Singleton pregnancy
• Presence of meconium stained amniotic fluid
• Nonvigorous at birth

You may not qualify if:

• Major congenital malformations
• Refusal of consent

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

Study Sites (1)

Kalawati Saran children's Hospital, Lady Hardinge Medical College

New Delhi, National Capital Territory of Delhi, 110001, India

Location

Related Publications (1)

• Nangia S, Sunder S, Biswas R, Saili A. Endotracheal suction in term non vigorous meconium stained neonates-A pilot study. Resuscitation. 2016 Aug;105:79-84. doi: 10.1016/j.resuscitation.2016.05.015. Epub 2016 May 30.

  PMID: 27255954 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 of Pediatrics

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: January 1, 2013
• Study Start: May 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: July 10, 2014

Record last verified: 2014-07

Locations

IN (1)