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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sushma Nangia, M.D., Lady Hardinge Medical College
ClinicalTrials.gov Identifier:
NCT01758822
First received: December 20, 2012
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention
Meconium Aspiration Syndrome
Other: No endotracheal suction

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 Endotracheal Suction on the Occurrence of Meconium Aspiration Syndrome in Non-vigorous Meconium Stained Neonates- A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Lady Hardinge Medical College:

Primary Outcome Measures:
  • Incidence of MAS and death due to all cause [ Time Frame: till discharge or death up to 6 weeks of life ] [ Designated as safety issue: No ]

    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)


Secondary Outcome Measures:
  • Duration of oxygen therapy [ Time Frame: till discharge or death up to 6 weeks of life ] [ Designated as safety issue: No ]
    duration of oxygen therapy in hours

  • Duration and severity of respiratory distress by Downe's scoring [ Time Frame: till discharge or death up to 6 weeks of life ] [ Designated as safety issue: No ]
    Severity of respiratory distress is assessed using Downe's score, the parameters are documented hourly within first twelve hours and then every two hourly till persistence of respiratory distress for first seventy hours( whichever is shorter) and on four hourly basis after seventy hours in the presence of respiratory distress.

  • Need for and duration of Mechanical ventilation in hours [ Time Frame: Till discharge or death up to 6 weeks of life ] [ Designated as safety issue: No ]
    Total duration of mechanical ventilation, mode and ventilator parameters noted till the baby is on ventilator

  • HIE(hypoxic ischemic encephalopathy) staging [ Time Frame: During the first two weeks of life ] [ Designated as safety issue: No ]
    by Sarnat and Sarnat classification system

  • Incidence of complications [ Time Frame: till death or discharge up to 6 weeks of life ] [ Designated as safety issue: No ]
    incidence of PPHN, pneumothorax suspected on clinical basis and confirmed by echocardiography and chest radiography respectively and incidence of sepsis

  • Duration of hospital stay [ Time Frame: till death or discharge up to 6 weeks of life ] [ Designated as safety issue: No ]
    duration of hospital stay in completed days


Enrollment: 175
Study Start Date: May 2012
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: No Endotracheal suction
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
Neonates in this group will be resuscitated without endotracheal suction in the initial steps of resuscitation.
No Intervention: Endotracheal suction
In the No intervention group endotracheal suction will be performed during the initial steps of resuscitation of non - vigorous meconium stained neonate

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Major congenital malformations
  • Refusal of consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758822

Locations
India
Kalawati Saran children's Hospital, Lady Hardinge Medical College
New delhi, 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: Sushma Nangia, M.D., Professor of Pediatrics, Lady Hardinge Medical College
ClinicalTrials.gov Identifier: NCT01758822     History of Changes
Other Study ID Numbers: LHMC/2011/PED/019
Study First Received: December 20, 2012
Last Updated: July 9, 2014
Health Authority: India: Indian Council of Medical Research

Keywords provided by Lady Hardinge Medical College:
meconium stained amniotic fluid
endotracheal suction
non vigorous neonates

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

ClinicalTrials.gov processed this record on September 16, 2014