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

Primary Purpose

Meconium Aspiration Syndrome

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
No endotracheal suction
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 meconium stained amniotic fluid, endotracheal suction, non vigorous neonates

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

No Endotracheal suction

Endotracheal suction

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Duration of oxygen therapy
duration of oxygen therapy in hours
Duration and severity of respiratory distress by Downe's scoring
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
Total duration of mechanical ventilation, mode and ventilator parameters noted till the baby is on ventilator
HIE(hypoxic ischemic encephalopathy) staging
by Sarnat and Sarnat classification system
Incidence of complications
incidence of PPHN, pneumothorax suspected on clinical basis and confirmed by echocardiography and chest radiography respectively and incidence of sepsis
Duration of hospital stay
duration of hospital stay in completed days

Full Information

First Posted
December 20, 2012
Last Updated
July 9, 2014
Sponsor
Lady Hardinge Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT01758822
Brief Title
Role of Endotracheal Suction on the Occurrence of Meconium Aspiration Syndrome in Non-vigorous Meconium Stained Babies
Acronym
ETMAS
Official Title
Role of Endotracheal Suction on the Occurrence of Meconium Aspiration Syndrome in Non-vigorous Meconium Stained Neonates- A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
September 2013 (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 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).
Detailed Description
Approximately 10-15% of deliveries are complicated by the passage of meconium around the time of delivery.An adverse intrauterine environment with resultant fetal asphyxia is proposed as the most common explanation for in-utero passage of meconium. Aspiration of meconium into the tracheo-bronchial tree with the onset of respiration results in meconium aspiration syndrome (MAS). MAS is defined as respiratory distress in an infant born through MSAF with compatible chest x-ray findings whose symptoms cannot be otherwise explained. Despite current interventions such as intubation and tracheal suction, it is estimated that 5-20 % of infants born through MSAF develop MAS. It represents a leading cause of perinatal morbidity. Approximately 50% of the infants with MAS require mechanical ventilation; 15%-30% develop pulmonary air leaks and 5%-12% die. There are various proposed mechanisms by which meconium causes lung injury, some of the important ones being Mechanical obstruction of airways Chemical pneumonitis Vasoconstriction of pulmonary vessels Inactivation of surfactant Activation of compliment Finding of meconium below cords or in the trachea has been shown to be associated with development of MAS. This resulted in use of endotracheal suction along with oro-nasopharyngeal suctioning in all infants born to mothers with MSAF prior to the year 2000. Although, a number of studies performed did not show reduction in incidence of MAS and/or mortality even after performing oro-nasopharyngeal and endotracheal suction, the practice was continued due to lack of robust evidence. Subsequently, as a result of well performed randomized controlled trials and systematic review showing no effect of oro-nasopharyngeal suctioning on occurrence of MAS, this practice has been abandoned since the year 2005. ET suction is currently performed in depressed meconium stained neonates with the idea of removing meconium from the upper airways to relieve mechanical obstruction and to prevent subsequent development of chemical pneumonitis. Since meconium aspiration can occur in-utero as well and with time the aspirated meconium migrates peripherally, the effectiveness of ET suction post-delivery in clearing the airway is not clear. Furthermore, accumulating evidence points to potential role of hypoxia-asphyxia-acidosis with concomitant presence of meconium in the pathogenesis of lung disease. Current practice of Endotracheal suctioning in non-vigorous babies has not been systematically evaluated, till date. No studies have compared the incidence, severity and outcomes of MAS in 'suctioned versus non-suctioned' non vigorous meconium stained neonates. In addition, the procedure needs expertise to be completed in the stipulated time and has potential for complications like vocal cord injury, laryngeal edema, bleeding from upper airway secondary to trauma during the procedure and persistent hoarseness of voice even at six months of age. The rate of complications is more when performed by people with lesser expertise as this is a difficult skill to learn and master. In view of the foregoing the contribution of endotracheal suction in preventing MAS and its effect on severity of lung disease is not clear. Thus this study is an attempt to evaluate the role of endotracheal suction in non-vigorous meconium stained neonates.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meconium Aspiration Syndrome
Keywords
meconium stained amniotic fluid, endotracheal suction, non vigorous neonates

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
No Endotracheal suction
Arm Type
Experimental
Arm Description
In the experimental group, endotracheal suction will not be performed during the initial steps of resuscitation of non-vigorous meconium stained neonate
Arm Title
Endotracheal suction
Arm Type
No Intervention
Arm Description
In the No intervention group endotracheal suction will be performed during the initial steps of resuscitation of non - vigorous meconium stained neonate
Intervention Type
Other
Intervention Name(s)
No endotracheal suction
Intervention Description
Neonates in this group will be resuscitated without endotracheal suction in the initial steps of resuscitation.
Primary Outcome Measure Information:
Title
Incidence of MAS and death due to all cause
Description
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)
Time Frame
till discharge or death up to 6 weeks of life
Secondary Outcome Measure Information:
Title
Duration of oxygen therapy
Description
duration of oxygen therapy in hours
Time Frame
till discharge or death up to 6 weeks of life
Title
Duration and severity of respiratory distress by Downe's scoring
Description
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.
Time Frame
till discharge or death up to 6 weeks of life
Title
Need for and duration of Mechanical ventilation in hours
Description
Total duration of mechanical ventilation, mode and ventilator parameters noted till the baby is on ventilator
Time Frame
Till discharge or death up to 6 weeks of life
Title
HIE(hypoxic ischemic encephalopathy) staging
Description
by Sarnat and Sarnat classification system
Time Frame
During the first two weeks of life
Title
Incidence of complications
Description
incidence of PPHN, pneumothorax suspected on clinical basis and confirmed by echocardiography and chest radiography respectively and incidence of sepsis
Time Frame
till death or discharge up to 6 weeks of life
Title
Duration of hospital stay
Description
duration of hospital stay in completed days
Time Frame
till death or discharge up to 6 weeks of life

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
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
State/Province
Delhi
ZIP/Postal Code
110001
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
27255954
Citation
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.
Results Reference
derived

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

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