Role of Endotracheal Suction on the Occurrence of Meconium Aspiration Syndrome in Non-vigorous Meconium Stained Babies (ETMAS)
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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 |
- 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)
- 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
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | April 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 |
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| Contact: Sushma Nangia, MBBS, MD, DM | 09810838181 | drsnangia@gmail.com |
| Contact: Arvind Saili, MBBS, MD | 09868117699 | sailiarvind@gmail.com |
| India | |
| Kalawati Saran children's Hospital, Lady Hardinge Medical College | Recruiting |
| New delhi, Delhi, India, 110001 | |
| Contact: Sushma Nangia, MBBS, MD, DM 09810838181 drsnangia@gmail.com | |
| Principal Investigator: Sushma Nangia, MBBS, MD, DM | |
| Sub-Investigator: Shyam S Sundar, MBBS | |
| 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: | December 27, 2012 |
| 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:
|
Meconium Aspiration Syndrome Lung Injury Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Fetal Diseases Pregnancy Complications Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on May 19, 2013