Meconium Aspiration SyndromeETMASNCT01758822
Role of Endotracheal Suction on the Occurrence of Meconium Aspiration Syndrome in Non-vigorous Meconium Stained Babies
A study testing No endotracheal suction in people with Meconium Aspiration Syndrome, run by Lady Hardinge Medical College at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Meconium Aspiration Syndrome
- What is being tested?
- No endotracheal suction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteIndia
- Study dates
- May 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestation age > 37 weeks
- Cephalic Presentation
- Singleton pregnancy
- Presence of meconium stained amniotic fluid
- Nonvigorous at birth
Who cannot join
- Major congenital malformations
- Refusal of consent
Trial locations and contacts
1 site in 1 country.
India1 site
Kalawati Saran children's Hospital, Lady Hardinge Medical College
New Delhi, National Capital Territory of Delhi, 110001
About this study
Official title: Role of Endotracheal Suction on the Occurrence of Meconium Aspiration Syndrome in Non-vigorous Meconium Stained Neonates- A Randomized Controlled Trial
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).
Read the 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.
- Conditions
- Meconium Aspiration Syndrome
- Being tested
- No endotracheal suction
- Keywords
- meconium stained amniotic fluid, endotracheal suction, non vigorous neonates
- Medical subject headings
- Meconium Aspiration Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No endotracheal suctionOther
Neonates in this group will be resuscitated without endotracheal suction in the initial steps of resuscitation.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: till discharge or death up to 6 weeks of life
Secondary outcomes (6)
Duration of oxygen therapy
duration of oxygen therapy in hours
Measured: till discharge or death up to 6 weeks of life
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.
Measured: till discharge or death up to 6 weeks of life
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
Measured: Till discharge or death up to 6 weeks of life
HIE(hypoxic ischemic encephalopathy) staging
by Sarnat and Sarnat classification system
Measured: During the first two weeks of life
Incidence of complications
incidence of PPHN, pneumothorax suspected on clinical basis and confirmed by echocardiography and chest radiography respectively and incidence of sepsis
Measured: till death or discharge up to 6 weeks of life
Duration of hospital stay
duration of hospital stay in completed days
Measured: till death or discharge up to 6 weeks of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startMay 2012
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meconium Aspiration SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Hardinge Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sushma Nangia, M.D., Lady Hardinge Medical College
- Investigators
- Sushma Nangia, MBBS, MD, DM, Principal investigator, Lady Hardinge Medical College New Delhi, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758822
- Sponsor's protocol ID
- LHMC/2011/PED/019
- Acronym
- ETMAS
- Status last verified
- Jul 2014
- First submitted
- 20 Dec 2012
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27255954
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Endotracheal Suction on the Occurrence of Meconium Aspiration Syndrome in Non-vigorous Meconium Stained Neonates- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01758822
- Acronym / sponsor ID
- ETMAS / LHMC/2011/PED/019
- Conditions
- Meconium Aspiration Syndrome
- Keywords
- meconium stained amniotic fluid, endotracheal suction, non vigorous neonates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Lady Hardinge Medical CollegeOther government
- Study start
- May 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 1 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Endotracheal suction | Experimental | Other: No endotracheal suctionIn the experimental group, endotracheal suction will not be performed during the initial steps of resuscitation of non-vigorous meconium stained neonate |
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Gestation age > 37 weeks
- Cephalic Presentation
- Singleton pregnancy
- Presence of meconium stained amniotic fluid
- Nonvigorous at birth
Key exclusion criteria (2 listed)
- Major congenital malformations
- Refusal of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No endotracheal suctionNeonates in this group will be resuscitated without endotracheal suction in the initial steps of resuscitation. | Other | No Endotracheal suction |
Primary outcome
Incidence of MAS and death due to all cause
Time frame: till discharge or death up to 6 weeks of life
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)
6 secondary outcomes
Duration of oxygen therapy
Time frame: till discharge or death up to 6 weeks of life
Duration and severity of respiratory distress by Downe's scoring
Time frame: till discharge or death up to 6 weeks of life
Need for and duration of Mechanical ventilation in hours
Time frame: Till discharge or death up to 6 weeks of life
HIE(hypoxic ischemic encephalopathy) staging
Time frame: During the first two weeks of life
Incidence of complications
Time frame: till death or discharge up to 6 weeks of life
Duration of hospital stay
Time frame: till death or discharge up to 6 weeks of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
- Derived from this study: PubMed 27255954Nangia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sushma Nangia, MBBS, MD, DM principal investigator
Lady Hardinge Medical College New Delhi, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No endotracheal suction in people with Meconium Aspiration Syndrome, run by Lady Hardinge Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of MAS and death due to all cause (time frame: till discharge or death up to 6 weeks of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01758822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2014.