- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01328483
Effect Of Intrapartum Oropharyngeal (IP-OP) Suction on Meconium Aspiration Syndrome (MSAF-OPS)
Role of Intrapartum Oropharyngeal (IP-OP) Suction in Neonates Born Through Meconium Stained Amniotic Fluid on Meconium Aspiration Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Meconium passage in newborn infants is a developmentally programmed event normally occurring within first 24-48 hours of birth. Intra uterine meconium passage in near term or term fetuses has been associated with feto-maternal stress factors and/or infections, whereas meconium passage in post term pregnancies has been attributed to gastro-intestinal maturity. Meconium staining of amniotic fluid occurs in 12% of all live births per annuum. Aspiration of meconium that occurs during intra uterine life or after delivery with the first few breaths may result in or contribute to respiratory pathology known as meconium aspiration syndrome (MAS) which represents a leading cause of perinatal morbidity, occurring in 5-20% of all babies born through MSAF.
Several studies have shown that by clearing the airways of meconium at the time of birth, meconium aspiration pneumonia can be virtually eliminated. Based on these results, the American Heart Association and American Academy of Pediatrics had recommended a combined obstetric and pediatric approach to the infant with MSAF in the year 2000. As per this approach infants mouth, pharynx and nose were to be suctioned as soon as the head of the infant is delivered prior to delivery of the shoulders using a 10 french catheter followed by tracheal intubation and suction in non-vigorous infants to clear the airways of the meconium.
Accumulating evidence in the form of a large RCT from developed world has shown the futility of intrapartum-oropharyngeal suction leading to, omission of this procedure from resuscitation guidelines published in the year 2005.
Even though International Liaison Committee on Resuscitation recommends no need for IP- OP suction based on a single RCT conducted in a developed world with universal institutional deliveries and strict fetal surveillance, the same may not be true in set ups with unbooked and late second stage arrivals of the mother with prolonged fetal distress and virtually no perinatal surveillance.
Hence the purpose of this randomized controlled trial is to evaluate the effectiveness of intrapartum-oropharyngeal suction in preventing or decreasing the incidence of MAS in term neonates born through MSAF in resource poor setting in a developing country.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Delhi, India, 110001
- Kalawati Saran children's Hospital, Lady Hardinge Medical College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Gestation >/= 37 weeks
- Meconium staining of amniotic fluid
- Cephalic presentation
- Singleton pregnancy
Exclusion Criteria:
- Babies with major congenital malformations (if known antenatally)
- Hydrops fetalis
- Refusal of consent
- Chromosomal anomalies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: No Intrapartum Oropharyngeal (IP-OP) Suction
Neonates randomized to No IP-OP group received supportive treatment as per standard unit protocols.
They were also assessed as vigorous or non-vigorous and received care according to NRP 2005.
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Experimental: Intrapartum Oropharyngeal (IP-OP) suction
The neonates randomized to IP-OP group were provided oropharyngeal suctioning at the delivery of head before the delivery of shoulder, using suction machine at a negative pressure of 100mm of Hg or Dee Lee's suction trap in the event of electricity failure or non availability of suction machine.Subsequently, all the neonates born through MSAF were assessed by pediatrician as vigorous or non vigorous and provided care as per NRP guidelines 2005.
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After delivery of the head, the infant's mouth and nose were suctioned.
Nose was suctioned after the mouth and throat.
Oropharyngeal suctioning was performed using a 10 french suction catheter with suction pressure of 100mm Hg or De Lee's suction trap in event of electricity failure or non availability of suction machine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Meconium Aspiration Syndrome
Time Frame: First 72 hours of life or till discharge
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Occurrence of Meconium aspiration syndrome as assessed by (all of these)
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First 72 hours of life or till discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: First 72 hours of life or till discharge
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First 72 hours of life or till discharge
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Severity of MAS
Time Frame: First 72 hours of life or till discharge
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Severity of MAS was defined as:
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First 72 hours of life or till discharge
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Duration of hospital stay
Time Frame: First 72 hours of life or till discharge
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First 72 hours of life or till discharge
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Respiratory Support
Time Frame: First 72 hours of life or till discharge
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First 72 hours of life or till discharge
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Incidence of air leaks
Time Frame: First 72 hours of life or till discharge
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Pneumothorax as seen by transillumination and confirmed by Chest Xray
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First 72 hours of life or till discharge
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sushma Nangia, MBBS, MD, DM, Lady Hardinge Medical College, New Delhi, India
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LHMC/21/2008/MSAF-OPS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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