Effect Of Intrapartum Oropharyngeal (IP-OP) Suction on Meconium Aspiration Syndrome

Meconium Aspiration Syndrome Clinical Trial

— MSAF-OPS  

Official title:

Role of Intrapartum Oropharyngeal (IP-OP) Suction in Neonates Born Through Meconium Stained Amniotic Fluid on Meconium Aspiration Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01328483
• Other study ID #: LHMC/21/2008/MSAF-OPS
• Status: Completed
• Phase: N/A
• First received: March 31, 2011
• Last updated: September 26, 2015
• Start date: May 2008
• Est. completion date: April 2009

Study information

• Verified date: September 2015
• Source: Lady Hardinge Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the role of routine suctioning of the oropharynx before the delivery of shoulders in preventing breathing difficulty and subsequent lung disease in babies born through meconium stained amniotic fluid. Normally babies do not pass meconium while in utero. In response to hypoxic stress babies may pass meconium before birth and are likely to be candidates for problems related to meconium passage and its inhalation leading to meconium aspiration syndrome(MAS). It is believed that clearing the airways of meconium at the time of birth can decrease the risk of MAS. It had been a routine practice to suction the mouth, pharynx and nose of the baby as soon as the head of the infant is delivered prior to delivery of the shoulders followed by tracheal intubation and suction in babies with poor breathing efforts to clear the airways of the meconium. however recent studies have shown the futility of this procedure in preventing MAS along with an increased risk of complications to baby due to suctioning. In view of the uncertainty regarding the effectiveness of this procedure in a resource poor country, the investigators decided to evaluate the effect of intrapartum-oropharyngeal suction in preventing or decreasing the incidence of MAS in such babies.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 10 Minutes

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meconium Aspiration Syndrome
• Syndrome

Intervention

Procedure:
• Intrapartum Oropharyngeal Suctioning
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

Locations

Country	Name	City	State
India	Kalawati Saran children's Hospital, Lady Hardinge Medical College	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Lady Hardinge Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meconium Aspiration Syndrome	Occurrence of Meconium aspiration syndrome as assessed by (all of these); Birth through Meconium Stained Amniotic Fluid,; Presence of respiratory distress (as defined as RR>60/min, Subcostal retractions or Intercostal Retractions or Grunt); Need for supplemental oxygen to maintain oxygen saturation > 92%; Need for supplemental oxygen by two hours of life and continued beyond 12 hours of life; Presence of radiological features of MAS on X-ray chest	First 72 hours of life or till discharge	No
Secondary	Mortality		First 72 hours of life or till discharge	No
Secondary	Severity of MAS	Severity of MAS was defined as: Mild MAS: oxygen requirement <40% and for <48 Hours; Moderate MAS: Oxygen requirement of >40% for any duration or oxygen requirement of <40% for>48 hours or need for CPAP; Severe MAS: need for mechanical ventilation	First 72 hours of life or till discharge	No
Secondary	Duration of hospital stay		First 72 hours of life or till discharge	No
Secondary	Respiratory Support	Requirement of respiratory support; The mode of respiratory support viz. Supplemental Oxygen therapy, CPAP, Mechanical ventilation, High Frequency ventilation; Duration of each kind of respiratory support required	First 72 hours of life or till discharge	No
Secondary	Incidence of air leaks	Pneumothorax as seen by transillumination and confirmed by Chest Xray	First 72 hours of life or till discharge	No