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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Role of Endotracheal Suction on the Occurrence of Meconium Aspiration Syndrome in Non-vigorous Meconium Stained Neonates- A Randomized Controlled Trial

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 Summary:

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 aft
Sponsor: Lady Hardinge Medical College

Current Primary Outcome: Incidence of MAS and death due to all cause [ Time Frame: till discharge or death up to 6 weeks of life ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Duration of oxygen therapy [ Time Frame: till discharge or death up to 6 weeks of life ]
  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 ]
  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 ]
  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 ]
  by Sarnat and Sarnat classification system
• Incidence of complications [ Time Frame: till death or discharge up to 6 weeks of life ]
  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 ]
  duration of hospital stay in completed days

Original Secondary Outcome: Same as current

Information By: Lady Hardinge Medical College

Dates:
Date Received: December 20, 2012
Date Started: May 2012
Date Completion:
Last Updated: July 9, 2014
Last Verified: July 2014