Clinical Trial: Comparison Of Surfactant Lung Lavage With Standard Care In The Treatment Of Meconium Aspiration Syndrome

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

Official Title: Surfactant Lung Lavage Versus Standard Care In The Treatment Of Meconium Aspiration Syndrome- A Randomized Controlled Study

Brief Summary: The purpose of this study is to evaluate the role of surfactant lung lavage in the treatment of meconium aspiration syndrome. Aspiration of meconium into the tracheo-bronchial tree with the onset of respiration results in meconium aspiration syndrome (MAS). Aspirated meconium inhibits surfactant function directly and also decreases its synthesis by its toxic effects on type 2 pneumocytes. There is no specific treatment recommended for meconium aspiration syndrome. Numerous studies have shown that exogenous surfactant improves outcome in babies with meconium aspiration. Surfactant replacement alone does not remove meconium from airways and multiple doses may be required .Therefore an effective therapy to improve outcome is crucial in treating infants with meconium aspiration. Surfactant Lung lavage has been shown to be alternative to bolus therapy in treating neonates with meconium aspiration as shown by many pilot studies. So the investigators have decided to study the role surfactant lung lavage in the treatment of meconium aspiration syndrome.

Detailed Summary:

Meconium is an odourless, thick, blackish green material first demonstrable in the foetal intestinal tract during the third month of gestation. Approximately 10-15% of deliveries are complicated by the passage of meconium around the time of delivery. The risk of meconium stained amniotic fluid (MSAF) is strongly correlated with gestational age. An adverse intrauterine environment with resultant foetal asphyxia is proposed as the most common explanation for MSAF.

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 with compatible chest x-ray finding in an infant born through MSAF whose symptoms cannot be otherwise explained. Despite current interventions such as intubation with 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.

The pathophysiology of meconium aspiration syndrome includes airway obstruction, surfactant inactivation, inflammation and pulmonary hypertension. Meconium itself inactivates the surfactant in the alveoli and its presence also causes secondary surfactant deficiency as meconium is toxic to type 2 alveolar cells which secrete surfactant. There is no specific treatment recommended for meconium aspiration syndrome .Treatment for MAS is generally supportive and includes supplemental oxygen as needed, assisted ventilation to maintain lung volume and improve gas exchange, and circulatory support with volume resuscitation and vasopressor infusions to maintain adequate perfusion. Successful treatment of meconium aspiration relies on effective meconium removal without inactivating
Sponsor: Lady Hardinge Medical College

Current Primary Outcome:

  • duration of oxygen therapy in hours [ Time Frame: till discharge or death ]
    The duration of oxygen therapy, mode of delivery, FiO2 and flow rate will be documented hourly within first 2 hours before lavage and in post lavage- hourly up to first 24 hours, 2 hourly up to 72 hours and 4 hourly thereafter till the cessation of oxygen therapy
  • Severity of respiratory distress [ Time Frame: till discharge or death ]
    The severity of respiratory distress will be assessed using Downe's Score. These parameters will be documented hourly within first 2 hours before lavage and in post lavage hourly up to first 24 hours, 2 hourly up to 72 hours and 4 hourly thereafter till the cessation of respiratory distress
  • need for mechanical ventilation [ Time Frame: till discharge or death ]
    The babies will be assessed for the need for mechanical ventilation as per standard unit protocols.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of mechanical ventilation [ Time Frame: till discharge or death ]
    Total duration of mechanical ventilation, mode and ventilator parameters are noted till the baby is on mechanical ventilation.
  • Complications [ Time Frame: till discharge ]
    Incidence of PPHN by Echocardiography and Pneumothorax by transillumination confirmed by chest x-ray.
  • Incidence of sepsis [ Time Frame: till discharge ]

    Incidence of sepsis defined as -

    1. SUSPECTED SEPSIS - Sepsis Screen > 2 parameters positive and/or
    2. CONFIRMED SEPSIS - Sepsis Screen positive + Blood or CSF culture positive for bacteria.

    Sepsis Screen

    1. Total leukocyte count < 5000/mm3
    2. Absolute neutrophil count < 1800/cu.mm.(Low counts as per Manroe chart for term neonates)
    3. Immature/total neutrophil ratio > 0.2
    4. Micro-ESR > 15mm in 1st hour
    5. C Reactive Protein (CRP) > 1 mg/dl
  • Mortality [ Time Frame: till discharge ]
  • Duration of Hospital stay [ Time Frame: till discharge ]


Original Secondary Outcome: Same as current

Information By: Lady Hardinge Medical College

Dates:
Date Received: March 7, 2011
Date Started: January 2011
Date Completion:
Last Updated: July 14, 2014
Last Verified: July 2014