Comparison Of Surfactant Lung Lavage With Standard Care In The Treatment Of Meconium Aspiration Syndrome
Condition: Meconium Aspiration Syndrome
MeSH terms: Meconium Aspiration Syndrome; Syndrome
Study type: Interventional

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 description: 
      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 or washing out
      surfactant, followed by appropriate ventilator care.

      Surfactant replacement in neonates with severe meconium aspiration syndrome has been shown to
      improve oxygenation and reduce the severity of respiratory failure, air leaks and need for
      extracorporeal membrane oxygenation.

      Surfactant replacement alone does not remove the meconium present in the airways and hence
      multiple doses may be required. Therefore an effective strategy to improve outcome in
      neonates with MAS needs to not only remove meconium but also retain the surfactant for
      adequate lung expansion and function.

      Lung lavage using diluted surfactant has recently been shown to be an alternative to bolus
      therapy in treating MAS. This has advantage of removing surfactant inhibitors from alveolar
      space, in addition to augmenting surfactant concentration in alveolar space. Initial pilot
      case series using surfactant lung lavage have shown promise and there is a need to
      systematically study this in a RCT. The same has also been expressed in the literature on
      this subject. Hence the purpose of this prospective randomized controlled trial is to compare
      the efficacy of surfactant lung lavage over standard therapy in the treatment of meconium
      aspiration syndrome.
    

Intervention name(s): Bovine surfactant
Intervention type(s): Drug
Intervention description(s): Dose of diluted surfactant : 20ml/kg
Type :Bovine surfactant
Phospholipid concentration: 5 mg/ml
Number of lavages to be given: 2 (10ml/kg each)
Intervention MeSH terms: Pulmonary Surfactants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neonate; Meconium aspiration syndrome; surfactant lung lavage