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

Meconium Aspiration Syndrome Clinical Trial

— Sur-Lu-Lav  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310621
• Other study ID #: LHMC/2011/Sur-Lu-Lav
• Status: Completed
• Phase: N/A
• First received: March 7, 2011
• Last updated: July 14, 2014
• Start date: January 2011
• Est. completion date: April 2012

Study information

• Verified date: July 2014
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Hours

Eligibility

Inclusion Criteria:

• Gestation age = 37 week

• Cephalic presentation

• Singleton pregnancy

• Presence of meconium stained amniotic fluid or staining of meconium in skin,umbilical cord or nails.

• Non vigorous babies

• Presence of respiratory distress(Downes score =4)

• Presence of meconium below vocal cords or chest x ray suggestive of meconium aspiration

• Age < 2 hours

Exclusion Criteria:

• Major congenital malformations

• Congenital heart disease

• Hydrops fetalis

• Air leaks

• Pulmonary hemorrhage

Study Design

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

Related Conditions & MeSH terms

• Meconium Aspiration Syndrome
• Syndrome

Intervention

Drug:
• Bovine surfactant
Dose of diluted surfactant : 20ml/kg Type :Bovine surfactant Phospholipid concentration: 5 mg/ml Number of lavages to be given: 2 (10ml/kg each)

Locations

Country	Name	City	State
India	Kalawati Saran children's Hospital, Lady Hardinge Medical College	New Delhi	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	duration of oxygen therapy in hours	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	till discharge or death	No
Primary	Severity of respiratory distress	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	till discharge or death	No
Primary	need for mechanical ventilation	The babies will be assessed for the need for mechanical ventilation as per standard unit protocols.	till discharge or death	No
Secondary	Duration of mechanical ventilation	Total duration of mechanical ventilation, mode and ventilator parameters are noted till the baby is on mechanical ventilation.	till discharge or death	No
Secondary	Complications	Incidence of PPHN by Echocardiography and Pneumothorax by transillumination confirmed by chest x-ray.	till discharge	No
Secondary	Incidence of sepsis	Incidence of sepsis defined as -; SUSPECTED SEPSIS - Sepsis Screen > 2 parameters positive and/or; CONFIRMED SEPSIS - Sepsis Screen positive + Blood or CSF culture positive for bacteria.; Sepsis Screen; Total leukocyte count < 5000/mm3; Absolute neutrophil count < 1800/cu.mm.(Low counts as per Manroe chart for term neonates); Immature/total neutrophil ratio > 0.2; Micro-ESR > 15mm in 1st hour; C Reactive Protein (CRP) > 1 mg/dl	till discharge	No
Secondary	Mortality		till discharge	No
Secondary	Duration of Hospital stay		till discharge	No