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

NCT01310621 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-07-15

No results posted yet for this study

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.

Conditions

  • Meconium Aspiration Syndrome

Interventions

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)

Sponsors & Collaborators

  • Lady Hardinge Medical College

    lead OTHER_GOV

Principal Investigators

  • Sushma Nangia, MBBS, MD, DM · Lady Hardinge Medical College, New Delhi, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Minutes
Max Age
2 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-01-31
Completion
2012-04-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01310621 on ClinicalTrials.gov