Expired Study
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Warrington, Pennsylvania 18976


Purpose:

OBJECTIVES: Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.


Study summary:

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive lucinactant by bronchoalveolar lavage, into the right and left lung, followed by lung drainage. Treatment repeats when patient stabilizes or every 15 minutes for 2 courses. Arm II: Patients receive standard treatment including oxygen, conventional mechanical ventilation, sedation, paralysis, vasopressors, and alkalinization. Patients are followed for 12 months.


Criteria:

Inclusion Criteria: - Diagnosis of meconium aspiration syndrome (MAS) - Continuous mechanical ventilation (CMV) at time of entry - Enrollment within 48 hours of birth - Gestational age of ≥ 37 weeks - Oxygenation index of ≥ 5 and ≤ 30 - Written informed consent signed and dated by the infant's parent(s) or legal guardian(s) Exclusion Criteria: - Congenital anomalies likely to affect any primary or secondary endpoints - Uncontrollable air leaks - Hydrops fetalis - Rupture ≥ 3 weeks of the fetal membranes - Evidence of overwhelming bacterial infection at time of randomization - Markedly labile persistent pulmonary hypertension at time of randomization - Profound neurologic manifestations - Sustained postductal SpO₂of < 87% for ≥ 15 minutes at an FiO₂of 1.00


NCT ID:

NCT00004500


Primary Contact:

Study Chair
Thomas E Wiswell
Discovery Laboratories


Backup Contact:

N/A


Location Contact:

Warrington, Pennsylvania 18976
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2017

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