Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome

Windtree Therapeutics

Status and phase: Terminated; Phase 3

Conditions: Meconium Aspiration

Treatments: Drug: Lucinactant; Other: Standard Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT00004500

KL4-MAS-03

FD-R-001938 (Other Grant/Funding Number)

Details and patient eligibility

About

OBJECTIVES:

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

Full description

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.

Enrollment: 69 patients

Sex: All

Ages: Under 48 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

Lucinactant

Experimental group

Description:

Lucinactant via bronchoaveolar lavage

Treatment:

Drug: Lucinactant

Standard Care

Other group

Description:

Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization

Treatment:

Other: Standard Care