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

Phase 3

Terminated

• Conditions: Meconium Aspiration
• Interventions: Drug: Lucinactant; Other: Standard Care

• Registration Number: NCT00004500
• Lead Sponsor: Windtree Therapeutics

Brief Summary

OBJECTIVES:

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

Detailed 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.

Study Timeline

• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Study Start: 2000-03
• Primary Completion: 2002-11
• Study Completion: 2004-11
• Results First Submitted: 2012-04-02
• Results First Submitted QC: 2012-04-02
• Status Verified: 2012-05
• Results First Posted: 2012-05-01
• Last Update Submitted: 2012-05-01
• Last Update Posted: 2012-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lucinactant	Lucinactant	Lucinactant via bronchoaveolar lavage
Standard Care	Standard Care	Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization

Primary Outcome Measures

Name	Time	Method
Number of Days Receiving Mechanical Ventilation (MV)	28 days	A patient is not receiving MV if he/she is removed from the mechanical ventilator for ≥ 24 hours. If a patient subsequently requires intubation and MV, the additional time will count as days receiving MV.

Secondary Outcome Measures

Name	Time	Method
Incidence of Death	28 days
Number of Participants With Air Leaks	28 days	Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium

Trial Locations

Locations (1)

Discovery Laboratories, Inc.; 🇺🇸 Warrington, Pennsylvania, United States