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

NCT ID: NCT00004500

Last Updated: 2012-05-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-03-31
• Study Completion Date: 2004-11-30

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.

Conditions

Meconium Aspiration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lucinactant

Lucinactant via bronchoaveolar lavage

Group Type: EXPERIMENTAL

Lucinactant

Intervention Type: DRUG

Lucinactant suspension was administered as 10 mg total phospholipid (TPL)/mL, by bronchoalveolar lavage within 90 minutes of randomization. The dose was determined based on the infant's body weight such that the total dose was 16 mL/kg for each of the 2 lavage procedures and 32 mL/kg overall. Infants received 2 doses of lucinactant. Each dose consisted of separate lavage procedures for each lung within 15 minutes (up to 60 minutes) of each other.

Standard Care

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

Group Type: OTHER

Standard Care

Intervention Type: OTHER

The Standard Care (SC) group received therapies including, but not limited to, the use of oxygen, controlled mechanical ventilation (CMV), sedation, paralysis, vasopressors, and/or alkalinization. The use of adjunctive therapies (namely: high frequency oscillatory ventilation, high frequency jet ventilation, bolus surfactant, inhaled nitric oxide, extra-corporeal membrane oxygenation, or systemic corticosteroids) were not included in SC

Interventions

Lucinactant

Lucinactant suspension was administered as 10 mg total phospholipid (TPL)/mL, by bronchoalveolar lavage within 90 minutes of randomization. The dose was determined based on the infant's body weight such that the total dose was 16 mL/kg for each of the 2 lavage procedures and 32 mL/kg overall. Infants received 2 doses of lucinactant. Each dose consisted of separate lavage procedures for each lung within 15 minutes (up to 60 minutes) of each other.

Intervention Type: DRUG

Standard Care

The Standard Care (SC) group received therapies including, but not limited to, the use of oxygen, controlled mechanical ventilation (CMV), sedation, paralysis, vasopressors, and/or alkalinization. The use of adjunctive therapies (namely: high frequency oscillatory ventilation, high frequency jet ventilation, bolus surfactant, inhaled nitric oxide, extra-corporeal membrane oxygenation, or systemic corticosteroids) were not included in SC

Intervention Type: OTHER

Other Intervention Names

Surfactant; KL₄Surfactant; Negative Control

Eligibility 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

• Maximum Eligible Age: 48 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Windtree Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas E Wiswell

Role: STUDY_CHAIR

Windtree Therapeutics

Locations

Discovery Laboratories, Inc.

Warrington, Pennsylvania, United States

Countries

United States

Other Identifiers

FD-R-001938

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KL4-MAS-03

Identifier Type: -

Identifier Source: org_study_id