A Multicenter, Randomized, Controlled Trial Comparing the Safety and Effectiveness of Bronchoalveolar Lavage With Lucinactant to Standard Care for the Treatment of the Meconium Aspriation Syndrome (MAS) in Newborn Infants
Overview
- Phase
- Phase 3
- Intervention
- Lucinactant
- Conditions
- Meconium Aspiration
- Sponsor
- Windtree Therapeutics
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Number of Days Receiving Mechanical Ventilation (MV)
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
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.
Investigators
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
Arms & Interventions
Lucinactant
Lucinactant via bronchoaveolar lavage
Intervention: Lucinactant
Standard Care
Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
Intervention: Standard Care
Outcomes
Primary Outcomes
Number of Days Receiving Mechanical Ventilation (MV)
Time Frame: 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 Outcomes
- Incidence of Death(28 days)
- Number of Participants With Air Leaks(28 days)