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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Meconium Aspiration

Intervention / Treatment
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* Drug: Lucinactant
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lucinactant<br>Lucinactant via bronchoaveolar lavage | Drug: Lucinactant<br>* 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.<br>* Other names: KL₄Surfactant;|
| Other: Standard Care<br>Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization | Other: Standard Care<br>* 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<br>* Other names: Negative Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days Receiving Mechanical Ventilation (MV) | 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. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Death |  | 28 days | 
| Number of Participants With Air Leaks | Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular and respiratory diseases, meconium aspiration syndrome, rare disease