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

Phase 3TerminatedNCT00004500

Windtree Therapeutics69 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Meconium Aspiration

Interventions

LucinactantDRUG

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 CareOTHER

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

Eligibility

Sex: ALLMax age: 48 Hours

Medical Language ↔ Plain English

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

Locations (1)

Discovery Laboratories, Inc.

Warrington, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 28 days

Secondary Outcomes

Incidence of Death

Time frame: 28 days

Number of Participants With Air Leaks

Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium

Time frame: 28 days

Data from ClinicalTrials.gov

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