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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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 (MA

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 Summary:

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.


Sponsor: Windtree Therapeutics

Current Primary Outcome: 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.


Original Primary Outcome:

Current Secondary Outcome:

  • Incidence of Death [ Time Frame: 28 days ]
  • Number of Participants With Air Leaks [ Time Frame: 28 days ]
    Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium


Original Secondary Outcome:

Information By: Windtree Therapeutics

Dates:
Date Received: October 18, 1999
Date Started: March 2000
Date Completion:
Last Updated: May 1, 2012
Last Verified: May 2012