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 ]
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