Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 (MAS) in Newborn Infants|
- Number of Days Receiving Mechanical Ventilation (MV) [ Time Frame: 28 days ] [ Designated as safety issue: No ]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.
- Incidence of Death [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Number of Participants With Air Leaks [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium
|Study Start Date:||March 2000|
|Study Completion Date:||November 2004|
|Primary Completion Date:||November 2002 (Final data collection date for primary outcome measure)|
Lucinactant via bronchoaveolar lavage
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 Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
Other: Standard Care
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
Other Name: Negative Control
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004500
|United States, Pennsylvania|
|Discovery Laboratories, Inc.|
|Warrington, Pennsylvania, United States, 18976|
|Study Chair:||Thomas E Wiswell||Windtree Therapeutics|