Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
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|ClinicalTrials.gov Identifier: NCT00004500|
Recruitment Status : Terminated (Slow enrollment and administrative reasons)
First Posted : October 19, 1999
Results First Posted : May 1, 2012
Last Update Posted : May 3, 2012
Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.
|Condition or disease||Intervention/treatment||Phase|
|Meconium Aspiration||Drug: Lucinactant Other: Standard Care||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2000|
|Actual Primary Completion Date :||November 2002|
|Actual Study Completion Date :||November 2004|
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
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004500
|United States, Pennsylvania|
|Discovery Laboratories, Inc.|
|Warrington, Pennsylvania, United States, 18976|
|Study Chair:||Thomas E Wiswell||Windtree Therapeutics|