NCT00004500|TerminatedPhase 3ResultsDMC
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Slow enrollment and administrative reasons
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
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · US Department of Health and Human Services
interventional
69
1 country
1
Study Start
March 2000
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2002
Actual (reported)Study Completion
November 2004
Actual (reported)OBJECTIVES: Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2004
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 18, 1999
Actual (reported)October 19, 1999
Actual (reported)March 2000
Date type not reportedThis date has not been verified as actual or estimated.
November 2002
Actual (reported)November 2004
Actual (reported)May 1, 2012
Actual (reported)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.
28 days
Incidence of Death
28 days
Number of Participants With Air Leaks
28 days
Lucinactant via bronchoaveolar lavage
Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
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.
Discovery Laboratories, Inc.
Warrington, Pennsylvania, 18976, United States
Early termination led to a small number of subjects analyzed. Results should be interpreted with caution.
Thomas E Wiswell
Windtree Therapeutics
69 participants (actual enrollment reported by the registry).
First Submitted
October 18, 1999
First Posted
October 19, 1999
Study Start
March 2000
Date type not reportedThis date has not been verified as actual or estimated.
Lung Lavage With Dilute Poractant Alfa for Meconium Aspiration Syndrome
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
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Primary Completion
November 2002
Actual (reported)Study Completion
November 2004
Actual (reported)Last Updated
May 3, 2012
Results First Posted
May 1, 2012
Record last verified: 2012-05
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Source: ClinicalTrials.gov.
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