Back to resultsPhase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
Primary Purpose
Meconium Aspiration
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lucinactant
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Meconium Aspiration focused on measuring cardiovascular and respiratory diseases, meconium aspiration syndrome, rare disease
Eligibility Criteria
Inclusion Criteria: Diagnosis of meconium aspiration syndrome (MAS) Continuous mechanical ventilation (CMV) at time of entry Enrollment within 48 hours of birth Gestational age of ≥ 37 weeks Oxygenation index of ≥ 5 and ≤ 30 Written informed consent signed and dated by the infant's parent(s) or legal guardian(s) Exclusion Criteria: Congenital anomalies likely to affect any primary or secondary endpoints Uncontrollable air leaks Hydrops fetalis Rupture ≥ 3 weeks of the fetal membranes Evidence of overwhelming bacterial infection at time of randomization Markedly labile persistent pulmonary hypertension at time of randomization Profound neurologic manifestations Sustained postductal SpO₂of < 87% for ≥ 15 minutes at an FiO₂of 1.00
Sites / Locations
- Discovery Laboratories, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Lucinactant
Standard Care
Arm Description
Lucinactant via bronchoaveolar lavage
Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence of Death
Number of Participants With Air Leaks
Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00004500
Brief Title
Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
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 Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment and administrative reasons
Study Start Date
March 2000 (undefined)
Primary Completion Date
November 2002 (Actual)
Study Completion Date
November 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Windtree Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meconium Aspiration
Keywords
cardiovascular and respiratory diseases, meconium aspiration syndrome, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lucinactant
Arm Type
Experimental
Arm Description
Lucinactant via bronchoaveolar lavage
Arm Title
Standard Care
Arm Type
Other
Arm Description
Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
Intervention Type
Drug
Intervention Name(s)
Lucinactant
Other Intervention Name(s)
Surfactant, KL₄Surfactant
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Care
Other Intervention Name(s)
Negative Control
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Days Receiving Mechanical Ventilation (MV)
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Incidence of Death
Time Frame
28 days
Title
Number of Participants With Air Leaks
Description
Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium
Time Frame
28 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of meconium aspiration syndrome (MAS)
Continuous mechanical ventilation (CMV) at time of entry
Enrollment within 48 hours of birth
Gestational age of ≥ 37 weeks
Oxygenation index of ≥ 5 and ≤ 30
Written informed consent signed and dated by the infant's parent(s) or legal guardian(s)
Exclusion Criteria:
Congenital anomalies likely to affect any primary or secondary endpoints
Uncontrollable air leaks
Hydrops fetalis
Rupture ≥ 3 weeks of the fetal membranes
Evidence of overwhelming bacterial infection at time of randomization
Markedly labile persistent pulmonary hypertension at time of randomization
Profound neurologic manifestations
Sustained postductal SpO₂of < 87% for ≥ 15 minutes at an FiO₂of 1.00
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas E Wiswell
Organizational Affiliation
Windtree Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
Discovery Laboratories, Inc.
City
Warrington
State/Province
Pennsylvania
ZIP/Postal Code
18976
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
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