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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
Sponsor:
Information provided by (Responsible Party):
Windtree Therapeutics

Tracking Information
First Submitted Date  ICMJE October 18, 1999
First Posted Date  ICMJE October 19, 1999
Results First Submitted Date  ICMJE April 2, 2012
Results First Posted Date  ICMJE May 1, 2012
Last Update Posted Date May 3, 2012
Study Start Date  ICMJE March 2000
Actual Primary Completion Date November 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2012)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00004500 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2012)
  • 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 Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Meconium Aspiration
Intervention  ICMJE
  • Drug: Lucinactant
    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.
    Other Names:
    • Surfactant
    • KL₄Surfactant
  • 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
Study Arms  ICMJE
  • Experimental: Lucinactant
    Lucinactant via bronchoaveolar lavage
    Intervention: Drug: Lucinactant
  • Standard Care
    Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
    Intervention: Other: Standard Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 2, 2012)
69
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
200
Actual Study Completion Date  ICMJE November 2004
Actual Primary Completion Date November 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 48 Hours   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00004500
Other Study ID Numbers  ICMJE KL4-MAS-03
FD-R-001938 ( Other Grant/Funding Number: US Department of Health and Human Services )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Windtree Therapeutics
Study Sponsor  ICMJE Windtree Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Thomas E Wiswell Windtree Therapeutics
PRS Account Windtree Therapeutics
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP