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Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Information provided by (Responsible Party):
Windtree Therapeutics

Brief Summary:


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

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2000
Actual Primary Completion Date : November 2002
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lucinactant
Lucinactant via bronchoaveolar lavage
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

Standard Care
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Incidence of Death [ Time Frame: 28 days ]
  2. Number of Participants With Air Leaks [ Time Frame: 28 days ]
    Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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

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United States, Pennsylvania
Discovery Laboratories, Inc.
Warrington, Pennsylvania, United States, 18976
Sponsors and Collaborators
Windtree Therapeutics
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Study Chair: Thomas E Wiswell Windtree Therapeutics
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Responsible Party: Windtree Therapeutics
ClinicalTrials.gov Identifier: NCT00004500    
Other Study ID Numbers: KL4-MAS-03
FD-R-001938 ( Other Grant/Funding Number: US Department of Health and Human Services )
First Posted: October 19, 1999    Key Record Dates
Results First Posted: May 1, 2012
Last Update Posted: May 3, 2012
Last Verified: May 2012
Keywords provided by Windtree Therapeutics:
cardiovascular and respiratory diseases
meconium aspiration syndrome
rare disease
Additional relevant MeSH terms:
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Meconium Aspiration Syndrome
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Fetal Diseases
Pregnancy Complications
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents