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

This study has been terminated.
(Slow enrollment and administrative reasons)
Sponsor:
Information provided by (Responsible Party):
Discovery Laboratories
ClinicalTrials.gov Identifier:
NCT00004500
First received: October 18, 1999
Last updated: May 1, 2012
Last verified: May 2012
History of Changes
  Purpose

OBJECTIVES:

Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.


Condition Intervention Phase
Meconium Aspiration
 Drug: Lucinactant
Other: Standard Care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Discovery Laboratories:

Primary Outcome Measures:
  • Number of Days Receiving Mechanical Ventilation (MV) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Number of Participants With Air Leaks [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium


Enrollment: 69
Study Start Date: March 2000
Study Completion Date: November 2004
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004500

Locations
United States, Pennsylvania
Discovery Laboratories, Inc.
Warrington, Pennsylvania, United States, 18976
Sponsors and Collaborators
Discovery Laboratories
Investigators
Study Chair: Thomas E Wiswell Discovery Laboratories
  More Information

No publications provided

Responsible Party: Discovery Laboratories
ClinicalTrials.gov Identifier: NCT00004500     History of Changes
Other Study ID Numbers: KL4-MAS-03, FD-R-001938
Study First Received: October 18, 1999
Results First Received: April 2, 2012
Last Updated: May 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Discovery Laboratories:
cardiovascular and respiratory diseases
meconium aspiration syndrome
rare disease

Additional relevant MeSH terms:
Meconium Aspiration Syndrome
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Fetal Diseases
 Pregnancy Complications
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013