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

NCT00004500 | Terminated Phase 3 Results DMC

• 2 other identifiers: KL4-MAS-03FD-R-001938
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Meconium Aspiration

Keywords

cardiovascular and respiratory diseases; meconium aspiration syndrome; rare disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Incidence of Death

  28 days

• Number of Participants With Air Leaks

  28 days

Study Arms (2)

Lucinactant

EXPERIMENTAL

Lucinactant via bronchoaveolar lavage

Drug: Lucinactant

Standard Care

OTHER

Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization

Other: Standard Care

Interventions

Lucinactant DRUG

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.

Also known as: Surfactant, KL₄Surfactant

Lucinactant

Standard Care OTHER

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

Also known as: Negative Control

Standard Care

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Windtree Therapeutics: lead

Study Sites (1)

Discovery Laboratories, Inc.

Warrington, Pennsylvania, 18976, United States

Location

MeSH Terms

Conditions

Meconium Aspiration Syndrome; Respiratory Tract Diseases; Rare Diseases

Interventions

lucinactant; Surface-Active Agents; Standard of Care

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiration Disorders; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Early termination led to a small number of subjects analyzed. Results should be interpreted with caution.

Results Point of Contact

• Title: Dr. Robert Segal
• Organization: Discovery Laboratories, Inc.

rsegal@discoverylabs.com

215-488-9300

Study Officials

• Thomas E Wiswell

  Windtree Therapeutics

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: March 1, 2000
• Primary Completion: November 1, 2002
• Study Completion: November 1, 2004
• Last Updated: May 3, 2012
• Results First Posted: May 1, 2012

Record last verified: 2012-05

Locations

US (1)