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

• ClinicalTrials.gov Identifier: NCT00004500
• Recruitment Status: Terminated
• First Posted: October 19, 1999
• Results First Posted: May 1, 2012
• Last Update Posted: May 3, 2012
• Sponsor: Windtree Therapeutics
• Information provided by (Responsible Party): Windtree Therapeutics

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.

Condition or disease	Intervention/treatment	Phase
Meconium Aspiration	Drug: Lucinactant; Other: Standard Care	Phase 3

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: up to 48 Hours (Child)
• Sexes Eligible for Study: All
• 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

Locations

United States, Pennsylvania

Discovery Laboratories, Inc.

Warrington, Pennsylvania, United States, 18976

Sponsors and Collaborators

Windtree Therapeutics

Investigators

• Study Chair: Thomas E Wiswell; Windtree Therapeutics

More Information

• 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
• 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:

Meconium Aspiration Syndrome; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Fetal Diseases; Pregnancy Complications; Infant, Newborn, Diseases; Pulmonary Surfactants; Respiratory System Agents