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

Meconium Aspiration Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00004500
• Other study ID #: KL4-MAS-03
• Secondary ID: FD-R-001938
• Status: Terminated
• Phase: Phase 3
• First received: October 18, 1999
• Last updated: May 1, 2012
• Start date: March 2000
• Est. completion date: November 2004

Study information

• Verified date: May 2012
• Source: Discovery Laboratories, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 69
• Est. completion date: November 2004
• Est. primary completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 48 Hours

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meconium Aspiration
• Meconium Aspiration Syndrome

Intervention

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:
• 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

Locations

Country	Name	City	State
United States	Discovery Laboratories, Inc.	Warrington	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Discovery Laboratories, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of Death		28 days	No
Secondary	Number of Participants With Air Leaks	Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium	28 days	Yes