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

This study has been terminated.

Sponsors and Collaborators:	FDA Office of Orphan Products Development Discovery Laboratories
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004500

Purpose

OBJECTIVES:

I. Determine the safety and efficacy of lucinactant in full term newborn infants with meconium aspiration syndrome.

Condition	Intervention	Phase
Meconium Aspiration	Drug: Lucinactant	Phase III

Drug Information available for: Lucinactant Sinapultide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	200
Study Start Date:	November 2000

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 2 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of meconium aspiration syndrome with respiratory distress and meconium staining at birth, in airways, or in bronchial secretions, in which there is no other major cause for respiratory distress

Conventional intermittent mandatory ventilation

At least 37 weeks gestational age

--Patient Characteristics--

Renal: No oligohydramnios with renal dysgenesis

Cardiovascular: No congenital cyanotic heart disease

Pulmonary: No airway anomalies; No lung hypoplasia; No pulmonary hemorrhage; No pulmonary interstitial emphysema, uncontrollable air leaks, pneumothorax, pneumomediastinum, or pneumopericardium; Oxygenation index at least 5 and no greater than 30 on a single arterial blood gas reading within 60 minutes prior to study; No diaphragmatic hernia

Neurologic: No known grade III or IV intraventricular hemorrhage; No obvious CNS abnormalities or malformations

Other: No hydrops fetalis immune and nonimmune; No prolonged (at least 3 weeks) rupture of the fetal membranes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004500

Locations

United States, Pennsylvania
Discovery Laboratories, Inc.
Doylestown, Pennsylvania, United States, 18901

Sponsors and Collaborators

FDA Office of Orphan Products Development

Discovery Laboratories

Investigators

Study Chair:

Thomas E Wiswell

Discovery Laboratories

More Information

Study ID Numbers:	199/14367, ATI-FDR001424
Study First Received:	October 18, 1999
Last Updated:	January 4, 2008
ClinicalTrials.gov Identifier:	NCT00004500
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

cardiovascular and respiratory diseases
meconium aspiration syndrome
rare disease

Study placed in the following topic categories:

Fetal Diseases
Meconium Aspiration Syndrome
Pregnancy Complications
Respiratory Tract Diseases

Lung Diseases
Respiration Disorders
Rare Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on January 16, 2009