Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
Information source: FDA Office of Orphan Products Development
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Meconium Aspiration
Intervention: Lucinactant (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: FDA Office of Orphan Products Development Official(s) and/or principal investigator(s):
Thomas E Wiswell, Study Chair, Affiliation: Discovery Laboratories
Summary
OBJECTIVES:
I. Determine the safety and efficacy of lucinactant in full term newborn infants with
meconium aspiration syndrome.
Clinical Details
Study design: Treatment, Randomized, Active Control, Single Group Assignment, Safety/Efficacy Study
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
Minimum age: N/A.
Maximum age: 2 Days.
Gender(s): Both.
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
Locations and Contacts
Discovery Laboratories, Inc., Doylestown, Pennsylvania 18901, United States; Recruiting
Thomas E Wiswell, Phone: 215-340-4699
Additional Information
Starting date: November 2000
Last updated: June 23, 2005
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