OBJECTIVES:

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

Condition	Treatment or Intervention	Phase
Meconium Aspiration	Drug: Lucinactant	Phase III

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.

Ages Eligible for Study:  up to  2 Days,  Genders Eligible for Study:  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

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

Study chairs or principal investigators

Thomas E Wiswell,  Study Chair,  Discovery Laboratories   

Study ID Numbers:  199/14367; ATI-FDR001424
Record last reviewed:  February 2001
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004500
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09