Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome
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.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Meconium Aspiration
Intervention
Lucinactant, Standard Care
Location
Discovery Laboratories, Inc.
Warrington
Pennsylvania
United States
18976
Status
Terminated
Source
Discovery Laboratories
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00004500
- Information obtained from ClinicalTrials.gov on May 29, 2012
Medical and Biotech [MESH] Definitions
Meconium Aspiration Syndrome
A condition caused by inhalation of MECONIUM into the LUNG of FETUS or NEWBORN, usually due to vigorous respiratory movements during difficult PARTURITION or respiratory system abnormalities. Meconium aspirate may block small airways leading to difficulties in PULMONARY GAS EXCHANGE and ASPIRATION PNEUMONIA.
Standard Of Care
The minimum acceptable patient care, based on statutes, court decisions, policies, or professional guidelines.
Pneumonia, Aspiration
A type of lung inflammation resulting from the aspiration of food, liquid, or gastric contents into the upper RESPIRATORY TRACT.
Respiratory Aspiration
Breathing in liquid or solids, such as stomach contents, into the RESPIRATORY TRACT. When this causes severe lung damage, it is called ASPIRATION PNEUMONIA.
Progressive Patient Care
Organization of medical and nursing care according to the degree of illness and care requirements in the hospital. The elements are intensive care, intermediate care, self-care, long-term care, and organized home care.
Clinical Trials
Surfactant Lavage vs. Bolus Surfactant in Neonates With Meconium Aspiration
The objective of this pilot study is to examine the feasibility and safety of performing a larger trial to assess outcomes following treatment of meconium aspiration syndrome with surfacta...
To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nCPAP for the prevention of RDS in premature infants.
Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old
Treatment with lucinactant, a peptide-containing synthetic lung surfactant, will be evaluated in young children with acute respiratory failure who require mechanical ventilation (life supp...
Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease
Mucus clearance is impaired in cystic fibrosis. Inhaled surfactants may reduce adhesive forces between mucus and airway surfaces and improve mucus clearance. This in turn my improve lung...
Swallowing implies the appropriate use and sufficient function of specific muscles that are also used in speech. Theoretically, if these muscles are functionally affected then phonation an...
PubMed Articles
OBJECTIVE: To evaluate the impact of suction technique on the rate of meconium removal, oxygenation, and hemodynamics in an animal experimental model of meconium aspiration syndrome (MAS). METHODS: MA...
Spectrophotometric Analysis in Umbilical Cords of Infants with Meconium Aspiration Syndrome.
We compared spectrophotometric analysis of the umbilical cords of infants with meconium aspiration syndrome (MAS) or with meconium-stained amniotic fluid (MSAF) and healthy infants. In a prospective s...
Glucocorticoids in the treatment of neonatal meconium aspiration syndrome.
Meconium aspiration syndrome is a serious neonatal disease with complex pathophysiology. With respect to the contribution of meconium-induced lung edema, inflammation and vasoconstriction on the cours...
Meconium impairs pulmonary surfactant by a combined action of cholesterol and bile acids.
Mechanisms for meconium-induced inactivation of pulmonary surfactant as part of the meconium aspiration syndrome in newborn infants, to our knowledge, are not clearly understood. Here we have studied...
PURPOSE: Meconium aspiration syndrome (MAS) is a life-threatening neonatal lung injury, whose pathophysiology has been mainly studied in animal models. In such models, pancreatic secretory phospholipa...
