Feasibility Study of Surfaxin (Lucinactant) Delivered as an Aerosol Via Nasal Continuous Positive Airway Pressure (nCPAP) in the Prevention of Respiratory Distress Syndrome in Premature Infants
Summary
To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nCPAP for the prevention of RDS in premature infants.
Description
Use of a device in the early treatment of RDS that permits the effective aerosolization of an exogenous surfactant that also allows for the simultaneous delivery of continuous positive airway pressure would permit the delivery of surfactant to the distal airways without intubation. This approach could reduce the frequency of severity of the adverse events relative to endotracheal intubation and surfactant administration via bolus.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Prevention
Conditions
Respiratory Distress Syndrome
Intervention
Aerosolized lucinactant, Aerosolized lucinactant
Location
University of California San Diego Medical Center - Hillcrest
San Diego
California
United States
92103
Status
Terminated
Source
Discovery Laboratories
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00807235
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Sin Nombre Virus
A species of HANTAVIRUS which emerged in the Four Corners area of the United States in 1993. It causes a serious, often fatal pulmonary illness (HANTAVIRUS PULMONARY SYNDROME) in humans. Transmission is by inhaling aerosolized rodent secretions that contain virus particles, carried especially by deer mice (PEROMYSCUS maniculatus) and pinyon mice (P. truei).
Respiratory Distress Syndrome, Adult
A syndrome characterized by progressive life-threatening RESPIRATORY INSUFFICIENCY in the absence of known LUNG DISEASES, usually following a systemic insult such as surgery or major TRAUMA.
Bronchopulmonary Dysplasia
A chronic lung disease developed after OXYGEN INHALATION THERAPY or mechanical ventilation (VENTILATION, MECHANICAL) usually occurring in certain premature infants (INFANT, PREMATURE) or newborn infants with respiratory distress syndrome (RESPIRATORY DISTRESS SYNDROME, NEWBORN). Histologically, it is characterized by the unusual abnormalities of the bronchioles, such as METAPLASIA, decrease in alveolar number, and formation of CYSTS.
Respiratory Syncytial Virus, Bovine
A species of PNEUMOVIRUS causing an important respiratory infection in cattle. Symptoms include fever, conjunctivitis, and respiratory distress.
Hyaline Membrane Disease
A respiratory distress syndrome in newborn infants, usually premature infants with insufficient PULMONARY SURFACTANTS. The disease is characterized by the formation of a HYALINE-like membrane lining the terminal respiratory airspaces (PULMONARY ALVEOLI) and subsequent collapse of the lung (PULMONARY ATELECTASIS).
Clinical Trials
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...
OBJECTIVES: Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.
Inhaled Prostacyclin for Adult Respiratory Distress Syndrome (ARDS) and Pulmonary Hypertension
Summary of the proposed research: The intravenous application of prostacyclin (PGE1) or its stable analogue, iloprost, has been used to cause a decrease not only of the pulmonary but also...
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...
Corticosteroids as Rescue Therapy for the Late Phase of Acute Respiratory Distress Syndrome
The purpose of this study is to assess innovative treatment methods in patients with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS.
PubMed Articles
Lucinactant approved for respiratory distress syndrome.
BACKGROUND: Infections caused by extensive drug-resistant Acinetobacter baumannii (XDR-AB) have been increasingly observed and are associated with a high mortality rate. We present our experience usin...
Aerosolized prostacyclin for acute lung injury (ALI) and acute respiratory distress syndrome (ARDS).
BACKGROUND: Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are critical conditions that are associated with high mortality and morbidity. Aerosolized prostacyclin has been used...
BACKGROUND/PURPOSE: Ventilator-associated pneumonia (VAP) due to multidrug-resistant (MDR) Acinetobacter baumannii in critically ill patients presents an emerging challenge to clinicians. Administrati...
The Airways, a Novel Route for Delivering Monoclonal Antibodies to Treat Lung Tumors.
PURPOSE: Lung cancer is the leading cause of cancer-related death worldwide. The efficacy of current systemic treatments is limited, with major side effects and only modest survival improvements. Aero...
