Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants

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ClinicalTrials.gov Identifier: NCT00807235

Recruitment Status : Terminated (Slow enrollment)

First Posted : December 11, 2008

Results First Posted : June 13, 2012

Last Update Posted : June 13, 2012

Sponsor:

Information provided by (Responsible Party):

Windtree Therapeutics

Study Description

Brief Summary:

To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.

Condition or disease	Intervention/treatment	Phase
Respiratory Distress Syndrome	Drug: Aerosolized lucinactant	Phase 2

Detailed 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


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	17 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	An Open Label, Multicenter, Phase 2, Pilot Evaluation of SURFAXIN®(Lucinactant) Delivered as an Aerosol Via Nasal Continuous Positive Airway Pressure (nCPAP) in the Prevention of Respiratory Distress Syndrome in Premature Infants
Study Start Date :	January 2005
Actual Primary Completion Date :	August 2005
Actual Study Completion Date :	September 2005

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Regimen 1	Drug: Aerosolized lucinactant Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 3 hours. Other Name: KL₄Surfactant
Experimental: Regimen 2	Drug: Aerosolized lucinactant Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 1 hour. Other Name: KL₄Surfactant

Outcome Measures

Primary Outcome Measures :

Number of Participants With Respiratory Distress Syndrome [ Time Frame: 24 hours ]

Secondary Outcome Measures :

Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂) [ Time Frame: 0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours ]
AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward
Arterial Alveolar (a/A) O₂Ratio [ Time Frame: 72 hours ]
a/A ratio is a relative way to judge the lungs ability to transport O₂. It compares the partial pressure of O₂in the alveoli (A) to the partial pressure of O₂in the artery (a). It is calculated by dividing the partial pressure of O₂in the artery, abbreviated PaO2, by the partial pressure of O₂in the alveoli using the alveolar gas equation, abbreviated PAO2. A value of 0.80 or above is normal, a value of 0.60 or below may be incompatible with spontaneous breathing, and a value below 0.22 indicates severe lung disease.
Time to Meet Failure Criteria [ Time Frame: Through 28 days ]
Failure criteria defined as rescue with bolus surfactant and mechanical ventilation
Number of Participants With Bronchopulmonary Dysplasia (BPD) [ Time Frame: 28 days ]
Number of Participants Alive and Without BPD [ Time Frame: 28 days ]
Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL) [ Time Frame: 28 days ]
Number of Participants With Patent Ductus Arteriosus (PDA) [ Time Frame: 28 days ]
Number of Participants With Necrotizing Enterocolitis (NEC) [ Time Frame: 28 days ]
Number of Participants With Pulmonary Hemorrhage [ Time Frame: 28 days ]
Number of Participants With Acquired Sepsis [ Time Frame: 28 days ]
Incidence of Mortality [ Time Frame: 28 days ]
Number of Participants With Air Leak [ Time Frame: 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	up to 30 Minutes (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Gestational age 28-32 completed weeks, inclusive
Placement of arterial line
Successful initiation of nCPAP
Informed Consent

Exclusion Criteria:

Heart rate that cannot be stabilized >100 bpm within 5 minutes of birth
Five (5) minute Apgar score ≤ 3
Major congenital malformation(s) diagnosed antenatally or noted immediately after birth
Other disease(s) or conditions potentially interfering with cardiopulmonary function
Mother with prolonged rupture of membranes > 2 weeks
Known or suspected chromosomal abnormality
Need for chest compressions or administration of epinephrine, bicarbonate, or fluid boluses in the delivery room
Need for mechanical ventilation within 30 minutes of birth

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807235

Locations


United States, California
University of California, San Diego Medical Center - Hillcrest
San Diego, California, United States, 92103

Sponsors and Collaborators

Windtree Therapeutics

Investigators


Principal Investigator:	Neil Finer, MD	University of California, San Diego

More Information

Publications of Results:

Finer NN, Merritt TA, Bernstein G, Job L, Mazela J, Segal R. An open label, pilot study of Aerosurf® combined with nCPAP to prevent RDS in preterm neonates. J Aerosol Med Pulm Drug Deliv. 2010 Oct;23(5):303-9. doi: 10.1089/jamp.2009.0758.


Responsible Party:	Windtree Therapeutics
ClinicalTrials.gov Identifier:	NCT00807235 History of Changes
Other Study ID Numbers:	KL4-CPAP-01
First Posted:	December 11, 2008 Key Record Dates
Results First Posted:	June 13, 2012
Last Update Posted:	June 13, 2012
Last Verified:	May 2012

Keywords provided by Windtree Therapeutics:


Lucinactant Nasal continuous positive airway pressure (nCPAP) Respiratory distress syndrome (RDS) Pediatric Premature

Additional relevant MeSH terms:


Syndrome Premature Birth Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Disease Pathologic Processes Obstetric Labor, Premature Obstetric Labor Complications	Pregnancy Complications Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Pulmonary Surfactants Respiratory System Agents

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