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

Study Description

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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

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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

Arms and Interventions

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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

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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
2. 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.
3. Time to Meet Failure Criteria [ Time Frame: Through 28 days ]
   Failure criteria defined as rescue with bolus surfactant and mechanical ventilation
4. Number of Participants With Bronchopulmonary Dysplasia (BPD) [ Time Frame: 28 days ]
5. Number of Participants Alive and Without BPD [ Time Frame: 28 days ]
6. Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL) [ Time Frame: 28 days ]
7. Number of Participants With Patent Ductus Arteriosus (PDA) [ Time Frame: 28 days ]
8. Number of Participants With Necrotizing Enterocolitis (NEC) [ Time Frame: 28 days ]
9. Number of Participants With Pulmonary Hemorrhage [ Time Frame: 28 days ]
10. Number of Participants With Acquired Sepsis [ Time Frame: 28 days ]
11. Incidence of Mortality [ Time Frame: 28 days ]
12. Number of Participants With Air Leak [ Time Frame: 28 days ]

Eligibility Criteria

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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