- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00807235
Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants
May 11, 2012 updated by: Windtree Therapeutics
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92103
- University of California, San Diego Medical Center - Hillcrest
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 minutes to 30 minutes (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Regimen 1
|
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 Names:
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 Names:
|
EXPERIMENTAL: Regimen 2
|
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 Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With Respiratory Distress Syndrome
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours
|
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.
|
72 hours
|
Time to Meet Failure Criteria
Time Frame: Through 28 days
|
Failure criteria defined as rescue with bolus surfactant and mechanical ventilation
|
Through 28 days
|
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Time Frame: 28 days
|
28 days
|
|
Number of Participants Alive and Without BPD
Time Frame: 28 days
|
28 days
|
|
Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)
Time Frame: 28 days
|
28 days
|
|
Number of Participants With Patent Ductus Arteriosus (PDA)
Time Frame: 28 days
|
28 days
|
|
Number of Participants With Necrotizing Enterocolitis (NEC)
Time Frame: 28 days
|
28 days
|
|
Number of Participants With Pulmonary Hemorrhage
Time Frame: 28 days
|
28 days
|
|
Number of Participants With Acquired Sepsis
Time Frame: 28 days
|
28 days
|
|
Incidence of Mortality
Time Frame: 28 days
|
28 days
|
|
Number of Participants With Air Leak
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neil Finer, MD, University of California, San Diego
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (ACTUAL)
August 1, 2005
Study Completion (ACTUAL)
September 1, 2005
Study Registration Dates
First Submitted
December 10, 2008
First Submitted That Met QC Criteria
December 10, 2008
First Posted (ESTIMATE)
December 11, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
June 13, 2012
Last Update Submitted That Met QC Criteria
May 11, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Disease
- Infant, Newborn, Diseases
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Infant, Premature, Diseases
- Syndrome
- Premature Birth
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Respiratory System Agents
- Pulmonary Surfactants
Other Study ID Numbers
- KL4-CPAP-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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