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Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants
This study has been terminated.
(Slow enrollment)
Sponsor:
Windtree Therapeutics
Information provided by (Responsible Party):
Windtree Therapeutics
ClinicalTrials.gov Identifier:
NCT00807235
First received: December 10, 2008
Last updated: May 11, 2012
Last verified: May 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Respiratory Distress Syndrome | Drug: Aerosolized lucinactant | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Respiratory Distress Syndrome, Infant
Acute Respiratory Distress Syndrome
U.S. FDA Resources
Further study details as provided by Windtree Therapeutics:
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 ]
| Enrollment: | 17 |
| Study Start Date: | January 2005 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| 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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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807235
Please refer to this study by its ClinicalTrials.gov identifier: 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:
| Responsible Party: | Windtree Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00807235 History of Changes |
| Other Study ID Numbers: |
KL4-CPAP-01 |
| Study First Received: | December 10, 2008 |
| Results First Received: | April 2, 2012 |
| Last Updated: | May 11, 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 |
ClinicalTrials.gov processed this record on August 18, 2017