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

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

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

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
United States, California | |
University of California, San Diego Medical Center - Hillcrest | |
San Diego, California, United States, 92103 |
Principal Investigator: | Neil Finer, MD | University of California, San Diego |
Publications of Results:
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 |