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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

December 10, 2008
December 11, 2008
April 2, 2012
June 13, 2012
June 13, 2012
January 2005
August 2005   (Final data collection date for primary outcome measure)
Number of Participants With Respiratory Distress Syndrome [ Time Frame: 24 hours ]
Respiratory Distress Syndrome [ Time Frame: 24 hours ]
Complete list of historical versions of study NCT00807235 on ClinicalTrials.gov Archive Site
  • 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 ]
  • AUC for FiO2 [ Time Frame: 72 hours ]
  • a/A O2 ratios [ Time Frame: 72 hours ]
  • Time to meet failure criteria (rescue with bolus surfactant and mechanical ventilation) [ Time Frame: 72 hours ]
  • Incidence of: IVH (PVL), pulmonary hemorrhage, NEC, PDA, Sepsis, BPD, Alive without BPD, mortality and air leak. [ Time Frame: 28 days ]
Not Provided
Not Provided
 
Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants
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.
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.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Respiratory Distress Syndrome
  • 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
  • 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
  • Experimental: Regimen 1
    Intervention: Drug: Aerosolized lucinactant
  • Experimental: Regimen 2
    Intervention: Drug: Aerosolized lucinactant
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
Same as current
September 2005
August 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 30 Minutes   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00807235
KL4-CPAP-01
No
Not Provided
Not Provided
Windtree Therapeutics
Windtree Therapeutics
Not Provided
Principal Investigator: Neil Finer, MD University of California, San Diego
Windtree Therapeutics
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP