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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:
Information provided by (Responsible Party):
Discovery Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00807235
First received: December 10, 2008
Last updated: May 11, 2012
Last verified: May 2012
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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:


Further study details as provided by Discovery Laboratories, Inc.:

Primary Outcome Measures:
  • Number of Participants With Respiratory Distress Syndrome [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
    AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward

  • Arterial Alveolar (a/A) O₂Ratio [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Failure criteria defined as rescue with bolus surfactant and mechanical ventilation

  • Number of Participants With Bronchopulmonary Dysplasia (BPD) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Number of Participants Alive and Without BPD [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Number of Participants With Patent Ductus Arteriosus (PDA) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Number of Participants With Necrotizing Enterocolitis (NEC) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Number of Participants With Pulmonary Hemorrhage [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Number of Participants With Acquired Sepsis [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Incidence of Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Number of Participants With Air Leak [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Discovery Laboratories, Inc.
Investigators
Principal Investigator: Neil Finer, MD University of California, San Diego
  More Information

Publications:
Responsible Party: Discovery Laboratories, Inc.
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
Health Authority: United States: Food and Drug Administration

Keywords provided by Discovery Laboratories, Inc.:
Lucinactant
Nasal continuous positive airway pressure (nCPAP)
Respiratory distress syndrome (RDS)
Pediatric
Premature

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Syndrome
Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Pulmonary Surfactants
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014