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Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants

Primary Purpose

Respiratory Distress Syndrome

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aerosolized lucinactant
Aerosolized lucinactant
Sponsored by
Windtree Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Distress Syndrome focused on measuring Lucinactant, Nasal continuous positive airway pressure (nCPAP), Respiratory distress syndrome (RDS), Pediatric, Premature

Eligibility Criteria

15 Minutes - 30 Minutes (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Diego Medical Center - Hillcrest

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Regimen 1

Regimen 2

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Respiratory Distress Syndrome

Secondary Outcome Measures

Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)
AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward
Arterial Alveolar (a/A) O₂Ratio
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
Failure criteria defined as rescue with bolus surfactant and mechanical ventilation
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Number of Participants Alive and Without BPD
Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)
Number of Participants With Patent Ductus Arteriosus (PDA)
Number of Participants With Necrotizing Enterocolitis (NEC)
Number of Participants With Pulmonary Hemorrhage
Number of Participants With Acquired Sepsis
Incidence of Mortality
Number of Participants With Air Leak

Full Information

First Posted
December 10, 2008
Last Updated
May 11, 2012
Sponsor
Windtree Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00807235
Brief Title
Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants
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 Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
January 2005 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Windtree Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
Lucinactant, Nasal continuous positive airway pressure (nCPAP), Respiratory distress syndrome (RDS), Pediatric, Premature

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regimen 1
Arm Type
Experimental
Arm Title
Regimen 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Aerosolized lucinactant
Other Intervention Name(s)
KL₄Surfactant
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Aerosolized lucinactant
Other Intervention Name(s)
KL₄Surfactant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Respiratory Distress Syndrome
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)
Description
AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward
Time Frame
0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours
Title
Arterial Alveolar (a/A) O₂Ratio
Description
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 Frame
72 hours
Title
Time to Meet Failure Criteria
Description
Failure criteria defined as rescue with bolus surfactant and mechanical ventilation
Time Frame
Through 28 days
Title
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Time Frame
28 days
Title
Number of Participants Alive and Without BPD
Time Frame
28 days
Title
Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)
Time Frame
28 days
Title
Number of Participants With Patent Ductus Arteriosus (PDA)
Time Frame
28 days
Title
Number of Participants With Necrotizing Enterocolitis (NEC)
Time Frame
28 days
Title
Number of Participants With Pulmonary Hemorrhage
Time Frame
28 days
Title
Number of Participants With Acquired Sepsis
Time Frame
28 days
Title
Incidence of Mortality
Time Frame
28 days
Title
Number of Participants With Air Leak
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Minutes
Maximum Age & Unit of Time
30 Minutes
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Finer, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego Medical Center - Hillcrest
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20455772
Citation
Finer NN, Merritt TA, Bernstein G, Job L, Mazela J, Segal R. An open label, pilot study of Aerosurf(R) 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.
Results Reference
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Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants

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