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

May 11, 2012 updated by: Windtree Therapeutics

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States, 92103
        • University of California, San Diego Medical Center - Hillcrest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 minutes to 30 minutes (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Regimen 1
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 Names:
  • KL₄Surfactant
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 Names:
  • KL₄Surfactant
EXPERIMENTAL: Regimen 2
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 Names:
  • KL₄Surfactant
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 Names:
  • KL₄Surfactant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Respiratory Distress Syndrome
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours
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.
72 hours
Time to Meet Failure Criteria
Time Frame: Through 28 days
Failure criteria defined as rescue with bolus surfactant and mechanical ventilation
Through 28 days
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Time Frame: 28 days
28 days
Number of Participants Alive and Without BPD
Time Frame: 28 days
28 days
Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)
Time Frame: 28 days
28 days
Number of Participants With Patent Ductus Arteriosus (PDA)
Time Frame: 28 days
28 days
Number of Participants With Necrotizing Enterocolitis (NEC)
Time Frame: 28 days
28 days
Number of Participants With Pulmonary Hemorrhage
Time Frame: 28 days
28 days
Number of Participants With Acquired Sepsis
Time Frame: 28 days
28 days
Incidence of Mortality
Time Frame: 28 days
28 days
Number of Participants With Air Leak
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Neil Finer, MD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ACTUAL)

August 1, 2005

Study Completion (ACTUAL)

September 1, 2005

Study Registration Dates

First Submitted

December 10, 2008

First Submitted That Met QC Criteria

December 10, 2008

First Posted (ESTIMATE)

December 11, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 13, 2012

Last Update Submitted That Met QC Criteria

May 11, 2012

Last Verified

May 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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