Status:
TERMINATED
Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants
Lead Sponsor:
Windtree Therapeutics
Conditions:
Respiratory Distress Syndrome
Eligibility:
All Genders
15-30 years
Phase:
PHASE2
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)...
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...
Eligibility Criteria
Inclusion
- Gestational age 28-32 completed weeks, inclusive
- Placement of arterial line
- Successful initiation of nCPAP
- Informed Consent
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00807235
Start Date
January 1 2005
End Date
September 1 2005
Last Update
June 13 2012
Active Locations (1)
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1
University of California, San Diego Medical Center - Hillcrest
San Diego, California, United States, 92103