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

Stopped early · Phase 2

Conditions studied: Respiratory Distress Syndrome

In brief

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.

Key facts

Study ID

NCT00807235

Run by

Windtree Therapeutics

People needed

17

Starts

2005-01-01

Expected to finish

2005-09-01

Last updated by the study team

2012-06-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gestational age 28-32 completed weeks, inclusive
• Placement of arterial line
• Successful initiation of nCPAP
• Informed Consent

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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