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

• Status: Terminated
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Windtree Therapeutics
• Treatments: Pulmonary Surfactants

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