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

Phase 2

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Regimen 1	Aerosolized lucinactant	-
Regimen 2	Aerosolized lucinactant	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Respiratory Distress Syndrome	24 hours

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)	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
Arterial Alveolar (a/A) O₂Ratio	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.
Time to Meet Failure Criteria	Through 28 days	Failure criteria defined as rescue with bolus surfactant and mechanical ventilation
Number of Participants With Bronchopulmonary Dysplasia (BPD)	28 days
Number of Participants Alive and Without BPD	28 days
Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)	28 days
Number of Participants With Patent Ductus Arteriosus (PDA)	28 days
Number of Participants With Necrotizing Enterocolitis (NEC)	28 days
Number of Participants With Pulmonary Hemorrhage	28 days
Number of Participants With Acquired Sepsis	28 days
Incidence of Mortality	28 days
Number of Participants With Air Leak	28 days