Clinical trial NCT00807235: Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Respiratory Distress Syndrome
Keywords: Lucinactant
Nasal continuous positive airway pressure (nCPAP)
Respiratory distress syndrome (RDS)
Pediatric
Premature
Lead sponsor: Windtree Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-12-11
Enrollment: 17
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Respiratory Distress Syndrome
timeFrame: 24 hours
Secondary outcomes:
measure: Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)
timeFrame: 0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours
measure: Arterial Alveolar (a/A) O₂Ratio
timeFrame: 72 hours
measure: Time to Meet Failure Criteria
timeFrame: Through 28 days
measure: Number of Participants With Bronchopulmonary Dysplasia (BPD)
timeFrame: 28 days
measure: Number of Participants Alive and Without BPD
timeFrame: 28 days
measure: Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)
timeFrame: 28 days
measure: Number of Participants With Patent Ductus Arteriosus (PDA)
timeFrame: 28 days
measure: Number of Participants With Necrotizing Enterocolitis (NEC)
timeFrame: 28 days
measure: Number of Participants With Pulmonary Hemorrhage
timeFrame: 28 days
measure: Number of Participants With Acquired Sepsis
timeFrame: 28 days
measure: Incidence of Mortality
timeFrame: 28 days
measure: Number of Participants With Air Leak
timeFrame: 28 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego Medical Center - Hillcrest
state: California
Study officials:
affiliation: University of California, San Diego
name: Neil Finer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Finer NN, Merritt TA, Bernstein G, Job L, Mazela J, Segal R. An open label, pilot study of Aerosurf(R) combined with nCPAP to prevent RDS in preterm neonates. J Aerosol Med Pulm Drug Deliv. 2010 Oct;23(5):303-9. doi: 10.1089/jamp.2009.0758.