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

Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00807235
• Other study ID #: KL4-CPAP-01
• Status: Terminated
• Phase: Phase 2
• First received: December 10, 2008
• Last updated: May 11, 2012
• Start date: January 2005
• Est. completion date: September 2005

Study information

• Verified date: May 2012
• Source: Discovery Laboratories, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: September 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Minutes

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• Aerosolized lucinactant
Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 3 hours.
• Aerosolized lucinactant
Aerosolized lucinactant via nCPAP over 3 hours. Up to 3 retreatments will be allowed over a 48 hour period with each retreatment separated by at least 1 hour.

Locations

Country	Name	City	State
United States	University of California, San Diego Medical Center - Hillcrest	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Discovery Laboratories, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Finer NN, Merritt TA, Bernstein G, Job L, Mazela J, Segal R. An open label, pilot study of Aerosurf® 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Respiratory Distress Syndrome		24 hours	No
Secondary	Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO2)	AUC for FiO2calculated using the trapezoidal rule. Missing data imputed using last observation carried forward	0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours	No
Secondary	Arterial Alveolar (a/A) O2Ratio	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.	72 hours	No
Secondary	Time to Meet Failure Criteria	Failure criteria defined as rescue with bolus surfactant and mechanical ventilation	Through 28 days	No
Secondary	Number of Participants With Bronchopulmonary Dysplasia (BPD)		28 days	No
Secondary	Number of Participants Alive and Without BPD		28 days	No
Secondary	Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)		28 days	No
Secondary	Number of Participants With Patent Ductus Arteriosus (PDA)		28 days	No
Secondary	Number of Participants With Necrotizing Enterocolitis (NEC)		28 days	No
Secondary	Number of Participants With Pulmonary Hemorrhage		28 days	No
Secondary	Number of Participants With Acquired Sepsis		28 days	No
Secondary	Incidence of Mortality		28 days	No
Secondary	Number of Participants With Air Leak		28 days	Yes