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

NCT ID: NCT00807235

Last Updated: 2012-06-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2005-09-30

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.

Conditions

Respiratory Distress Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Regimen 1

Group Type: EXPERIMENTAL

Aerosolized lucinactant

Intervention Type: DRUG

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.

Regimen 2

Group Type: EXPERIMENTAL

Aerosolized lucinactant

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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 1 hour.

Intervention Type: DRUG

Other Intervention Names

KL₄Surfactant; KL₄Surfactant

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

• Minimum Eligible Age: 15 Minutes
• Maximum Eligible Age: 30 Minutes
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Windtree Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Finer, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University of California, San Diego Medical Center - Hillcrest

San Diego, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20455772 (View on PubMed)

Other Identifiers

KL4-CPAP-01

Identifier Type: -

Identifier Source: org_study_id