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

Phase 2TerminatedNCT00807235

Windtree Therapeutics17 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Respiratory Distress Syndrome

Interventions

Aerosolized lucinactantDRUG

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 lucinactantDRUG

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.

Eligibility

Sex: ALLMin age: 15 MinutesMax age: 30 Minutes

Medical Language ↔ Plain English

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

Locations (1)

University of California, San Diego Medical Center - Hillcrest

San Diego, California, United States

Outcomes

Primary Outcomes

Number of Participants With Respiratory Distress Syndrome

Time frame: 24 hours

Secondary Outcomes

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

Time frame: 0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours

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.

Time frame: 72 hours

Time to Meet Failure Criteria

Failure criteria defined as rescue with bolus surfactant and mechanical ventilation

Time frame: Through 28 days

Number of Participants With Bronchopulmonary Dysplasia (BPD)

Time frame: 28 days

Number of Participants Alive and Without BPD

Time frame: 28 days

Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)

Time frame: 28 days

Number of Participants With Patent Ductus Arteriosus (PDA)

Data from ClinicalTrials.gov

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