Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients

ONY477 enrolled

Overview

Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.

Treatment will not be masked. The study objective is to document that aerosolized Infasurf is superior to "usual care" and provides for some patients effective surfactant therapy with less need for endotracheal intubation and instillation of a surfactant suspension into the airway. Two cohorts will be recruited: (a) patients who did not receive surfactant at birth who develop RDS in the first hours of life and (b) patients who received instillation of surfactant for RDS in the first hour of life, were extubated, and have continuing RDS.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

477

Conditions

Respiratory Distress Syndrome

Interventions

Aerosolized CalfactantDRUG

Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.

SolarysDEVICE

Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.

Eligibility

Sex: ALLMin age: 1 HourMax age: 24 Hours

Medical Language ↔ Plain English

Inclusion Criteria: RDS Patients 1. NICU patient, ≥1hour of age and \<24 hours of age. 2. Clinical diagnosis of RDS, with or without chest X-ray data. 3. Inspired oxygen ≥21% to maintain adequate oxygen saturation. 4. Not intubated 5. Requiring: 1. nasal continuous positive airway pressure (nCPAP). Exclusion Criteria: 1. Congenital anomaly limiting care options or requiring early surgery. 2. Cardiopulmonary decompensation. 1. hypotension with metabolic acidosis (base excess \< -10 meq/l). 2. Oxygen saturations \< 88% at start of aerosolization. 3. PaCO2 ≥ 60 mmHg at start of aerosolization. 3. Grade 3 or Grade 4 intraventricular hemorrhage by cranial ultrasound, if known. 4. Acute hypoxic encephalopathy with or without seizures.

Locations (22)

USA Children's & Women's Hospital

Mobile, Alabama, United States

Outcomes

Primary Outcomes

Intubation and Instillation of Liquid Surfactant

Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours.

Time frame: 72 hours

Secondary Outcomes

Respiratory Support Requirements

Difference of Respiratory support at 28 days

Time frame: 28 days

Air Leak

Percent of at risk subjects with air leak at any time

Time frame: 28 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.