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

NCT03058666 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 477

Last updated 2024-05-29

Study results available
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Summary

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

Conditions

  • Respiratory Distress Syndrome

Interventions

DRUG

Aerosolized Calfactant

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

DEVICE

Solarys

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

Sponsors & Collaborators

  • ONY

    lead INDUSTRY

Principal Investigators

  • James Cummings, MD · Albany Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-29
Primary Completion
2018-06-01
Completion
2018-07-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03058666 on ClinicalTrials.gov