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A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age

NCT04264156 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-05-24

Study results available
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Summary

This study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by the incidence of and time to respiratory failure and/or death due to RDS in the first 72 hours and 28 days of life. Half of the subjects will receive lucinactant for inhalation and half will receive standard of care (nCPAP alone).

Conditions

  • Respiratory Distress Syndrome, Newborn

Interventions

COMBINATION_PRODUCT

Lucinactant for Inhalation

A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nasal continuous positive airway pressure (nCPAP).

OTHER

nCPAP Only

Nasal continuous positive airway pressure (nCPAP) alone

Sponsors & Collaborators

  • Windtree Therapeutics

    lead INDUSTRY

Principal Investigators

  • Carlos Guardia, MD · Windtree Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Minutes
Max Age
6 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-18
Primary Completion
2021-01-31
Completion
2021-03-28
FDA Drug
Yes
FDA Device
Yes

Countries

  • Poland

Study Locations

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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 NCT04264156 on ClinicalTrials.gov