Inhaled Treatment for Bronchopulmonary Dysplasia
NCT04619602 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2025-08-22
Summary
The primary objective of this study is to provide expanded access of S-nitrosylation therapy for the treatment of bronchopulmonary dysplasia
Conditions
- Bronchopulmonary Dysplasia
Interventions
- DRUG
-
GSNO
Intervention will be 30 minutes of inhaled GSNO agent in enrollment blocks of three subjects/dose (0.5 mL/kg of 0.25 mM, 0.5 mM, or 1 mM) to infants.
Sponsors & Collaborators
-
University Hospitals Cleveland Medical Center
lead OTHER
Principal Investigators
-
Thomas Raffay, MD · University Hospitals Cleveland Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 29 Days
- Max Age
- 365 Days
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-01
- Primary Completion
- 2025-09-01
- Completion
- 2025-09-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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