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NCT03253263 · ClinicalTrials.gov registry record · Phase 2
A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
A Phase 2 study of Bronchopulmonary Dysplasia and Intraventricular Hemorrhage, sponsored by OHB Neonatology.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 338
- Enrollment target
- 20
- Study locations
NCT03253263 is a Phase 2 study of Bronchopulmonary Dysplasia and Intraventricular Hemorrhage that is actively recruiting participants, run by OHB Neonatology. The registered enrollment target is 338 participants, above the 225-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (50% higher). The trial reports 20 study locations across 13 states.
The verdict
NCT03253263, a Phase 2 study of Bronchopulmonary Dysplasia and Intraventricular Hemorrhage, is actively recruiting participants, sponsored by OHB Neonatology.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 338 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone.
Conditions Studied
Interventions
- DRUG OHB-607
Study Locations (20)
Arkansas
- Arkansas Children's Hospital - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
California
- Children's Hospital of Orange County - California City
- LAC USC Medical Center - Los Angeles
Florida
- Jackson Memorial Hospital - Miami
- Tampa General Hospital - Tampa
Indiana
- Riley Hospital for Children - Indianapolis
- Memorial Hospital of South Bend - South Bend
Massachusetts
- Tufts Medical Center - Boston
- Boston Children's Hospital - Boston
Minnesota
- Children's Minnesota - Children's Hospital and Clinics - St. Paul - Saint Paul
- Children's Minnesota - Children's Hospital and Clinics - Saint Paul
New York
- University of Rochester - Rochester
- Maria Fareri Children's Hospital - Valhalla
Illinois
- University of Illinois at Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 338 participants |
| Start Date | 2019-05-09 |
| Est. Completion | 2028-01-21 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03253263
The ClinicalTrials.gov registry entry for NCT03253263 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 338 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 225-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (50% higher). The listed sponsor is OHB Neonatology, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Bronchopulmonary Dysplasia appearing as the primary indexed condition, and to 1 intervention - of which OHB-607 is the first listed.
NCT03253263 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Arkansas, California, Florida.
Frequently Asked Questions
What is clinical trial NCT03253263 about?
NCT03253263 is a clinical study titled "A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants". The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone.
What is the current status of trial NCT03253263?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 338 participants. The study started on 2019-05-09. Estimated completion is 2028-01-21.
What conditions does trial NCT03253263 study?
This clinical trial studies the following conditions: Bronchopulmonary Dysplasia, Intraventricular Hemorrhage, Retinopathy of Prematurity (ROP), Chronic Lung Disease of Prematurity.
What interventions are being tested in trial NCT03253263?
The interventions under investigation include: OHB-607 (DRUG).
Who is sponsoring clinical trial NCT03253263?
This trial is sponsored by OHB Neonatology, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03253263 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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