A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
Condition(s) studied
Investigational drug(s) / intervention(s)
OHB-607: Participants will receive intravenous infusion of OHB-607 from birth up to PMA 29 weeks + 6 days.
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.
Eligibility
Primary outcome measure(s)
- Reduction in the incidence of severe Bronchopulmonary Dysplasia (BPD) at 36 weeks (±3 days) Postmenstrual Age (PMA), or death at or before 36 weeks PMA, whichever comes first as compared to the SNC group. — Baseline through 36 weeks postmenstrual age (PMA)
Severe BPD is defined by the modified NICHD severity grading
Trial sites (62)
| Facility | City | Region | Status |
|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | |
| Children's Hospital of Orange County | California City | California | |
| Cedars Sinai Medical Center | Los Angeles | California | |
| US Davis | Sacramento | California | |
| Jackson Memorial Hospital | Miami | Florida | |
| Tampa General Hospital | Tampa | Florida | |
| University of Illinois at Chicago | Chicago | Illinois | |
| Riley Hospital for Children | Indianapolis | Indiana | |
| Memorial Hospital of South Bend | South Bend | Indiana | |
| University of Louisville Hospital | Louisville | Kentucky | |
| Ochsner Baptist Medical Center | New Orleans | Louisiana | |
| Tufts Medical Center | Boston | Massachusetts | |
| Children's Minnesota - Children's Hospital and Clinics - St. Paul | Saint Paul | Minnesota | |
| Children's Minnesota - Children's Hospital and Clinics | Saint Paul | Minnesota | |
| University of Mississippi Medical Center | Jackson | Mississippi | |
| University of Rochester | Rochester | New York | |
| Maria Fareri Children's Hospital | Valhalla | New York | |
| Oklahoma Children's Hospital - PIN | Oklahoma City | Oklahoma | |
| Medical University of South Carolina Children Hospital | Charleston | South Carolina | |
| Texas Children's Hospital | Houston | Texas | |
| UT Health Science Center | San Antonio | Texas | |
| UVA Children's Hospital | Charlottesville | Virginia | |
| Virginia Commonwealth University - Children's Hospital of Richmond at VCU | Richmond | Virginia | |
| Royal Hospital for Women | Randwick | New South Wales | |
| Westmead Hospital | Westmead | New South Wales | |
| Royal Women's Hospital | Parkville | Australia | |
| Mater Misericordiae Limited | South Brisbane | Australia | |
| Sainte Justine Hospital | Montreal | Quebec | |
| Oulun Yliopistollinen Sairaala | Oulu | Finland | |
| Universitatsklinikum Leipzig | Leipzig | Saxony | |
| Klinikum Nürnberg | Nuremberg | Germany | |
| Cork University Maternity Hospital | Cork | Wilton | |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | Lombardy | |
| Azienda Ospedaliera Di Padova | Padova | Veneto | |
| Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale | Florence | Italy | |
| Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e | Genova | Italy | |
| Presidio Ospedaliero Di Treviso Ca' Foncello | Treviso | Italy | |
| Nagano Children's Hospital | Azumino | Nagano | |
| Kurashiki Central Hospital | Kurashiki-shi | Okayama-ken |
+ 22 more sites — see the full list on the official registry below.
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03253263 on ClinicalTrials.gov ↗ ← All trials in Italy