Bronchopulmonary DysplasiaChronic Lung Disease of PrematurityIntraventricular HemorrhageRetinopathy of Prematurity (ROP)
Investigational drug(s) / intervention(s)
OHB-607
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
Sex
ALL
Min age
0 Hours
Max age
24 Hours
Healthy volunteers
No
Inclusion Criteria:
1. Written informed consents and/or assents must be signed and dated by the participant's parent(s) prior to any study related procedures. The informed consent and any assents for underage parents must be approved by the IRB/IEC (in accordance with local regulations).
2. Written informed consents and/or assents must be signed and dated by the participant's birth mother prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the participant. The informed consent and any assents for underage birth mothers must be approved by the IRB/IEC (in accordance with local regulations).
3. Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.
Exclusion Criteria:
1. Detectable major (or severe) congenital malformation identified before randomization.
2. Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion.
3. Hypoglycemia at Baseline (blood glucose less than (\<) 45 milligrams per deciliter \[mg/dL\] or 2.5 milli moles per liter \[mmol/L\]) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism.
4. Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion.
5. Any other condition or therapy that, in the investigator's opinion, may pose a risk to the participant or interfere with the participant's potential compliance with this protocol or interfere with interpretation of results.
6. Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis).
7. The participant or participant's parent(s) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator.
8. Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.
9. Birth mother with known HIV or hepatitis (B, C, or E) infection.
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.
Official registry record
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.
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