A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants

Running, not enrolling · Phase 2

Conditions studied: Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Intraventricular Hemorrhage, Retinopathy of Prematurity (ROP)

In brief

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.

Key facts

Study ID

NCT03253263

Run by

OHB Neonatology Ltd.

People needed

295

Starts

2019-05-09

Expected to finish

2028-01-21

Last updated by the study team

2026-08-03

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• 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).
• Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.

You may not qualify if…

• Detectable major (or severe) congenital malformation identified before randomization.
• Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion.
• 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.
• Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion.
• 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.
• 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).
• 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.
• Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.
• Birth mother with known HIV or hepatitis (B, C, or E) infection.

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Children's Hospital of Orange County — California City, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• US Davis — Sacramento, California, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Memorial Hospital of South Bend — South Bend, Indiana, United States
• University of Louisville Hospital — Louisville, Kentucky, United States
• Ochsner Baptist Medical Center — New Orleans, Louisiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Children's Minnesota - Children's Hospital and Clinics - St. Paul — Saint Paul, Minnesota, United States
• Children's Minnesota - Children's Hospital and Clinics — Saint Paul, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• University of Rochester — Rochester, New York, United States
• Maria Fareri Children's Hospital — Valhalla, New York, United States
• Oklahoma Children's Hospital - PIN — Oklahoma City, Oklahoma, United States
• Medical University of South Carolina Children Hospital — Charleston, South Carolina, United States
• Texas Children's Hospital — Houston, Texas, United States
• UT Health Science Center — San Antonio, Texas, United States
• UVA Children's Hospital — Charlottesville, Virginia, United States
• Virginia Commonwealth University - Children's Hospital of Richmond at VCU — Richmond, Virginia, United States
• Royal Hospital for Women — Randwick, New South Wales, Australia
• Arkansas Children's Hospital — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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