What is OHB-607 studying for Bronchopulmonary Dysplasia?

OHB-607 is being studied to see if it can prevent Bronchopulmonary Dysplasia, a common chronic lung disease in extremely premature infants. Researchers want to know if this drug reduces the risk of severe lung disease or death compared to standard neonatal care. The study is sponsored by OHB Neonatology Ltd.

Who may be eligible for this Bronchopulmonary Dysplasia clinical trial?

Infants born between 23 weeks 0 days and 27 weeks 6 days gestational age may be eligible, with no major congenital malformations or significant neurological disease. The birth mother must also be free from active COVID-19 or severe infection history. This trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this Bronchopulmonary Dysplasia clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants can expect to receive medical care and monitoring without charge during the study.

Actively Recruiting

Phase 2

Age: 0Hours - 24Hours

All Genders

ID03253263

A Phase 2b Study Evaluating OHB-607 Compared to Standard Neonatal Care to Prevent Bronchopulmonary Dysplasia in Extremely Premature Infants

Led by OHB Neonatology Ltd. · Updated on 2026-01-07

338

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating an investigational drug called OHB-607 to prevent Bronchopulmonary Dysplasia BPD, a common chronic lung disease in extremely premature infants. The study compares infants receiving OHB-607 to those receiving standard neonatal care to see if the drug can reduce the incidence of severe BPD or death by 36 weeks postmenstrual age. This is a Phase 2b, randomized, open-label study involving infants born between 23 weeks 0 days and 27 weeks 6 days gestational age. Participants in the trial will be randomly assigned to one of two groups. One group will receive a continuous intravenous infusion of OHB-607 from birth until 29 weeks and 6 days postmenstrual age. The other group will receive standard neonatal care without the investigational drug. This approach allows researchers to compare the effects of OHB-607 against routine care practices for preventing lung disease in these infants. During the study, infants will be closely monitored through 36 weeks postmenstrual age and up to 24 months corrected age. Researchers will assess lung health, including the incidence and severity of BPD, time to weaning off respiratory support, and other complications such as intraventricular hemorrhage and retinopathy of prematurity. Developmental outcomes will also be measured using standardized scales at 24 months corrected age. Safety assessments and long-term follow-up are included to understand the drugs effects over time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0Hours - 24Hours

All Genders

Eligibility Criteria

You may qualify if you...

Written informed consent must be signed by the participant's parent(s) before any study procedures.
Written informed consent must be signed by the participant's birth mother before providing birth-related medical information.
Infants must be born between 23 weeks 0 days and 27 weeks 6 days gestational age, inclusive.

You will not qualify if you...

Major or severe congenital malformations detected before randomization.
Known or suspected chromosomal abnormalities, genetic disorders, or syndromes before randomization.
Persistent hypoglycemia at baseline despite glucose supplementation.
Clinically significant neurological disease identified by cranial ultrasound, excluding germinal matrix hemorrhages.
Any condition or therapy that poses a risk or may interfere with compliance or results.
Participation in another investigational clinical study treatment, device, or procedure.
Inability to comply with the study protocol or likely unavailability for long-term follow-up.
Birth mother with active COVID-19 infection at birth or severe COVID-19 history requiring intensive care during pregnancy.
Birth mother with known HIV or hepatitis B, C, or E infection.

Research Team

OHB Contact

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