A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
Study on Preventing Bronchopulmonary Dysplasia in Premature Infants
Anna Elizabeth Thomas
Primary Investigator
Brief description of study
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.
THIS STUDY IS ENROLLING BY INVITATION ONLY
Detailed description of study
Participants will be included in one of the following groups:
Group 1: Experimental Drug OHB-607 - Participants will receive continuous IV infusion of OHB-607 through from birth up to PMA 29 weeks +6 days.
Group 2: No Intervention - Standard Neonatal Care
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Intraventricular Hemorrhage, Retinopathy of Prematurity (ROP)
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Age: 23 weeks - 27 weeks
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Gender: All
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
This study investigates bronchopulmonary dysplasia in extremely premature infants. Bronchopulmonary dysplasia is a serious lung condition that affects infants, particularly those born prematurely, causing breathing problems. The purpose of this study is to determine if an investigational medication can prevent this condition when compared to standard neonatal care.
Participants in the study will receive different treatments. One group will receive an investigational medication through an IV infusion from birth until they reach a certain age. The other group will receive standard neonatal care without additional intervention. The study aims to observe the effects of these treatments on the infants' lung health.
- Who can participate: Infants born between 23 and 27 weeks of gestation are eligible. Exclusions include major congenital malformations and specific maternal infections.
- Study details: Participants will be in two groups: one receiving an investigational medication through IV and the other receiving standard neonatal care. No placebo is used.
