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

Inclusion Criteria:

1. Written informed consents and/or assents must be signed and dated by theparticipant's parent(s) prior to any study related procedures. The informed consentand any assents for underage parents must be approved by the IRB/IEC (in accordancewith local regulations).

2. Written informed consents and/or assents must be signed and dated by theparticipant's birth mother prior to providing study-related information related tobirth mother medical history, pregnancy and the birth of the participant. Theinformed consent and any assents for underage birth mothers must be approved by theIRB/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 beforerandomization.

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 glucosesupplementation, to exclude severe congenital abnormalities of glucose metabolism.

4. Clinically significant neurological disease identified before randomizationaccording to cranial ultrasound (hemorrhages confined to the germinal matrix areallowed) and investigator's opinion.

5. Any other condition or therapy that, in the investigator's opinion, may pose a riskto the participant or interfere with the participant's potential compliance withthis protocol or interfere with interpretation of results.

6. Current or planned participation in a clinical study of another investigationalstudy treatment, device, or procedure (participation in non-interventional studiesis permitted on a case-by-case basis).

7. The participant or participant's parent(s) is/are unable to comply with the protocolor is unlikely to be available for long-term follow-up as determined by theinvestigator.

8. Birth mother with active COVID-19 infection at birth or a history of severe COVID-19infection (requiring intensive care hospitalization) during pregnancy.