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

Launched by OHB NEONATOLOGY LTD. · Aug 15, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called OHB-607, which aims to help prevent a serious lung condition known as Bronchopulmonary Dysplasia (BPD) in extremely premature infants. BPD is a common problem for babies born very early, and it can lead to long-term breathing difficulties. The trial will compare the effects of this investigational drug with the standard care that these infants usually receive in the hospital.

To participate, infants must be between 23 and 27 weeks old at birth and meet certain health criteria. For example, they should not have severe birth defects or certain serious health issues. Parents will need to provide written consent before their baby can join the study. If enrolled, families can expect close monitoring of their baby's health throughout the trial period. This research is important because it could lead to better treatments for premature infants, reducing the chances of developing chronic lung problems later in life.

Gender

ALL

Eligibility criteria

• 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.