- A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants — Recruiting • Phase II • Respiratory / COPD / Asthma • NCT03253263.
- What is being tested: OHB-607, an investigational drug designed to prevent Bronchopulmonary Dysplasia (BPD) in extremely premature infants, evaluated against standard neonatal care alone to determine its efficacy and safety profile.
- Patient eligibility overview: The study targets extremely premature infants (typically.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.
- : 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.