A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 Compared to Standard Neonatal Care for the Prevention of Bronchopulmonary Dysplasia, the Most Common Cause of Chronic Lung Disease of Prematurity - OHB-607-202

OHB Neonatology Ltd0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

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•1. Written informed consents and/or assents must be signed and dated by the
•subject'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
•subject's birth mother prior to providing study-related information related to
•birth mother medical history, pregnancy and the birth of the subject. 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.

•Incidence of severe BPD (as defined by the modified NICHD severity grading) for
•all subjects at 36 weeks PMA. The definitions for BPD are based upon the
•modified NICHD guidelines for preterm infants born at <32 weeks GA:
•No BPD: oxygen for <28 days or none.
•Mild BPD: a need for oxygen for >=28 days but on room air at 36 weeks PMA.
•Moderate BPD: oxygen for >=28 days plus treatment with <30% oxygen at 36 weeks
•Severe BPD: oxygen for >=28 days plus oxygen >30% or positive pressure, or
•high flow nasal cannula >=2 L/minute at 36 weeks PMA.

发起方