jRCT2031240339招募中不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 14
- 主要终点
- Reduction in the incidence of severe Bronchopulmonary Dysplasia (BPD) at 36 weeks (+- 3 days) Postmenstrual Age (PMA), or death at or before 36 weeks PMA
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 23week old over 至 28week old not（—）
- 性别
- All
入选标准
- •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 underageparents must be approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) (in accordance with local regulations).
- •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).
- •Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.
排除标准
- •Detectable major (or severe) congenital malformation identified before randomization.
- •Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigators opinion.
- •Hypoglycemia at baseline (blood glucose <45 mg/dL or 2.5 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 CUS (hemorrhages confined to the germinal matrix are allowed) and investigators opinion.
- •Any other condition or therapy that, in the investigators opinion, may pose a risk to the subject or interfere with the subjects 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 subject or subjects 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.
结局指标
主要结局
Reduction in the incidence of severe Bronchopulmonary Dysplasia (BPD) at 36 weeks (+- 3 days) Postmenstrual Age (PMA), or death at or before 36 weeks PMA
时间窗: 36 weeks (+- 3 days) Postmenstrual Age (PMA)
Compared to the standard neonatal care (SNC) group
次要结局
未报告次要终点
研究者
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