A Phase 2b, Multicenter, Randomized, Open-label, Controlled, 3-Arm Study to Evaluate the Clinical Efficacy and Safety of SHP607 in Preventing Chronic Lung Disease Through 12 Months Corrected Age Compared to Standard Neonatal Care in Extremely Premature Infants

ishizawa Atsushi0 个研究点目标入组 81 人开始时间: 2020年12月25日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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 institutional review board (IRB)/independent ethics committee (IEC).
•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.
•3. Initially, participants must be between gestational age (GA) of 26 weeks +0 days and 27 weeks +6 days, inclusive. After approximately 75 participants (approximately 25 participants in each treatment group) have completed the postmenstrual age (PMA) 40 weeks visit, an independent data monitoring committee (DMC) will assess safety data and may authorize enrollment of participants of GA between 23 weeks +0 days and 27 weeks +6 days, inclusive.

•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 drug, device, or procedure (participation in observational 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.

发起方

ishizawa Atsushi