The Evaluation of Safety and Tolerability of CL2020 in Neonatal Hypoxic Ischemic Encephalopathy Patients with Therapeutic Hypothermia in the Dose Escalation Clinical Trial - SHIELD Trial

Sato Yoshiaki0 个研究点目标入组 12 人开始时间: 2020年2月6日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) At least 36 weeks gestation, and either one of the following criteria (i.-iii.)
•i. Apgar score of 5 or less at 10 minutes
•ii. Continued resuscitation for at least 10 minutes
•iii. pH of less than 7.0 or base deficit of 16 or more mmol/L in any blood sample obtained within 60 min of birth
•2) Moderate or severe encephalopathy by a Sarnat criteria
•3) Undergone therapeutic hypothermia started before six hours of birth, and done for 72 hours coutinuously
•4) Birth weight of 1,800g or more
•5) Heart rate of 100 or more/min, and SpO2 of 90 % or more
•6) Able to provide voluntary written consent after receiving adequate information about the study (consent will be obtained from an acceptable representative)

•1) Suspected or confirmed severe congenital abnormalities or chromosomal anomaly
•2) Planned to undergo surgery or radiation therapy
•3) Scheduled to take systemic corticosteroids treatment for over five days
•4) Blood glucose of 200 or more mg/dL
•5) Participation in another clinical study (not exclude patienets in observational studies)
•6) Suspected or confirmed active and severe infection
•7) Positive for HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody or syphilis serum reaction
•8) History of severe hypersensitivity or anaphylactic reaction
•9) Severe complications

发起方

Sato Yoshiaki