Erythropoietin for the repair of cerebral injury in very preterm infants, a randomized, double-blind, placebo-controlled, prospective, and multicenter clinical study

niversitätsSpital Zürich0 个研究点目标入组 120 人开始时间: 2015年10月16日最近更新: 2016年2月1日

试验速览

暂无简介。

•- Informed written parental consent
•- IVH (grade II-IV)
•- GA < 32 0/7 weeks and/or BW < 1’500 g at birth. (Comment: There is a steep rise in the incidence of IVH with decreasing GA and decreasing BW)
•?- Chronological age < 8 d. (Comment: More than 96% of all cases of IVH happen within the first 5 d of life. In contrast, IVH in term infants is a rare event and follows a rather different clinical course.)
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 120
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Genetically defined syndrome
•- Severe congenital malformation adversely affecting life expectancy or neurodevelopment
•- Admitted a priori for palliative care
•- Unlikely to participate at 5-year follow-up examination
•- Lack of willingness to storage and disclosure of pseudonymous disease data in the context of the clinical trial;
•- patients enrolled in this EPO-repair study are not allowed to receive EPO for other purposes;

发起方

niversitätsSpital Zürich