CHLORHEXIDINE VERSUS POVIDONE-IODINE FOR SKIN ANITSEPSIS PRIOR TO CENTRAL VENOUS CATHETER INSERTION IN PRETERM INFANTS: PROTOCOL FOR A RANDOMISED TRIAL (THE SKA TRIAL) - THE SKA TRIA

niversity College Dublin0 个研究点开始时间: 2011年7月7日最近更新: 2015年2月2日

适应症

试验速览

暂无简介。

•Inclusion Criteria
•Only infants who meet all of the following inclusion criteria will be eligible for enrolment into this study:
•1. Born at < 31 weeks gestation (by best obstetric estimate)
•2. Have a central venous catheter inserted (UVC or PICC) in the neonatal intensive care unit (NICU) of one of the participating centres.
•3. Who’s parent/legal guardian are willing and able to understand and provide written, informed consent prior to their Infant’s participation in the study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 304
•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

•Infants meeting any of the following exclusion criteria are not eligible for enrolment into this study:
•1. Infants with major congenital anomalies, including but not limited to gastroschisis, diaphragmatic hernia, oesophageal atresia, omphalocoele; tracheo-oesophageal fistula; neural tube defect; structural heart lesion other than patent ductus arteriosus or small atrial or ventricular septal defect.
•2. Infants who have previously had a CVC placed at a participating or referring hospital.
•3. Infants who are participating in another clinical trial involving an investigational medicinal product.

发起方

niversity College Dublin