Management of Hypotension In the Preterm: A multi centre, randomised, controlled trial of hypotension management in the extremely low gestational age newborn - HIP Trial

BrepCo Biopharma Limited0 个研究点目标入组 340 人开始时间: 2013年1月10日最近更新: 2022年3月14日

试验速览

暂无简介。

•Gestational age from 23 weeks at birth to less than 28 completed weeks (i.e. up to and including 27 weeks and 6 days).
•Within 72 hours of birth.
•An indwelling arterial line, suitably calibrated and zeroed, to monitor blood pressure with the measuring dome at the level of the mid axillary line when supine.
•A pre-trial cranial ultrasound scan free of grade III-IV IVH or cystic PVL.
•A mean blood pressure (BP) 1 mmHg or more below a mean BP value equivalent to the GA in completed weeks, which persists over a 15 minute period.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 340
•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

•Infant is considered non-viable by attending clinicians.
•Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosus) and chromosomal abnormalities. Infants known to require surgical treatment e.g. congenital diaphragmatic hernia, tracheoesophageal fistula, omphalocele, gastroschisis. Hydrops Fetalis.
•Parenchymal haemorrhage or a grade III IVH (where over 50% of the ventricle is filled with blood).

发起方