Finding solutions to thrive after birth asphyxia in Africa: An open-label dose-finding clinical trial (Phase Ib study) - SANE-Uganda

Research Institute of the McGill University Health Centre0 个研究点目标入组 30 人开始时间: 2022年2月9日最近更新: 2023年5月29日

试验速览

暂无简介。

•Male and female neonates meeting the criteria for birth asphyxia:
•- Gestational age = 36 weeks and birth weight = 1800 g;
•- Admitted to Kawempe Hospital or Nsambya Hospital within 48 hours of life;
•- Need for continued resuscitation after birth and/or 5-minute Apgar score =5;
•- Evidence of neonatal encephalopathy by an abnormal neurological exam (modified Sarnat score of 2-3 or abnormal aEEG).

•- Absent heart rate at 10 minutes/imminent death
•- Neonates with major congenital malformations
•- Neonates with grade 3 AKI (serum creatinine rise =3x lowest previous creatinine or creatinine > 2.5 mg/dL = 221 mcmol/L or receipt of dialysis)
•- Neonates with intraventricular and/or intraparenchymal hemorrhage on cranial ultrasound (cUS) performed on day 1-2 of life
•- Mother living permanently outside 20km radius of Kawempe Hospital or Nsambya Hospital
•- Neonates whose parents are unwilling or unable to give informed written consent to enter the study

发起方

Research Institute of the McGill University Health Centre