Outcome After Selective Early Treatment for Closure of Patent Ductus Arteriosus in Pre-term Babies - Baby-OSCAR Trial

niversity of Oxford0 个研究点目标入组 730 人开始时间: 2015年6月12日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•Babies will be considered eligible for inclusion into the study if they are;
•Born at 23+0 to 28+6 weeks of gestation
•Less than 72 hours old
•Confirmed by echocardiography to have a large PDA which
•oIs = 1.5 mm in diameter (determined by gain optimised colour Doppler)
•oHas unrestrictive pulsatile left to right flow
•In addition:
•The responsible clinician is uncertain about whether this baby might benefit from treatment to close the PDA
•Written informed consent has been obtained from the parent(s)
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Babies will be excluded from participation in the study if they have;
•No realistic prospect of survival
•Severe congenital anomaly
•Structural heart disease requiring treatment
•Other conditions that would contraindicate the use of ibuprofen (intracranial or gastrointestinal haemorrhage, coagulopathy, thrombocytopenia (platelet count <50,000), renal failure, pulmonary hypertension, known or suspected necrotising enterocolitis)
•Antenatal treatment with a COX inhibitors
•Received indomethacin, ibuprofen or paracetamol after birth.

发起方