Randomised Placebo-Controlled Trial of Early Targeted Treatment of Patent Ductus Arteriosus with Paracetamol in Extremely Low Birth Weight Infants (ETAPA) - ETAPA

niversity College Dublin0 个研究点目标入组 218 人开始时间: 2023年1月10日最近更新: 2024年5月27日

适应症

试验速览

暂无简介。

•- They are inborn or transferred to a participating centre after birth and have a birth weight of <1000g established by weight assessment on admission to NICU.
•- The treating doctors plan to offer them intensive care.
•- Large PDA is present on fnECHO, defined as PDA with diameter greater than 1.5mm with non-restrictive flow (defined as diastolic flow less than 50% of systolic flow), determined by targeted fnECHO between 6 and 12 hours of age.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 218
•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 with major congenital anomalies including neural tube defects, major structural cardiac anomalies (excluding PDA/ASD/PFO), abdominal wall defects and congenital diaphragmatic hernia and major dysmorphic features with an abnormal karyotype e.g. T21, T13, T18.
•- The treating clinician does not intend to offer the infant intensive care.
•- Bidirectional shunt of PDA on ECHO (defined as shunt exceeding 30% of the right to left proportion of the shunting).
•- Grade II – IV IVH on point of care CRUSS on screening (between six to twelve hours of age).
•- PH prior to study commencement.
•- Severe PPHN.
•- History or examination suggestive of liver failure prior to study commencement.
•- Written informed consent has not been obtained before the infant is 12 hours of age, or the infant’s parent(s)/guardian(s) withdraw consent prior to commencement of the trial processes or assessments.

发起方

niversity College Dublin