Co-administration of Acetaminophen with Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants – The ACEDUCT Trial

Royal College Of Surgeons In Ireland0 个研究点目标入组 310 人开始时间: 2023年4月5日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•1.Preterm infants born <27+0 weeks gestational age admitted to one of four study NICUs: Mount Sinai Hospital, Sunnybrook Health Sciences Centre, McMaster Children’s Hospital, or the Rotunda Hospital, 2.Permission given by the attending clinician to approach and then consent obtained from parents, 3.Diagnosis of PDA = 1.5 mm on echocardiography with unrestrictive predominantly left to right shunt, 4.Designated to receive first treatment course with intravenous or enteral ibuprofen, as decided by the attending team.

•1.Chromosomal anomaly, 10.Cases of severe hepatocellular insufficiency., 2.Pre-treatment renal dysfunction defined as urine output < 1ml/kg/hour for the previous 24 hours or serum creatinine > 100 micromol/L, 3.Pre-treatment hepatic dysfunction defined as serum aminotransferase (ALT) > 100 units/L94, 4.Platelet count <50,000 per microliter and no plan to transfuse platelets, 5.Permission denied by the attending clinician to approach parents, 6.Parental consent not available, 7.Previous exposure to PDA medical treatment with any drug (prophylactic indomethacin use for prevention of intraventricular hemorrhage will not be considered as PDA treatment)., 8.Use of any other investigational medicinal product within previous 30 days, 9.Any other medical condition/or treatment that contraindicates treatment with paracetamol or ibuprofen, such ashypersensitivity to paracetamol, propacetamol hydrochloride, or to any of the excipients listed in Section 6.1 of the SmPC for Paracetamol 10mg/ml solution for infusion

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