The use of milrinone in neonates with persistent pulmonary hypertension of the newborn: a randomised controlled trial pilot study

The Royal College of Surgeons in Ireland0 个研究点目标入组 9 人开始时间: 2015年7月7日最近更新: 2022年11月28日

适应症

试验速览

•All infants with a gestation = 34 weeks and a birth weight = 2000 grams admitted to the neonatal intensive care unit with a clinical diagnosis of PPHN, and commenced on iNO will be deemed potentially eligible for this study. The process of iNO initiation in PPHN on clinical grounds is standardised in the NICUs. In addition, the infants must satisfy the following criteria:
•1. = 10 postnatal days of life and within 24 hrs of admission
•2. Echocardiography diagnosis of PPHN (see below)
•3. Absence of significant congenital heart defect excluding a small atrial septal defect or ventricular septal defect (measuring less than 3mm)
•4. Indwelling arterial line; oxygenation index =25 on at least two consecutive arterial blood gas samples at least 20 minutes apart

•1. Lethal congenital anomalies or obvious syndrome
•2. Bleeding diathesis (abnormal coagulation screen/platelet <100,000/ mm3)
•3. The presence of Intraventricular haemorrhage
•4. Diastolic Hypotension (defined as a diastolic blood pressure less than the 3rd centile for any given gestation) unresponsive to medical treatment (=30 mL/kg fluid bolus and = 2 inotropes of at least 10 µg/ kg/min)
•5. Hypoxic-ischemic encephalopathy undergoing therapeutic hypothermia
•6. Evidence of renal impairment (Creatinine > 100micromol/l)
•7. Severe Hypovolaemia: Heart rate > 180, capillary refill > 5 seconds, urine output < 0.5ml/kg/hour, in addition to diastolic hypotension mentioned above

发起方

The Royal College of Surgeons in Ireland