DRKS00013730招募中2 期
Oral Propranolol for prevention of thresholdretinopathy of prematurity - ROPROP
Charité Campus Charité Mitte0 个研究点目标入组 0 人开始时间: 2018年1月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 35 Days 至 104 Days（—）
- 性别
- All
入选标准
- •Preterm infant born before 28 weeks gestation
- •Birth weight below 1250 g
- •Alive at 5 weeks of age
- •Postmenstrual age 310/7 – 36 6/7 weeks
- •Ophthalmoscopic evidence of incipient ROP (stage 1 or 2, with or without plus disease)
- •Written informed consent by parents or legal guardian, including saving and propagation of pseudonymous medical data for study purposes, according to national requirements
排除标准
- •ROP stage 3 at time of inclusion (endpoint already reached)
- •Thyrotoxicosis, arterial hypertension or congenital heart diseases requiring open-label propranolol treatment (such as tetralogy of Fallot, paroxysmal supraventricular tachycardia,
- •or long QT syndrome)
- •Atrio-ventricular block grade 2 or 3 (contraindication for propranolol)
- •Sinuatrial block (contraindication for propranolol)
- •Uncontrolled heart failure or cardiogenic shock (contraindication for propranolol)
- •Acute severe infection (inclusion may be postponed until infection has resolved)
- •Bronchial asthma
- •Major congenital malformations or known chromosomal anomalies
- •Colobomas and other eye malformations
- •PHACE syndrome (posterior fossa anomalies, large infantile hemangiomas of the face, neck, and/or scalp, arterial lesions, cardiac abnormalities/coarctation of the aorta, eye anomalies) (risk of cerebrovascular complications)
- •Very large hemangioma (risk of hyperkalemia), as judged by the attending physician
- •Heart rate consistently (>1 h) < 100/min
- •Noninvasive mean arterial pressure consistently (>1 h)
- •Medication of the infant or the mother if breastfeeding with clonidine, reserpine, angiotensin-converting enzyme inhibitors, angiotensin-receptor antagonists, antiarrhythmic
- •drugs including amiodarone, propafenone, lidocaine, digoxin/digitoxin, quinidine, verapamil, diltiazem, or bepridil (pharmacodynamic interaction)
- •Medication of the infant with rifampicin or phenobarbitone (enhanced metabolic clearance)
- •Concurrent treatment with insulin (risk of hypoglycemia)
- •Severe liver dysfunction (GPT > 900 U/L)
- •Chronic kidney impairment (creatinine > 1.3 mg/dl [100 µM])
- •Persistent hypoglycemia (blood glucose < 36 mg/dl [2.0 mM] in 3 consecutive samples immediately preceding enrollment)
- •Persistent hyperkalemia (venous serum potassium > 5.9 mM in 3 consecutive samples immediately preceding enrollment)
- •Persistent neutropenia (absolute neutrophil counts <1,000/µL in 3 consecutive samples immediately preceding enrollment)
- •Known hypersensitivity to propranolol or any of the excipients
- •Prinzmetal’s angina, Raynaud’s phenomenon (severe peripheral arterial circulatory disturbance), or pheochromocytoma (contraindications for propranolol in adults, not occurring in newborn infants)
- •Participation in another pharmacological interventional clinical trial
- •Any circumstances that make the investigator believe that participation in the study leads to exceptional medical or organizational problems for the patient.
研究者
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