2024-511338-10-01招募中2 期
Oral propranolol for prevention of threshold retinopathy of prematurity
Universitaetsklinikum Tuebingen AöR, Universität Zürich - Klinik für Neonatologie8 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Survival without threshold ROP (stage 3 or more severe ROP(including aggressive posterior ROP))
研究概览
简要总结
To assess the safety and efficacy of orally administered propranolol to reduce the risk of threshold retinopathy of prematurity in extremely preterm infants
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Preterm infant born before 28 weeks gestation
- •Birth weight below 1250 g
- •Alive at 5 weeks of age
- •Postmenstrual age 31 0/7 – 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)
- •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) <40 mmHg
- •Medication of the infant or the mother if breastfeeding with clonidine, reserpine, angiotensin-converting enzyme inhibitors, angiotensinreceptor antagonists, or 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)
- •Thyrotoxicosis, arterial hypertension or congenital heart diseases requiring open-label propranolol treatment (such as tetralogy of Fallot, paroxysmal supraventricular tachycardia, or long QT syndrome)
- •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
- •Lack of willingness to storage and disclosure of pseudonymous disease data in the context of the clinical trial
- •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
结局指标
主要结局
Survival without threshold ROP (stage 3 or more severe ROP(including aggressive posterior ROP))
Survival without threshold ROP (stage 3 or more severe ROP(including aggressive posterior ROP))
次要结局
- Survival without ROP treated with ablative laser surgery or intravitreal VEGF antagonists
研究者
Axel Franz
Scientific
Universitaetsklinikum Tuebingen AöR
研究点 (8)
Loading locations...
相似试验
招募中
2 期
Oral Propranolol for prevention of thresholdretinopathy of prematurityH35.1Retinopathy of prematurityDRKS00013730Charité Campus Charité Mitte
招募中
2 期
Oral Propranolol for Prevention of Threshold Retinopathy of PrematurityRetinopathy of PrematurityNCT03083431University of Zurich276
尚未招募
2 期
Prophylactic prednisolone for the prevention of early and intermediate adverse effects of radioactive iodine therapy in patients with thyroid cancer: a single centre, phase II/III, randomized, double blinded, placebo controlled clinical trial.Differentiated Thyroid cancerSLCTR/2020/009Faculty of Medicine, University of Colombo
已完成
不适用
Prevention of blindness in preterm infantsCTRI/2013/11/004131ONE52
已完成
3 期
Effect of propranolol in retinopathyRetinopathy of prematurityIRCT20100520003982N1Yazd University of Medical Sciences60