EUCTR2021-004600-17-IE进行中（未招募）1 期
The use of Sildenafil in Neonates with Down Syndrome to Reduce Pulmonary Vascular Resistance. - T21 Trial
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Antenatal or postnatal diagnosis of Down Syndrome in babies born from a singleton pregnancy at =35 weeks gestation.
- •2.Babies with a diagnosis of pulmonary hypertension, defined as two or more of the following echocardiography markers being present: (1) A PAAT < 40ms, (2) a PAAT:RVET < 0.25, (3) in the presence of a patent ductus arteriosus (PDA), the demonstration of bidirectional flow across the vessel or right to left flow; or (4) A left ventricular eccentricity index > 1.8.
- •3.Must live within 60 minutes by car or 50km of hospital
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •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
排除标准
- •1.Lack of parental consent
- •2.Congenital heart disease other than a Patent Ductus Arteriosus
- •3.Other major congenital anomaly (such as gastrointestinal issues such as duodenal atresia, or renal or liver issues).
- •4.The presence of heart block or pre-excitation on a rhythm strip
- •5.Hypotension
- •6.Abnormal liver function tests at screening
- •7.Treatment with any of the following drugs: nitric oxide donors, nitrates, guanyl cyclase inhibitors (e.g. riociguat), potent CYP 3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir), alpha-blockers, vitamin K antagonists or bosentan.
- •8.History of a persistent bleeding disorder
- •9.Close family history of hereditary degenerative retinal disorders (such as retinitis pigmentosa) or sickle cell disease
- •10.Participation in another clinical trial of an investigational medicinal product within 30 days
- •11.Presence of any other illness or condition that renders the patient unsuitable for trial participation in the opinion of the investigator
- •12.Allergy or hypersensitivity to any of the components of Sildenafil
- •13.Any reason in the opinion of the investigator that the parent(s) would be unable to administer the investigational medicinal product to the subject
研究者
相似试验
已完成
3 期
Effect of Sildenafil on the clinical course of newborns with transient tachypnea of newbornsewborns with transient tachypnea of newborns.Transient tachypnea of newborns (TTN)IRCT20161206031269N2Ahvaz University of Medical Sciences80
已完成
2 期
PK Study of Sildenafil in NeonateNeonates and Preterm InfantsNCT02244528Seoul National University Hospital20
已完成
1 期
Sildenafil Administration to Treat Neonatal EncephalopathyNeonatal EncephalopathyNCT02812433McGill University Health Centre/Research Institute of the McGill University Health Centre28
已完成
1 期
Pharmacokinetics of Sildenafil in Premature InfantsPersistent Pulmonary Hypertension of the NewbornNCT01670136University of North Carolina, Chapel Hill34
进行中（未招募）
不适用
Pilot study on the short-term effects of Sildenafil on hemodynamic response to exercise and exercise capacity in Fontan patients - NDMedDRA version: 6.1Level: PTClassification code 10045545congenital heart diseaseEUCTR2007-002688-28-ITAZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI