The use of Sildenafil in Neonates with Down Syndrome to Reduce Pulmonary Vascular Resistance. - T21 Trial

Royal College of Surgeons in Ireland0 个研究点目标入组 40 人开始时间: 2021年8月31日最近更新: 2023年11月13日

试验速览

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•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

•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

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