EUCTR2017-000421-13-IT进行中（未招募）1 期
ewborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: an international randomized controlled trial - CoDiNOS 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
- 330
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
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria in the first week of life:
- •1) Diagnosis of CDH and pulmonary hypertension defined as 2 of the following 4 criteria:
- •I. Systolic PAP> 2/3 systemic systolic pressure estimated by echocardiography
- •II. RV dilatation/septal displacement, RV dysfunction +/- LV dysfunction
- •III. Pre-post ductal SpO2 difference > 10%
- •IV. OI>20.
- •2) Parental informed consent
- •3) Children born at or after a gestational age of 34 weeks
- •4) Newborns who received a foetal intervention may be included
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •-Severe chromosomal anomaly, like trisomy 18 or trisomy 13, which may imply a decision to stop or not to start life-saving medical treatment
- •-Severe cardiac anomaly, expected to need corrective surgery in the first 60 days of life (such as transposition of the great arteries, truncus arteriosus, coarctation aortae or double outlet right ventricle)
- •-Renal anomalies associated with oligohydramnios
- •-Severe orthopaedic and skeletal deformities, which are likely to influence thoracic, and / or lung development (such as chest wall deformities and spine anomalies)
- •-Severe anomalies of the central nervous system
- •-Patients born in another centre, transported with iNO
- •-Exclusion criteria as defined in paragraph 4.3 of the SPC of sildenafil and paragraph 4.3 of iNO. For infants the relevant exclusion criteria are severe hepatic failure, allergy for components of the elements used in sildenafil, the use of strong CYP3A4-inhibitors such as intraconazol and the presence of a severe intracardiac shunt.
研究者
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