EUCTR2017-000421-13-NL进行中（未招募）1 期
ewborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxideversus intravenous Sildenafil:an international randomized controlled trial - CoDiNOS trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
- 入组人数
- 90
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
- •Diagnosis of CDH and pulmonary hypertension defined as 2 of the
- •following 4 criteria:
- •I. PAP> 2/3 systemic pressure estimated by echocardiography
- •II. RV dilatation/septal displacement, RV dysfunction +/- LV
- •dysfunction
- •III. Pre-post ductal SpO2 difference > 10%
- •IV. OI>20.
- •Parental informed consent
- •Children born at or after a gestational age of 34 weeks
- •Newborns who received a fetal intervention may be included
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 90
- •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
研究者
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