NL-OMON50767招募中3 期
ewborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: ;an international randomized controlled trial - CoDiNOS trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 11（—）
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
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, • iNO already started for postnatal transport
研究者
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