ISRCTN13727958已完成未知
Randomized controlled trial to assess the early addition of exogenous surfactant to inhaled nitric oxide in the treatment of newborns with respiratory failure and pulmonary hypertension
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
2020 results in https://doi.org/10.1038/s41372-020-00777-x (added 26/08/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Near term infants (35 weeks gestation) with birth weights > 2000 g and who are less than 72 hours old
- •2. Infants requiring mechanical ventilation with hypoxemic respiratory failure with an OI > 20, calculated on two consecutive measurements of post ductal arterial blood gases without acidosis (pH > 7.25) and efforts will be done to adjust ventilatory support to reach a PCO2 < 60
- •3. A previous echocardiogram will be performed to rule out a cardiac anomaly and evaluate the presence of pulmonary hypertension (a tricuspid insufficiency jet with an estimated systolic pulmonary artery pressure = 2/3 of systemic systolic arterial blood pressure and/or evidence of right-to-left shunting through foramen ovale or ductus arteriosus)
排除标准
- •1. Life-threatening congenital anomalies
- •2. Congenital heart disease
- •3. Congenital diaphragmatic hernia
- •4. Other forms of lung hypoplasia syndromes
- •5. Suspected or confirmed chromosomal abnormality
- •6. Postnatal age > 72 hours
研究者
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