Study Protocol Evaluating Transient Tachypnoea of the Newborn in Term and Near Term Neonates
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Evaluate and compare the accuracy of different tests at initial evaluation in predicting a complicated course in neonae with TTN
研究概览
简要总结
Transient tachypnoea of the newborn (TTN) is a common cause of hospitalisation in the neonatal period, complicating 1 to 1,5 per cent life birth. Predisposing factors are prematurity, birth after C section, especially before the onset of labor. The main factor leading to this condition is a lack of absorption of the fluid contained in the alveolar space resulting in an early respiratory distress which normally resolves in two to five days with oxygen supplementation.
Meanwhile, some neonates will experience a complicated evolution requiring ventilatory support and hospitalisatioon in neonatal intensive care unit. This complication is not preventable and could result either of a surfactant deficiency (primary or secondary) or a persistent pulmonary hypertension of the neonate (PPHN).
In this study, a cohort of newborn presenting TTN will be followed, in order to evaluate, at initial admission, pulmonary maturation (with fetal lung maturity test and the stable microbubble test) and to seek for PPHN (echochardiography). Therapeutic management will be done according to standard care and classification of the neonate will be performed according to their clinical evolution: group 1 (uncomplicated TTN) and group 2 (complicated TTN).
Statistical analysis will compare results of the tests at initial evaluation in the two groups, and accuracy of the tests to predict a complicated evolution will be established.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 6 Hours(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonate > or = 34 weeks GA admitted in the first 6 hours of life with the suspected diagnosis of TTN (respiratory rate > 60/mn, SpO2 < 90% in room air, ilvermann score > 0
- •Parental consent obtained
排除标准
- •GA> 42 weeks
- •meconial amniotic fluid
- •early onset neonatal sepsis (septic shock)
- •congenital malformations
- •enteral feeding started before admission
- •no parental consent
结局指标
主要结局
Evaluate and compare the accuracy of different tests at initial evaluation in predicting a complicated course in neonae with TTN
次要结局
- Increase the knowledge in the physiopathology of TTN
