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临床试验/NCT00213941
NCT00213941Unknown不适用

Study Protocol Evaluating Transient Tachypnoea of the Newborn in Term and Near Term Neonates

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2004年11月1日最近更新:
适应症

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

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

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other

研究点 (2)

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