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临床试验/NCT04841070
NCT04841070已完成不适用

NEURodevelopmental Outcome in Children Between One and Five Years After Persistent Pulmonary Hypertension Of the Newborn

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2021年7月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
Describe the association between the occurrence of neuro-psychomotor developmental disorders and initial management in resuscitation.

研究概览

简要总结

Neonatal pulmonary hypertension is a rare but serious condition resulting from a lack of adaptation to extra-uterine life in some newborns. In the short term, the risk of death requires rapid and appropriate management of this transient pathology.

In the long term, these newborns present a greater brain vulnerability, a consequence of the pathology itself with cerebral hypoxia but also invasive and aggressive therapies. Although current scientific evidence indicates a correlation with the existence of neurological developmental disorders, the understanding of the long-term neurological outcome of these babies remains poorly documented. Better knowledge of remote neuro-psychomotor development of the critical period

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
1 Year 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All parenting authority holders of children aged 1 to 5 years, born after 34 weeks of amenorrhea and having been cared for neonatal PAH in paediatric resuscitation

排除标准

  • Holders of parental authority who cannot answer the questionnaire because they do not speak French.
  • Opposition of one of the two holders of parental authority
  • Minor parental authority holders
  • Holders of parental authority under safeguarding of justice, guardianship or guardianship
  • Newborns with neonatal PAH with an associated diagnosis of diaphragmatic hernia or cyanogenic congenital heart disease
  • Newborns with neonatal PAH not treated with nitrogen monoxide

结局指标

主要结局

Describe the association between the occurrence of neuro-psychomotor developmental disorders and initial management in resuscitation.

时间窗: Between one and 5 years after hospitalization in resuscitation.

Parents will complete ASQ3. The investigators will consider neuro-psychomotor developmental disorders in children with pathological ASQ questionnaire on at least 2 items.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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