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临床试验/NCT03860142
NCT03860142已完成不适用

Evolution of Food Orality in Children Aged Between 24 and 36 Months: Comparison of the Severity and Specificities of Disorders Between Two Populations of Children, Born Very Prematurely and Born at Term

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2018年11月30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
79
试验地点
1
主要终点
Archet scale score

研究概览

简要总结

Oral disorders are currently widely described in the premature birth population, but few studies compare them to their prevalence in the full-term population.

In addition, new behaviours and eating habits are regularly emerging in our society.

The objective of this study is to compare the severity of signs of oral disorders between the group of preterm infants and the group of term infants born without organic pathologies that compromise oral development.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
24 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children whose age ≥ 24 months and ≤ 36 months
  • Full-term or prematurely born (<33 SA) at Nice University Hospital

排除标准

  • Children with congenital pathologies (with malformations in the oro-facial sphere)
  • Children with neurological and developmental pathologies unrelated to prematurity
  • Children with ENT deformities
  • Parental langage barrier

结局指标

主要结局

Archet scale score

时间窗: 15 mn

The severity of the signs of food orality disorders is assessed by Archet Scale, which makes it possible to establish a score out of 20. The severity of the signs is divided into four classes according to the following scores: from 0 to 5 = zero to low grade, from 6 to 10 = light grade, from 11 to 15 = moderate grade, from 16 to 20 = severe grade

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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