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临床试验/NCT04703946
NCT04703946已完成不适用

Ankyloglossia in Neonates. Incidence of Short Sublingual Frenulum in Newborns at the Hospital Nostra Senyora de Meritxell. Relationship With Auxological Data, Associated Malformations or Diseases and Hereditary Component of the Newborn.

Universitat Internacional de Catalunya1 个研究点 分布在 1 个国家目标入组 2,167 人开始时间: 2018年1月1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
2,167
试验地点
1
主要终点
Ankilloglosia

研究概览

简要总结

The aim of the study was to analyze the incidence of short sublingual frenulum in newborns of the Hospital Nostra Senyora de Meritxell of the Principat of Andorra.

详细描述

Thus, the objective of this study was to determine the incidence of AG in newborns of the Hospital Nostra Senyora de Meritxell of the Principat of Andorra, as well as the relationship with auxological data, associated malformations or diseases and hereditary component of the newborn.

A random sample of 2167 individuals is enough to estimate, with a confidence of 95% and an accuracy of +/- 1 percentage units, a population percentage that is projected to be around 6%. The percentage of replenishment required is projected to be 0%. With this sample, it will be sufficient to estimate the children who have ankyloglossia, the % of relatives who also have it (a population percentage that is projected to be around 25%). Confidential and anonymous collection of data from patients' medical records for a period of 2 years and 8 months, and write them down in a database to finally correlate them and see if there is any association with the parameters studied.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
1 Minute 至 2 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • The inclusion criteria are patients born from July 2018 to February 2021 (both inclusive) and of both genders.

排除标准

  • The exclusion criteria are all those who were born abroad and who after 24 hours go to the Hospital of Andorra, those urgently transferred to other foreign centers after birth, as well as those who present medical records with lack of information.

结局指标

主要结局

Ankilloglosia

时间窗: 2 weeks

presence or absence of Ankilloglosia

次要结局

  • type of short frenulum(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Francisco Guinot-Jimeno

Jefe departamento de odontopedaitria

Universitat Internacional de Catalunya

研究点 (1)

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