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临床试验/NCT05215028
NCT05215028已完成不适用

Optimization of Mother-child Dyad Follow-up by a Multidomain Application: Real-world Cross Sectional Study

Weprom1 个研究点 分布在 1 个国家目标入组 4,346 人开始时间: 2021年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4,346
试验地点
1
主要终点
impact on hearing disorders

研究概览

简要总结

After birth, the mother-child dyad can be impacted by issues which are usually under-detected or detected at early stage. Among these issues, neurodevelopmental disorders (NDD) such as autism spectrum disorder are common and affect 1 in 59 children but are detected after 4 years of age although it could be detected using parent report screens as early as 12 or 18 months of age. Moreover, parents are the main contributors of the screening of NDD in their children. In a recent French survey, the identification of the first symptoms was done by parents in 61% of cases and a health professional in only 14% and the mean age of disease detection was 6.8 years for autism spectrum disorder.

Other troubles that deserve early screening are hearing disorders which are observed in 1 child in 300 at 3 years of age and the main visual trouble in toddlers such as amblyopia which is observed with a prevalence of 3%.

Another issue that deserves improvement is the rate of mandatory or recommended vaccines in toddler which is only 71% for C-meningococcus and 79% for measles or rubella.

Concerning the mother, postnatal depression is defined as an episode of minor or major depression occurring during the first year postpartum with a pooled prevalence of 17.7%. Despite the high prevalence of this disorder and its potential impact on child development it remains underdetected and undertreated in daily practice.

The common point between all these disorders is that they can benefit from early detection by questionnaires intended for parents for their children or for themselves, because early treatment improves prognosis or prevent diseases.

An "all-in-one" multi-domain familial digital health record Patient reported outcomes application has been developing to help for early screening of neurodevelopmental disorders of toddler after birth to 3 years of age and mother's postnatal depression, to improve vaccinations rate of toddlers and to provide advice to parents for child development. The aim of the study is to assess in a real-world data-based the performances of this application.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
— 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Parent of child or more under 3 years of age
  • User of application Malo

排除标准

  • Parent of a child who has already been diagnosed with a developmental disorder, known physical or mental disability

结局指标

主要结局

impact on hearing disorders

时间窗: 3 years

description of the rate and age at detection

impact on postnatal depression

时间窗: 3 years

rate of women in post natal depression

impact on neurodevelopmental disorders detection

时间窗: 3 years

description of the rate and age at detection of each type of neurodevelopmental desorder

impact on visual disorders

时间窗: 3 years

description of the rate and age at detection

impact on mandatory or recommended vaccines

时间窗: 3 years

rate of vaccines

次要结局

未报告次要终点

研究者

发起方
Weprom
申办方类型
Other
责任方
Sponsor

研究点 (1)

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