Clinical trial NCT05215028: Optimization of Mother-child Dyad Follow-up by a Multidomain Application: Real-world Cross Sectional Study
Official title: Optimization of Mother-child Dyad Follow-up by a Multidomain Application: Real-world Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Development Disorder
Post Partum Depression
Lead sponsor: Weprom
Sponsor class: OTHER
Collaborators: name: Kelindi
First posted: 2022-01-31
Enrollment: 4346
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population includes all users of the Malo application, who did not object to the use of their data over the period from 11/11/2021 to 01/07/2022.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: impact on neurodevelopmental disorders detection
timeFrame: 3 years
measure: impact on hearing disorders
timeFrame: 3 years
measure: impact on visual disorders
timeFrame: 3 years
measure: impact on mandatory or recommended vaccines
timeFrame: 3 years
measure: impact on postnatal depression
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Le Mans
country: France
facility: ILC
Study officials:
affiliation: ILC
name: Fabrice DENIS, Pr
role: PRINCIPAL_INVESTIGATOR
References: