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Completed

NCT Number: NCT05215028

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

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.

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Key information

Conditions

Child Development Disorder Depression, Postpartum Depressive Disorder Developmental Disabilities Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Neurodevelopmental Disorders Post Partum Depression Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

Up to 3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ILC

Le Mans, 72000, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

web-application

Device

web application multi-domain familial digital health record PRO The aim is 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.

Other names: MALO

Primary outcomes

  1. impact on neurodevelopmental disorders detection

    Time frame: 3 years

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

  2. impact on hearing disorders

    Time frame: 3 years

    description of the rate and age at detection

  3. impact on visual disorders

    Time frame: 3 years

    description of the rate and age at detection

  4. impact on mandatory or recommended vaccines

    Time frame: 3 years

    rate of vaccines

  5. impact on postnatal depression

    Time frame: 3 years

    rate of women in post natal depression

Sponsors and collaborators

Lead sponsor

Weprom

Other

Collaborators

  • Kelindi

Registry information

Acronym: MALO_2

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 31, 2022
Registry last updated
Jan 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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