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CompletedNCT05215028MALO_2Updated Jan 31, 2022

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

An observational study in Child Development Disorder and Post Partum Depression, sponsored by Weprom. Completed at 1 site in France. Open to participants aged Up to 3 Years. Per ClinicalTrials.gov, last updated 2022-01-31.

Sponsored by Weprom · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
4,346
Ages
Up to 3 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Child Development Disorder
  • Post Partum Depression
03

In context

Depression, Postpartum

528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.

This study's enrollment of 4,346 is above the median of 200 across 88 observational studies indexed under Depression, Postpartum.

Browse Depression, Postpartum studies →

Lead sponsor

Weprom is the lead sponsor of 21 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 3 Years
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Parent of a child who has already been diagnosed with a developmental disorder, known physical or mental disability
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
4,346 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • users

    users of the web-application MALO

    Device: web-application

Interventions

  • Deviceweb-application

    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.

    Also known as: MALO

06

What researchers measure

Primary outcomes

  1. impact on neurodevelopmental disorders detection

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

    Time frame: 3 years

  2. impact on hearing disorders

    description of the rate and age at detection

    Time frame: 3 years

  3. impact on visual disorders

    description of the rate and age at detection

    Time frame: 3 years

  4. impact on mandatory or recommended vaccines

    rate of vaccines

    Time frame: 3 years

  5. impact on postnatal depression

    rate of women in post natal depression

    Time frame: 3 years

07

Study locations

1 site
  • ILC
    Le Mans, 72000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05215028
Lead sponsor
Weprom
Collaborators
Kelindi
Responsible party
Sponsor
First posted
Jan 31, 2022
Start date
Nov 11, 2021
Primary completion
Jan 7, 2022
Completion
Jan 7, 2022
Last update
Jan 31, 2022

Study contacts

Fabrice DENIS, Pr
principal investigator · ILC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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