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

Post Partum Depression Clinical Trial

— MALO_2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05215028
• Other study ID #: WP-2022-02
• Status: Completed
• Start date: November 11, 2021
• Est. completion date: January 7, 2022

Study information

• Verified date: January 2022
• Source: Weprom
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4346
• Est. completion date: January 7, 2022
• Est. primary completion date: January 7, 2022
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Development Disorder
• Depression, Postpartum
• Developmental Disabilities
• Post Partum Depression

Intervention

Device:
• web-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.

Locations

Country	Name	City	State
France	ILC	Le Mans

Sponsors (2)

Lead Sponsor	Collaborator
Weprom	Kelindi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	impact on neurodevelopmental disorders detection	description of the rate and age at detection of each type of neurodevelopmental desorder	3 years
Primary	impact on hearing disorders	description of the rate and age at detection	3 years
Primary	impact on visual disorders	description of the rate and age at detection	3 years
Primary	impact on mandatory or recommended vaccines	rate of vaccines	3 years
Primary	impact on postnatal depression	rate of women in post natal depression	3 years