Early Detection Neurodevelopmental Disorders of Children... | NCT06301087

Studies
Early Detection Neurodevelopmental Disorders of Children and Prevention of Postnatal Depression by Mobile Health App

NCT06301087

Sponsor

Weprom

Status

Completed

Last Update Posted

Mar 15, 2024Actual

Enrollment

55,618Actual

Phase

Not provided

Conditions

Development, Child
Postnatal Depression

Interventions

Web Application

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

Feb 8, 2024Actual

Completion Date

Feb 8, 2024Actual

First Submitted Date

Mar 1, 2024

First Submission Date that Met QC Criteria

Mar 1, 2024

First Posted Date

Mar 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2024

Last Update Posted Date

Mar 15, 2024Actual

Name	Class
Kelindi	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to confirm the impact of using this app adapted to be more specific for screening for 5 neurodevelopmental disorders and to evaluate the mothers' support program on the incidence of postpartum depression in of young parents with a minimum of 1 child under 10 years of age at the time of inclusion and using Malo on a regular basis. The main questions it aims to answer are :

the median age of possible neurodevelopmental disorders notification of infants
the median time of the mothers' postnatal depression notifications after childbirth subsequently to the support and prevention program Participants will agree with use of their data

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

55,618Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
users		users of the web-application	Device: Web Application

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Web Application	Device	web application for monitoring children's development and postnatal depression of mothers	users

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to neurodevelopment desorder diagnostic	Number of days between birth and notification of possible neurodevelopment desorder notification	20 months

Secondary Outcomes

Measure	Description	Time Frame
User's satisfaction	Home made qualitatif satisfaction questionnaire	20 months
Relevance of the neurodevelopmental desorder notification	Parent's feedback for physician's opinion after notification

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Youg parent with a minimum of 1 child under 10 years
User of the app (downloaded)
Having given informed consent (in-app)

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

10 Years

Standard Ages

Child

Study Population

The population will include the first 50,000 users of the application who consent to the use of their data for this assessment

young parent withe a minimum of 1 child under 10 years matching the criteria and agreeing to participate

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Fabrice DENIS	Kelindi	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38888952	Derived	Denis F, Le Goff F, Desbois M, Gepner A, Feliciano G, Silber D, Zeitoun JD, Assuied GP. Early Detection of 5 Neurodevelopmental Disorders of Children and Prevention of Postnatal Depression With a Mobile Health App: Observational Cross-Sectional Study. JMIR Public Health Surveill. 2024 Jun 18;10:e58565. doi: 10.2196/58565.

ID	Term
D019052	Depression, Postpartum
D065886	Neurodevelopmental Disorders

ID	Term
D011644	Puerperal Disorders
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases