Evaluation of Young Parents' Knowledge of Shaken Baby Syn... | NCT06222060

Studies
Evaluation of Young Parents' Knowledge of Shaken Baby Syndrome in Maternity Wards

NCT06222060

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Last Update Posted

Oct 18, 2024Actual

Enrollment

686Actual

Phase

Not provided

Conditions

Shaken Baby Syndrome

Interventions

Questionnaire about Shaken Baby Syndrome

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

Jan 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 2, 2023Actual

Primary Completion Date

Jun 3, 2024Actual

Completion Date

Jun 3, 2024Actual

First Submitted Date

Jan 15, 2024

First Submission Date that Met QC Criteria

Jan 15, 2024

First Posted Date

Jan 24, 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

Oct 17, 2024

Last Update Posted Date

Oct 18, 2024Actual

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

As part of everyday clinical practice, messages about preventing Shaken Baby Syndrome are delivered to young parents in maternity wards. The modality of these messages changes regularly. For example, in the near future, the messages will be delivered by video in addition to the usual practice. The investigators are setting up a prospective observational cohort study in order to evaluate and then monitor the state of knowledge of young parents on shaken baby syndrome.

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

686Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Parents		Couples of parents of newborns	Other: Questionnaire about Shaken Baby Syndrome

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire about Shaken Baby Syndrome	Other	Knowledge assessment questionnaire completed in the maternity ward by both parents	Parents

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Shaken Baby Syndrome Knowledge	Change in the proportion of correct knowledge about Shaken Baby Syndrome : a higher level of knowledge indicates a better result.	Week 1, 6

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Parents of newborns in maternity wards

Exclusion Criteria:

Single parent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Parents of newborns in maternity wards

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aymeric CANTAIS, MD	Centre Hospitalier Universitaire de Saint Etienne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Saint-Etienne		Saint-Etienne		42000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D038642	Shaken Baby Syndrome

Ancestor Terms

ID	Term
D001930	Brain Injuries
D006259	Craniocerebral Trauma
D020196	Trauma, Nervous System
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided