- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06222060
Evaluation of Young Parents' Knowledge of Shaken Baby Syndrome in Maternity Wards
January 26, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aymeric CANTAIS, MD
- Phone Number: +33 (0)477828134
- Email: aymeric.cantais@chu-st-etienne.fr
Study Contact Backup
- Name: Floriane MANIOULOUX, resident
- Phone Number: +33 (0)477828134
- Email: aymeric.cantais@chu-st-etienne.fr
Study Locations
-
-
-
Saint-Etienne, France, 42000
- Recruiting
- CHU Saint-Etienne
-
Contact:
- Aymeric CANTAIS, MD
- Phone Number: +33 (0)477828190
- Email: aymeric.cantais@chu-st-etienne.fr
-
Sub-Investigator:
- Floriane MANIOULOUX, resident
-
Principal Investigator:
- Aymeric CANTAIS, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Parents of newborns in maternity wards
Description
Inclusion Criteria:
- Parents of newborns in maternity wards
Exclusion Criteria:
- Single parent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Parents
Couples of parents of newborns
|
Knowledge assessment questionnaire completed in the maternity ward by both parents
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shaken Baby Syndrome Knowledge
Time Frame: Week 1, 6
|
Change in the proportion of correct knowledge about Shaken Baby Syndrome : a higher level of knowledge indicates a better result.
|
Week 1, 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Aymeric CANTAIS, MD, CHU Saint-Etienne
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 2, 2023
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
April 1, 2024
Study Registration Dates
First Submitted
January 15, 2024
First Submitted That Met QC Criteria
January 15, 2024
First Posted (Actual)
January 24, 2024
Study Record Updates
Last Update Posted (Actual)
January 29, 2024
Last Update Submitted That Met QC Criteria
January 26, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRBN462023/CHUSTE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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