Shaken Baby SyndromeNCT06222060
Evaluation of Young Parents' Knowledge of Shaken Baby Syndrome in Maternity Wards
An observational study of Shaken Baby Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shaken Baby Syndrome
- What is being tested?
- Questionnaire about Shaken Baby Syndrome
- How many people
- 686 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2023to 3 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parents of newborns in maternity wards
Who may be able to join
- Parents of newborns in maternity wards
Who cannot join
- Single parent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Shaken Baby Syndrome
- Being tested
- Questionnaire about Shaken Baby Syndrome
- Keywords
- Shaken Baby Syndrome, Child abuse, Parental knowledge
- Medical subject headings
- Shaken Baby Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire about Shaken Baby SyndromeOther
Knowledge assessment questionnaire completed in the maternity ward by both parents
| Study group | Role | What they receive |
|---|---|---|
| Parents | Couples of parents of newborns Receives: Other: Questionnaire about Shaken Baby Syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shaken Baby Syndrome Knowledge
Change in the proportion of correct knowledge about Shaken Baby Syndrome : a higher level of knowledge indicates a better result.
Measured: Week 1, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start2 May 2023
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shaken Baby SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 686 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aymeric CANTAIS, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222060
- Sponsor's protocol ID
- IRBN462023/CHUSTE
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Young Parents' Knowledge of Shaken Baby Syndrome in Maternity Wards
- ClinicalTrials.gov ID
- NCT06222060
- Acronym / sponsor ID
- IRBN462023/CHUSTE
- Conditions
- Shaken Baby Syndrome
- Keywords
- Shaken Baby Syndrome, Child abuse, Parental knowledge
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 686 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents | – | Other: Questionnaire about Shaken Baby SyndromeCouples of parents of newborns |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parents of newborns in maternity wards
Key inclusion criteria (1 listed)
- Parents of newborns in maternity wards
Key exclusion criteria (1 listed)
- Single parent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire about Shaken Baby SyndromeKnowledge assessment questionnaire completed in the maternity ward by both parents | Other | Parents |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Shaken Baby Syndrome
Not yet recruiting
The Impact of the Nurse-Led "My Baby is Safe" Educational Program
Sudden Infant Death Syndrome, Shaken Baby Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aymeric CANTAIS, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shaken Baby Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shaken Baby Syndrome Knowledge (time frame: Week 1, 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.