Sudden Death in ChildrenNCT03934242
Impact of Information Campaign's Alongside Maternity Staff About Bedding Infant
An observational study of Sudden Death in Children, run by CHU de Reims at 1 site in France.
Trial summary
It is now well established that infants should be placed on the back only in a SleepSack without coverage or plush or pillow on a firm mattress in a bedroom. Despite these old recommendations of good practice, deviations are observed and some infants are most always lying according to the recommended position. Read more about this study
- Who is it for?
- Ages Up to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Sudden Death in Children
- What is being tested?
- Questionnaire on new born's bedding
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2019to 5 Jun 2019
- 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 Up to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Study population: every newborn
Who may be able to join
- born in reims CHU
- parents are 18 years old or more
- parents accept their participation in the study
Who cannot join
- hospitalization in URIP / kangourou / neonatalogy
- needed baby warmer
Trial locations and contacts
1 site in 1 country.
About this study
It is now well established that infants should be placed on the back only in a SleepSack without coverage or plush or pillow on a firm mattress in a bedroom. Despite these old recommendations of good practice, deviations are observed and some infants are most always lying according to the recommended position. The goal is to assess the impact of an information campaign of staffs maternity of the CHU of Reims on the practices of the sleeping of infants to motherhood, and then at the home of the parents.
Read the detailed description
Proposal for participation to the holders of parental authority of newborns eligible within 72 hours after the birth of the child. If acceptance of participation, the newborn will be included in the study. Participation in the study will not affect the medical care of the child. Participation in the study will consist of: a collection of data including the child sleeping mode, complete a questionnaire covering the child sleeping habits to motherhood and home during the 1st month of life. Information on the habits of sleeping in the home of the child will be collected via a phone call by an investigator. Inclusions will be held over 2 periods: one before and one after the completion of training of health care personnel regarding the sleeping of infants nursing staff training will consist of oral information by the investigative team and written information...
- Conditions
- Sudden Death in Children
- Being tested
- Questionnaire on new born's bedding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire on new born's beddingOther
Questionnaire on new born's bedding (Child's position in the bed : dorsal, ventral or lateral, presence of pillow or stuffed in bed, presence of coverage and presence of the bed sharing) at two times (during hospitalisation and one month later)
| Study group | Role | What they receive |
|---|---|---|
| New born group 1 | New born who was born at the maternity of the CHU of Reims during a period of inclusion of one month, before nurses formation on the newborn's bedding Receives: Other: Questionnaire on new born's bedding | |
| New born group 2 | New born who was born at the maternity of the CHU of Reims during a period of inclusion of one month, after nurses formation on the newborn's bedding Receives: Other: Questionnaire on new born's bedding |
What is being measured
The primary outcome is the main question the study is designed to answer.
correct new born's bedding
Newborn's bedding will be considered correct if the newborn is lying alone (no bed sharing), in exclusive dorsal position (no ventral or lateral position), in a bed without pillow, without blanket and without soft toy.
Measured: Day 0
correct new born's bedding
Newborn's bedding will be considered correct if the newborn is lying alone (no bed sharing), in exclusive dorsal position (no ventral or lateral position), in a bed without pillow, without blanket and without soft toy.
Measured: month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start5 Mar 2019
- Primary completion5 May 2019
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Death in ChildrenStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934242
- Sponsor's protocol ID
- PO19012
- Status last verified
- Apr 2019
- First submitted
- 12 Mar 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Information Campaign's Alongside Maternity Staff About Bedding Infant
- ClinicalTrials.gov ID
- NCT03934242
- Acronym / sponsor ID
- PO19012
- Conditions
- Sudden Death in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 1 May 2019 (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.
It is now well established that infants should be placed on the back only in a SleepSack without coverage or plush or pillow on a firm mattress in a bedroom. Despite these old recommendations of good practice, deviations are observed and some infants are most always lying according to the recommended position. The goal is to assess the impact of an information campaign of staffs maternity of the CHU of Reims on the practices of the sleeping of infants to motherhood, and then at the home of the parents.
Detailed description
Proposal for participation to the holders of parental authority of newborns eligible within 72 hours after the birth of the child. If acceptance of participation, the newborn will be included in the study. Participation in the study will not affect the medical care of the child. Participation in the study will consist of: a collection of data including the child sleeping mode, complete a questionnaire covering the child sleeping habits to motherhood and home during the 1st month of life. Information on the habits of sleeping in the home of the child will be collected via a phone call by an investigator. Inclusions will be held over 2 periods: one before and one after the completion of training of health care personnel regarding the sleeping of infants nursing staff training will consist of oral information by the investigative team and written information...
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New born group 1 | – | Other: Questionnaire on new born's beddingNew born who was born at the maternity of the CHU of Reims during a period of inclusion of one month, before nurses formation on the newborn's bedding |
| New born group 2 | – | Other: Questionnaire on new born's beddingNew born who was born at the maternity of the CHU of Reims during a period of inclusion of one month, after nurses formation on the newborn's bedding |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- every newborn
Key inclusion criteria (3 listed)
- born in reims CHU
- parents are 18 years old or more
- parents accept their participation in the study
Key exclusion criteria (2 listed)
- hospitalization in URIP / kangourou / neonatalogy
- needed baby warmer
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 on new born's beddingQuestionnaire on new born's bedding (Child's position in the bed : dorsal, ventral or lateral, presence of pillow or stuffed in bed, presence of coverage and presence of the bed sharing) at two times (during hospitalisation and one month later) | Other | New born group 1, New born group 2 |
Primary outcome
correct new born's bedding
Time frame: Day 0
Newborn's bedding will be considered correct if the newborn is lying alone (no bed sharing), in exclusive dorsal position (no ventral or lateral position), in a bed without pillow, without blanket and without soft toy.
correct new born's bedding
Time frame: month 1
Newborn's bedding will be considered correct if the newborn is lying alone (no bed sharing), in exclusive dorsal position (no ventral or lateral position), in a bed without pillow, without blanket and without soft toy.
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 24 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sudden Death in Children, run by CHU de Reims 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 3 inclusion and 2 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 24 Jul 2019. 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?
correct new born's bedding (time frame: Day 0). The study lists 2 primary outcomes in all. 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 24 Jul 2019.