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CompletedNCT03934242Updated Jul 24, 2019

Impact of Information Campaign's Alongside Maternity Staff About Bedding Infant

An observational study in Sudden Death in Children, sponsored by CHU de Reims. Completed at 1 site in France. Open to participants aged Up to 1 Month, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-24.

Sponsored by CHU de Reims · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
Up to 1 Month
Sex
All
01

Study 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. 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...

02

Conditions studied

  • Sudden Death in Children

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03

In context

Death, Sudden

66 studies on the registry are indexed under Death, Sudden; 5 are open to participants now.

This study's enrollment of 300 is above the median of 262 across 36 observational studies indexed under Death, Sudden.

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Lead sponsor

CHU de Reims is the lead sponsor of 276 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 1 Month
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

every newborn

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • born in reims CHU
  • parents are 18 years old or more
  • parents accept their participation in the study

Exclusion criteria

Exclusion criteria :

  • hospitalization in URIP / kangourou / neonatalogy
  • needed baby warmer
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

    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

    Other: Questionnaire on new born's bedding

Interventions

  • OtherQuestionnaire on new born's bedding

    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)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 0

  2. 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.

    Time frame: month 1

07

Study locations

1 site
  • Chu Reims
    Reims, 51092, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03934242
Lead sponsor
CHU de Reims
Responsible party
Sponsor
First posted
May 1, 2019
Start date
Mar 5, 2019
Primary completion
May 5, 2019
Completion
Jun 5, 2019
Last update
Jul 24, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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