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

Sudden Death in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934242
• Other study ID #: PO19012
• Status: Completed
• Start date: March 5, 2019
• Est. completion date: June 5, 2019

Study information

• Verified date: April 2019
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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...

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 5, 2019
• Est. primary completion date: May 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria:

• born in reims CHU

• parents are 18 years old or more

• parents accept their participation in the study

Exclusion criteria :

• hospitalization in URIP / kangourou / neonatalogy

• needed baby warmer

Related Conditions & MeSH terms

• Death, Sudden
• Sudden Death in Children

Intervention

Other:
• Questionnaire 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)

Locations

Country	Name	City	State
France	Chu Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0
Primary	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.	month 1