The Inclined Position in Case of Respiratory Discomfort in the One Year Less Infant : Study on the Profits and the Risks in the Home

NCT ID: NCT03482804

Last Updated: 2018-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-30

Study Completion Date

2018-10-31

Brief Summary

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The inclined position at 30 ° in case of transient respiratory discomfort is recommended since the consensus conference of September 2000. This recommendation is based on a low level of evidence (grade C). This advice is found in the health book, and in many tips for parents. However, it does not comply with the recommendations of the American Academy of Pediatrics for sleeping on the back, on a firm mattress and without other objects in the bed.

70% of pediatricians advise this position in a specific medical context according to a study of Bellaïche conducted in 2013. 40% of parents use it for no particular reason.

Anatomically, the upper airways of infants are of reduced caliber, and therefore at risk of obstruction.

A study by Bergougnioux on the cases of MIN in infants wearing a wrap-around sling shows that the flexion of the neck causes the chin to be positioned against the chest and contributes to the suffocation of the infant. This is especially important in infants under 3 months whose neck muscles do not yet support the weight of the head.

The 2009 InVS national survey of unexpected infant deaths shows that bed crashes accounted for 11.1% of all deaths reported. Among unexplained deaths, maladaptive bedding was a contributing factor, including the use of a pillow in the bed in 24.3% of cases.

It was observed in the study by Kornhauser Cerar et al in 2009 that half-sitting in a car seat for an extended duration was at the origin of a significant desaturations rate, which was also found in the car bed group. The control group "hospital bed" was not subject to these desaturations. These results support the fact that only an adapted bedding that complies with the recommendations protects against asphyxiation.

Since 2016, INPES recommends in its advice sheet on bronchiolitis for parents, a flat bed on the back.

Hypothesis :

The inclined position in infants under one year of age is at risk of unexpected death of the infant by obstruction of the upper airways, because of the changes of position that it entails, including a risk of slipping at the bottom of the bed and of asphyxiation under the covers.

Detailed Description

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Conditions

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Obstruction, Airway Sudden; Death, Infant

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Questionnaires

Parents will be interviewed before being seen in consultation in the emergency room. The reason for consultation will not be taken into account, the only criterion being the age of the child. There will be no sign in the waiting room, the study will be proposed to them by the principal investigator.

The questionnaires will be collected on live paper. The answers will be transferred in a second time on an Excel database protected by a password.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Infant from 0 to 12 months
* Lie in a proclive position while sleeping
* Whose parents / parent authority holders informed about the terms of the study and agree to answer the questionnaire

Exclusion Criteria

* Refusal to participate
Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Femme Mère Enfant

Bron, , France

Site Status

Accueil des urgences pédiatriques - Hôpital Nord-Ouest Villefranche sur Saône

Gleizé, , France

Site Status

Countries

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France

Central Contacts

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Jean STAGNARA, Dr

Role: CONTACT

0472830345 ext. +33

Facility Contacts

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Jean STAGNARA, Dr

Role: primary

0472830345 ext. +33

Jacques VERMONT, Dr

Role: backup

Philippe REBAUD, Dr

Role: primary

04 74 09 28 53 ext. +33

Other Identifiers

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69HCL18_0161

Identifier Type: -

Identifier Source: org_study_id

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