CClinicalTrials.gg
Status unknownNCT03482804PROCLIVEUpdated Mar 29, 2018

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

An observational study in Obstruction, Airway and Sudden; Death, Infant, sponsored by Hospices Civils de Lyon. Status unknown at 2 sites in France. Open to participants aged Up to 12 Months. Per ClinicalTrials.gov, last updated 2018-03-29.

Sponsored by Hospices Civils de Lyon · Observational

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
90
Ages
Up to 12 Months
Sex
All
01

Study summary

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.

02

Conditions studied

  • Obstruction, Airway
  • Sudden; Death, Infant
03

Who can participate

Ages eligible
Up to 12 Months
Sexes eligible
All
Sampling method
Probability sample

Study population

Parents of infants from 0 to 12 months attending pediatric emergencies in 2 hospitals are interroged :

  • Hôpital Femme Mere Enfant (Bron)
  • Hôpital Nord-Ouest (Villefranche sur Saône) Are included 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

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

Exclusion Criteria:

  • Refusal to participate
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Interventions

  • OtherQuestionnaires

    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.

05

What researchers measure

Primary outcomes

  1. Sliding of the infant in the bottom of his bed in inclined position during sleep

    Sliding of the infant in the bottom of his bed in inclined position during sleep, reported by the parents during the questionnaire in the form of a closed question.

    Time frame: 1 day

06

Study locations

2 sites
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03482804
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Mar 29, 2018
Start date
Apr 2018 (estimated)
Primary completion
Oct 2018 (estimated)
Completion
Oct 2018 (estimated)
Last update
Mar 29, 2018

Study contacts

Jean STAGNARA, Dr
Contact
jeanstagnara@wanadoo.fr
0472830345 ext. +33

Oversight

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

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