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
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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.
147 studies on the registry are indexed under Airway Obstruction; 25 are open to participants now.
This study's planned enrollment of 90 is below the median of 125 across 52 observational studies indexed under Airway Obstruction.
Browse Airway Obstruction studies →Hospices Civils de Lyon is the lead sponsor of 1,867 studies on the registry; 448 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Parents of infants from 0 to 12 months attending pediatric emergencies in 2 hospitals are interroged :
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.
Exclusion Criteria:
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.
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2018; primary completion for Oct 2018, 6 months later.
Of 28 observational studies under Airway Obstruction, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 28. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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