- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03482804
The Inclined Position in Case of Respiratory Discomfort in the One Year Less Infant : Study on the Profits and the Risks in the Home (PROCLIVE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jean STAGNARA, Dr
- Phone Number: +33 0472830345
- Email: jeanstagnara@wanadoo.fr
Study Locations
-
-
-
Bron, France, 69677
- Hôpital Femme Mère Enfant
-
Contact:
- Jean STAGNARA, Dr
- Phone Number: +33 0472830345
- Email: jeanstagnara@wanadoo.fr
-
Contact:
- Jacques VERMONT, Dr
- Email: jacques.vemont@chu-lyon.fr
-
Gleizé, France, 69400
- Accueil des urgences pédiatriques - Hôpital Nord-Ouest Villefranche sur Saône
-
Contact:
- Philippe REBAUD, Dr
- Phone Number: +33 04 74 09 28 53
- Email: prebaud@lhopitalnordouest.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sliding of the infant in the bottom of his bed in inclined position during sleep
Time Frame: 1 day
|
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.
|
1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL18_0161
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstruction, Airway
-
Beth Israel Deaconess Medical CenterMedWaves, IncRecruitingAirway Obstruction | Central Airway ObstructionUnited States
-
McMurray Medical Group, LLCCompletedUpper Airway ObstructionUnited States
-
Massachusetts General HospitalCompletedUpper Airway ObstructionUnited States
-
Rigshospitalet, DenmarkCompletedUpper Airway ObstructionDenmark
-
Zhongda HospitalUnknownMalignant Airway ObstructionChina
-
Assistance Publique - Hôpitaux de ParisRecruitingRespiratory Distress | Upper Airway ObstructionFrance
-
ResMedCompletedRespiratory Failure | Respiratory Insufficiency | Upper Airway ObstructionUnited States
-
Massachusetts General HospitalCompletedMechanical Ventilation Complication | Upper Airway ObstructionUnited States
-
Aerin MedicalOhio State UniversityCompletedNasal ObstructionUnited States
-
University of RochesterCompletedUpper Airway ObstructionUnited States
Clinical Trials on Questionnaires
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Direction Centrale du Service de Santé des ArméesCompleted
-
Sun Yat-sen UniversityNot yet recruiting
-
Assistance Publique - Hôpitaux de ParisRecruitingIntensive Care Unit Syndrome | Pediatric Post-intensive Care SyndromeFrance
-
University Hospital, GrenobleUniversity Grenoble AlpsNot yet recruitingChildhood Cancer | Adapted Physical ActivityFrance
-
M.D. Anderson Cancer CenterCompletedAdvanced Cancer | Malignant Neoplasms of Independent (Primary) Multiple SitesUnited States
-
The University of Hong KongCompleted
-
Centre Hospitalier Universitaire DijonCompleted
-
Cliniques universitaires Saint-Luc- Université...Fonds National de la Recherche ScientifiqueNot yet recruitingAlcohol Use Disorder
-
Memorial Sloan Kettering Cancer CenterIcahn School of Medicine at Mount Sinai; Hackensack Meridian Health; Derald H...CompletedLeukemia | Multiple Myeloma | Non-Hodgkin's Lymphoma | Hodgkin's DiseaseUnited States