- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03860142
Evolution of Food Orality in Children Aged Between 24 and 36 Months: Comparison of the Severity and Specificities of Disorders Between Two Populations of Children, Born Very Prematurely and Born at Term (EvOral)
Oral disorders are currently widely described in the premature birth population, but few studies compare them to their prevalence in the full-term population.
In addition, new behaviours and eating habits are regularly emerging in our society.
The objective of this study is to compare the severity of signs of oral disorders between the group of preterm infants and the group of term infants born without organic pathologies that compromise oral development.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Stéphanie DE SMET, PhD
- Phone Number: +33 4 92 03 63 65
- Email: desmet@chu-nice.fr
Study Locations
-
-
-
Nice, France, 06000
- Nice hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children whose age ≥ 24 months and ≤ 36 months
- Full-term or prematurely born (<33 SA) at Nice University Hospital
Exclusion Criteria:
- Children with congenital pathologies (with malformations in the oro-facial sphere)
- Children with neurological and developmental pathologies unrelated to prematurity
- Children with ENT deformities
- Parental langage barrier
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
full-term child born
use of a new scale to rate the severity of food disorders on full-term child born
|
Parents will be asked to answer questions about their child's nutrition by using a new scale : Archet scale
|
premature child born
use of a new scale to rate the severity of food disorders on premature child born
|
Parents will be asked to answer questions about their child's nutrition by using a new scale : Archet scale
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Archet scale score
Time Frame: 15 mn
|
The severity of the signs of food orality disorders is assessed by Archet Scale, which makes it possible to establish a score out of 20.
The severity of the signs is divided into four classes according to the following scores: from 0 to 5 = zero to low grade, from 6 to 10 = light grade, from 11 to 15 = moderate grade, from 16 to 20 = severe grade
|
15 mn
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-PP-06
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.
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