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

Infant, Premature, Diseases Clinical Trial

— EvOral  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860142
• Other study ID #: 18-PP-06
• Status: Completed
• Start date: November 30, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Infant, Premature, Diseases

Intervention

Behavioral:
• Archet scale
Parents will be asked to answer questions about their child's nutrition by using a new scale : Archet scale

Locations

Country	Name	City	State
France	Nice hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Archet scale score	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