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: Completed
• Conditions: Infant, Premature, Diseases
• Intervention / Treatment: Behavioral: Archet scale

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • Nice Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 3 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

term and prematurely born child

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?

Number of groups / cohorts

2

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	Behavioral: Archet scale; 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	Behavioral: Archet scale; 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	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

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2018
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: February 28, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Infant, Premature, Diseases
• Other Study ID Numbers: 18-PP-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No