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

NCT03860142 | Completed

• 1 other identifier: 18-PP-06
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infant, Premature, Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

full-term child born

use of a new scale to rate the severity of food disorders on full-term child born

Behavioral: Archet scale

premature child born

use of a new scale to rate the severity of food disorders on premature child born

Behavioral: Archet scale

Interventions

Archet scale BEHAVIORAL

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

full-term child born; premature child born

Eligibility Criteria

• Age: 24 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

term and prematurely born child

You may qualify if:

• Children whose age ≥ 24 months and ≤ 36 months
• Full-term or prematurely born (\<33 SA) at Nice University Hospital

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Nice hospital

Nice, 06000, France

Location

MeSH Terms

Conditions

Infant, Premature, Diseases

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 1, 2019
• Study Start: November 30, 2018
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

FR (1)