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

Completed

• Conditions: Infant, Premature, Diseases
• Interventions: Behavioral: Archet scale

• Registration Number: NCT03860142
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-11-30
• Study First Submitted: 2019-02-28
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-01
• Primary Completion: 2019-05-30
• Study Completion: 2019-05-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
premature child born	Archet scale	use of a new scale to rate the severity of food disorders on premature child born
full-term child born	Archet scale	use of a new scale to rate the severity of food disorders on full-term child born

Primary Outcome Measures

Name	Time	Method
Archet scale score	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

Trial Locations

Locations (1)

Nice hospital; 🇫🇷 Nice, France