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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Age range

24 month–36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Nice hospital

Nice, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Archet scale

Behavioral

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: EvOral

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 1, 2019
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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