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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)

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ClinicalTrials.gov Identifier: NCT03860142
Recruitment Status : Unknown
Verified February 2019 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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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.


Condition or disease Intervention/treatment
Infant, Premature, Diseases Behavioral: Archet scale

Study Design
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Study Type : Observational
Estimated Enrollment : 168 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : May 20, 2019
Estimated Study Completion Date : May 20, 2019
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   24 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
term and prematurely born child
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860142


Contacts
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Contact: Stéphanie DE SMET, PhD 4 92 03 63 65 ext +33 desmet@chu-nice.fr

Locations
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France
Nice hospital Recruiting
Nice, France, 06000
Contact: Stéphanie DE SMET, PhD    4 92 03 63 65 ext +33    desmet@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03860142    
Other Study ID Numbers: 18-PP-06
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infant, Premature, Diseases
Infant, Newborn, Diseases