Infant, Premature, DiseasesEvOralNCT03860142
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
An observational study of Infant, Premature, Diseases, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 36 months
- Conditions the study is for
- Infant, Premature, Diseases
- What is being tested?
- Archet scale
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 79 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2018to 30 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 36 months
- All sexes
- No healthy volunteers
- Child
Study population: term and prematurely born child
Who may be able to join
- Children whose age ≥ 24 months and ≤ 36 months
- Full-term or prematurely born (<33 SA) at Nice University Hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Archet scale
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Archet scaleBehavioural
Parents will be asked to answer questions about their child's nutrition by using a new scale : Archet scale
| Study group | Role | What they receive |
|---|---|---|
| full-term child born | use of a new scale to rate the severity of food disorders on full-term child born Receives: Behavioral: Archet scale | |
| premature child born | use of a new scale to rate the severity of food disorders on premature child born Receives: Behavioral: Archet scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 mn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start30 Nov 2018
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860142
- Sponsor's protocol ID
- 18-PP-06
- Acronym
- EvOral
- Status last verified
- Nov 2023
- First submitted
- 28 Feb 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03860142
- Acronym / sponsor ID
- EvOral / 18-PP-06
- Conditions
- Infant, Premature, Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| full-term child born | – | Behavioral: Archet scaleuse of a new scale to rate the severity of food disorders on full-term child born |
| premature child born | – | Behavioral: Archet scaleuse of a new scale to rate the severity of food disorders on premature child born |
Who may qualify
- Ages
- 24 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- term and prematurely born child
Key inclusion criteria (2 listed)
- Children whose age ≥ 24 months and ≤ 36 months
- Full-term or prematurely born (<33 SA) at Nice University Hospital
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Archet scaleParents will be asked to answer questions about their child's nutrition by using a new scale : Archet scale | Behavioural | full-term child born, premature child born |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Premature, Diseases, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Archet scale score (time frame: 15 mn). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.