Infant DevelopmentOPENINGNCT05157633
Oral Exploration of Objects and Food Diversification
An observational study of Infant Development, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
Eating difficulties in infants and young children are defined as all the difficulties in feeding oneself in an appropriate and satisfactory manner. These disorders affect approximately 20 to 25% of infants and young children, and thus constitute one of the most frequent reasons for consultation in these age groups. Read more about this study
- Who is it for?
- Ages 9 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- How many people
- 354 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2021to 20 Apr 2022
- 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 9 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children with eating difficulties and children from nurseries without eating difficulties (controls).
Who may be able to join
- For patients: Children aged between 9 months and 6 years with eating difficulties defined by the Montreal HME score> = 61.
- For controls: children aged between 9 months and 6 years attending a crèche who agreed to participate in the study.
- Not opposing participation in the study.
Who cannot join
- an eating disorder defined by an MCH score> = 61 (score defined for the inclusion criteria)
- encephalopathy, neuro-metabolic disorder, genetic syndrome (after response to the questionnaire)
- For patients and controls:
- Encephalopathies
- Neuro-metabolic disorders
- Suspected or identified genetic syndromes
Trial locations and contacts
1 site in 1 country.
About this study
Eating difficulties in infants and young children are defined as all the difficulties in feeding oneself in an appropriate and satisfactory manner. These disorders affect approximately 20 to 25% of infants and young children, and thus constitute one of the most frequent reasons for consultation in these age groups. Many of these children continue to be received in consultation.
Studies show that the lack of intraoral exploration in children could be associated with later difficulties in accepting different textures or new foods. Our clinical examination of sensorimotor functions shows signs of sensory hyper reactivity that are very common in children who always wipe their hands when in contact with food or sticky objects and for those who experience difficulty in brushing or grooming themselves.
Read more
In all of the publications available which includes pubmed, there is no mention of the lack of exploration of objects and the stigma of sensory hyper-responsiveness even if this latter was not entirely detailed in the descriptions made.
The trial hypothesis is that this exploration defect corresponds to early sensory hyperreactivity which also plays a deleterious role in the acceptance of new textures and new foods.
In this trial we propose a comparison study with a controlled population of children without eating difficulties as defined by the Montreal MCH score to validate a statistical link between the difficulties in food diversification beyond 18 months and the lack of exploration of the environment with 'mouthing' between 6 and 10 months.
Investigators will analyse consultation questionnaires dedicated to eating difficulties retrospectively (patients) and will compare them with questionnaires of children from daycares without eating difficulties (controls).
Read the detailed description
To conduct this study the controls will be recruited from daycares and different nursery schools after agreement with the heads of establishments.
Two questionnaires along with an information note will be distributed to the parents and will be completed in a non-identifying manner, retrieved by the teachers and then sent to the principal investigator.
The questionnaires include the validated Montreal HME questionnaire which will detect the possible existence of eating difficulties and a more general questionnaire on the psychomotor development of the child (not validated because a qualitative questionnaire without a score). The collection of data will be prospective for controls.
Patients on the other hand will be recruited retrospectively from the dedicated oral consultation at the Hospital.
- Conditions
- Infant Development
- Being tested
- Controls
- Keywords
- Infants and children with eating difficulties
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlsOther
questionnaire food scale: HME data collection of food survey
| Study group | Role | What they receive |
|---|---|---|
| Controls | Children without eating difficulties Receives: Other: Controls | |
| Patients | Children with eating difficulties |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a delay or lack of acquisition of oral exploration of objects.
Deferred presence or absence of the acquisition of the competence of oral exploration of objects between 6 and 10 months by a qualitative questionnaire without score not validated
Measured: 1 day
Secondary outcomes (9)
To determine if there is a link between the inability to orally explore objects and difficulties in seeing and/or touching and/or smelling certain types of food
Number of children with difficulty seeing and / or touching and / or smelling certain types of food and an inability to explore objects orally.
Measured: 1 day
To determine if there is a link between the inability to orally explore objects and difficulties in seeing and/or touching and/or smelling certain types of food
Percentage of children with difficulty seeing and / or touching and / or smelling certain types of food and an inability to explore objects orally.
Measured: 1 day
To determine if there is a link between the inability to orally explore objects and the inability to touch certain non-food textures
Number of children with an inability to touch certain non-food textures and an inability to orally explore objects by a qualitative questionnaire without score not validated
Measured: 1 day
To determine if there is a link between a link between the inability to orally explore objects. And the inability to touch certain non-food textures
percentage of children with an inability to touch certain non-food textures and an inability to orally explore objects
Measured: 1 day
To determine if there is a link between a link between the inability to orally explore objects and the absence of crawling in motor development.
Number and percentage of children who have crawled in their psychomotor development
Measured: 1 day
To determine if there is a link between a link between the inability to orally explore objects and the absence of crawling in motor development.
Number of children who orally explored the objects
Measured: 1 day
To determine if there is a link between a link between the inability to orally explore objects and the absence of crawling in motor development.
percentage of children who orally explored the objects
Measured: 1 day
To determine if there is a link between an incidence of constipation in both groups of children
Number of children with constipation according to ROME IV criteria
Measured: 1 day
To determine if there is a link between an incidence of constipation in both groups of children
percentage of children with constipation according to ROME IV criteria
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start15 Sep 2021
- Primary completion20 Apr 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157633
- Sponsor's protocol ID
- OPENING
- Acronym
- OPENING
- Status last verified
- Jun 2022
- First submitted
- 8 Sep 2021
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Exploration of Objects and Food Diversification
- ClinicalTrials.gov ID
- NCT05157633
- Acronym / sponsor ID
- OPENING / OPENING
- Conditions
- Infant Development
- Keywords
- Infants and children with eating difficulties
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 15 Dec 2021 (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.
Eating difficulties in infants and young children are defined as all the difficulties in feeding oneself in an appropriate and satisfactory manner. These disorders affect approximately 20 to 25% of infants and young children, and thus constitute one of the most frequent reasons for consultation in these age groups. Many of these children continue to be received in consultation.
Studies show that the lack of intraoral exploration in children could be associated with later difficulties in accepting different textures or new foods. Our clinical examination of sensorimotor functions shows signs of sensory hyper reactivity that are very common in children who always wipe their hands when in contact with food or sticky objects and for those who experience difficulty in brushing or grooming themselves.
In all of the publications available which includes pubmed, there is no mention of the lack of exploration of objects and the stigma of sensory hyper-responsiveness even if this latter was not entirely detailed in the descriptions made.
The trial hypothesis is that this exploration defect corresponds to early sensory hyperreactivity which also plays a deleterious role in the acceptance of new textures and new foods.
In this trial we propose a comparison study with a controlled population of children without eating difficulties as defined by the Montreal MCH score to validate a statistical link between the difficulties in food diversification beyond 18 months and the lack of exploration of the environment with 'mouthing' between 6 and 10 months.
Investigators will analyse consultation questionnaires dedicated to eating difficulties retrospectively (patients) and will compare them with questionnaires of children from daycares without eating difficulties (controls).
Detailed description
To conduct this study the controls will be recruited from daycares and different nursery schools after agreement with the heads of establishments.
Two questionnaires along with an information note will be distributed to the parents and will be completed in a non-identifying manner, retrieved by the teachers and then sent to the principal investigator.
The questionnaires include the validated Montreal HME questionnaire which will detect the possible existence of eating difficulties and a more general questionnaire on the psychomotor development of the child (not validated because a qualitative questionnaire without a score). The collection of data will be prospective for controls.
Patients on the other hand will be recruited retrospectively from the dedicated oral consultation at the Hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | – | Other: ControlsChildren without eating difficulties |
| Patients | – | –Children with eating difficulties |
Who may qualify
- Ages
- 9 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children with eating difficulties and children from nurseries without eating difficulties (controls).
Key inclusion criteria (3 listed)
- For patients: Children aged between 9 months and 6 years with eating difficulties defined by the Montreal HME score> = 61.
- For controls: children aged between 9 months and 6 years attending a crèche who agreed to participate in the study.
- Not opposing participation in the study.
Key exclusion criteria (6 listed)
- an eating disorder defined by an MCH score> = 61 (score defined for the inclusion criteria)
- encephalopathy, neuro-metabolic disorder, genetic syndrome (after response to the questionnaire)
- Encephalopathies
- Neuro-metabolic disorders
- Suspected or identified genetic syndromes
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 |
|---|---|---|
| Controlsquestionnaire food scale: HME data collection of food survey | Other | Controls |
Primary outcome
Number of participants with a delay or lack of acquisition of oral exploration of objects.
Time frame: 1 day
Deferred presence or absence of the acquisition of the competence of oral exploration of objects between 6 and 10 months by a qualitative questionnaire without score not validated
9 secondary outcomes
To determine if there is a link between the inability to orally explore objects and difficulties in seeing and/or touching and/or smelling certain types of food
Time frame: 1 day
To determine if there is a link between the inability to orally explore objects and difficulties in seeing and/or touching and/or smelling certain types of food
Time frame: 1 day
To determine if there is a link between the inability to orally explore objects and the inability to touch certain non-food textures
Time frame: 1 day
To determine if there is a link between a link between the inability to orally explore objects. And the inability to touch certain non-food textures
Time frame: 1 day
To determine if there is a link between a link between the inability to orally explore objects and the absence of crawling in motor development.
Time frame: 1 day
To determine if there is a link between a link between the inability to orally explore objects and the absence of crawling in motor development.
Time frame: 1 day
To determine if there is a link between a link between the inability to orally explore objects and the absence of crawling in motor development.
Time frame: 1 day
To determine if there is a link between an incidence of constipation in both groups of children
Time frame: 1 day
To determine if there is a link between an incidence of constipation in both groups of children
Time frame: 1 day
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 23 Jun 2022.
- Individual participant dataSharing planned: No
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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 Development, run by Centre Hospitalier Intercommunal Creteil 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 3 inclusion and 6 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 23 Jun 2022. 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?
Number of participants with a delay or lack of acquisition of oral exploration of objects. (time frame: 1 day). 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 23 Jun 2022.