Oral AversionORALAVNCT06161350
The Multi-disciplinary Approach of Children With Feeding Difficulties and Tube Feeding in UZB Between 2000 and 2021
An observational study of Oral Aversion and Enteral Nutrition, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The goal of this Retrospective Cohort Study is to compare the patients from before and after the implementation of the pre-convention for infants with feeding difficulties needing tube feeding or having received tube feeding in the past, but able to develop normal feeding behavior. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Oral Aversion, Enteral Nutrition, Parenteral Nutrition
- What is being tested?
- Structured multi-disciplinary approach
- Type of treatment
- Pill or oral medicine
- How many people
- 330 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Nov 2023to 30 Sep 2024
- 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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Infants with feeding difficulties needing tube feeding or having received tube feeding in the past, capable of developing normal feeding behavior.
Who may be able to join
- Children consulting a pediatric gastroenterologist for feeding problems in UZB between the 1st of January 2000 and the 31st of December 2021 and receiving the label "feeding difficulties".
- The infants have a pediatric feeding disorder that prevent them from feeding normally by oral means.
- The infants need or have needed (enteral or parenteral) artificial nutrition.
- The infants are aged between 0 and 12 years at their first presentation.
- The infants are capable of developing normal feeding behavior.
Who cannot join
- Have no 6-months follow-up available.
- Parents refusal to enter a multi-disciplinary approach for the feeding problems of their children.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Multi-disciplinary Approach of Children With Feeding Difficulties and Tube Feeding in UZB Between 2000 and 2021: a Retrospective Cohort Study
The goal of this Retrospective Cohort Study is to compare the patients from before and after the implementation of the pre-convention for infants with feeding difficulties needing tube feeding or having received tube feeding in the past, but able to develop normal feeding behavior.
The main objectives it aims to compare are:
- To characterize the patients taking part in a multi-disciplinary follow-up for feeding difficulties over time and to evaluate their progress before and after the institution of a multidisciplinary team in the context of the pre-convention for feeding difficulties from the RIZIV/INAMI.
- To evaluate if the multi-disciplinary approach is more efficient for treatment and follow-up in infants with eating difficulties before and after the start of the pre-convention.
- To calculate the probability of reaching full oral intake after having feeding difficulties within two years.
- Conditions
- Oral Aversion, Enteral Nutrition, Parenteral Nutrition, Tube Feeding
- Being tested
- Structured multi-disciplinary approach
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured multi-disciplinary approachCombination product
Since 2010, a structured multidisciplinary team was formed to evaluate the child medically, support its nutrition, teach, treat and educate the children and parents and guide them through the process to obtain a normal and independent feeding behavior. The multidisciplinary team must have special expertise regarding digestive and nutritional as well as sensory and oral motor problems in children requiring artificial nutrition. The team must at least consist of a pediatrician, a dietician with experience in artificial nutrition in children, a speech therapist and/or physical therapist and a psychologist or orthopedagogue. The team should also be able to rely on a nurse with experience in artificial nutrition, a social assistant and a secretary.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Infants who consulted between January 1st 2000 and December 31st 2009 (this is before the implementation of the pre-convention). Inclusion criteria: * Children consulting a pediatric gastroenterologist for feeding problems in UZB between the 1st of January 2000 and the 31st of December 2009 and receiving the label "feeding difficulties". * The infants have a pediatric feeding disorder that prevent them from feeding normally by oral means. * The infants need or have needed (enteral or parenteral) artificial nutrition. * The infants are aged between 0 and 12 years at their first presentation. * The infants are capable of developing normal feeding behavior. Infants will be excluded from this study if they: * Have no 6-months follow-up available. * Parents refusal to enter a multi-disciplinary approach for the feeding problems of their children. | |
| Group 2 | Infants who consulted after the implementation of the pre-convention, who consulted between January 1st 2010 and December 31st 2021.
Inclusion criteria:
* Children consulting a pediatric gastroenterologist for feeding problems in UZB between the 1st of January 2010 and the 31st of December 2021 and receiving the label "feeding difficulties".
* The infants have a pediatric feeding disorder that prevent them from feeding normally by oral means.
* The infants need or have needed (enteral or parenteral) artificial nutrition.
* The infants are aged between 0 and 12 years at their first presentation.
* The infants are capable of developing normal feeding behavior.
Infants will be excluded from this study if they:
* Have no 6-months follow-up available.
* Parents refusal to enter a multi-disciplinary approach for the feeding problems of their children. Receives: Combination Product: Structured multi-disciplinary approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth (weight-for-height Z-scores)
Measured: at 3, 6, 12, 18 months and 2 years
Secondary outcomes (2)
Comparing the mean of the 2 groups of total number of days tube fed
Measured: At 3, 6, 12, 18 months and 2 years
Comparing the mean of the 2 groups of the percentage of intake through tube feeding
Measured: At 3, 6, 12, 18 months and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start8 Nov 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral AversionStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Retrospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabeth De Greef, Universitair Ziekenhuis Brussel
- Investigators
- Elisabeth De Greef, MD, PhD, Principal investigator, Universitair Ziekenhuis BrusselKoen Huysentruyt, MD, PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161350
- Sponsor's protocol ID
- ORALAV
- Acronym
- ORALAV
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2023
- Last updated
- 7 Dec 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 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multi-disciplinary Approach of Children With Feeding Difficulties and Tube Feeding in UZB Between 2000 and 2021: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06161350
- Acronym / sponsor ID
- ORALAV / ORALAV
- Conditions
- Oral Aversion, Enteral Nutrition, Parenteral Nutrition, Tube Feeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 7 Dec 2023 (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.
The goal of this Retrospective Cohort Study is to compare the patients from before and after the implementation of the pre-convention for infants with feeding difficulties needing tube feeding or having received tube feeding in the past, but able to develop normal feeding behavior.
The main objectives it aims to compare are:
- To characterize the patients taking part in a multi-disciplinary follow-up for feeding difficulties over time and to evaluate their progress before and after the institution of a multidisciplinary team in the context of the pre-convention for feeding difficulties from the RIZIV/INAMI.
- To evaluate if the multi-disciplinary approach is more efficient for treatment and follow-up in infants with eating difficulties before and after the start of the pre-convention.
- To calculate the probability of reaching full oral intake after having feeding difficulties within two years.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Infants who consulted between January 1st 2000 and December 31st 2009 (this is before the implementation of the pre-convention). Inclusion criteria: * Children consulting a pediatric gastroenterologist for feeding problems in UZB between the 1st of January 2000 and the 31st of December 2009 and receiving the label "feeding difficulties". * The infants have a pediatric feeding disorder that prevent them from feeding normally by oral means. * The infants need or have needed (enteral or parenteral) artificial nutrition. * The infants are aged between 0 and 12 years at their first presentation. * The infants are capable of developing normal feeding behavior. Infants will be excluded from this study if they: * Have no 6-months follow-up available. * Parents refusal to enter a multi-disciplinary approach for the feeding problems of their children. |
| Group 2 | – | Combination Product: Structured multi-disciplinary approachInfants who consulted after the implementation of the pre-convention, who consulted between January 1st 2010 and December 31st 2021. Inclusion criteria: * Children consulting a pediatric gastroenterologist for feeding problems in UZB between the 1st of January 2010 and the 31st of December 2021 and receiving the label "feeding difficulties". * The infants have a pediatric feeding disorder that prevent them from feeding normally by oral means. * The infants need or have needed (enteral or parenteral) artificial nutrition. * The infants are aged between 0 and 12 years at their first presentation. * The infants are capable of developing normal feeding behavior. Infants will be excluded from this study if they: * Have no 6-months follow-up available. * Parents refusal to enter a multi-disciplinary approach for the feeding problems of their children. |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants with feeding difficulties needing tube feeding or having received tube feeding in the past, capable of developing normal feeding behavior.
Key inclusion criteria (5 listed)
- Children consulting a pediatric gastroenterologist for feeding problems in UZB between the 1st of January 2000 and the 31st of December 2021 and receiving the label "feeding difficulties".
- The infants have a pediatric feeding disorder that prevent them from feeding normally by oral means.
- The infants need or have needed (enteral or parenteral) artificial nutrition.
- The infants are aged between 0 and 12 years at their first presentation.
- The infants are capable of developing normal feeding behavior.
Key exclusion criteria (2 listed)
- Have no 6-months follow-up available.
- Parents refusal to enter a multi-disciplinary approach for the feeding problems of their children.
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 |
|---|---|---|
| Structured multi-disciplinary approachSince 2010, a structured multidisciplinary team was formed to evaluate the child medically, support its nutrition, teach, treat and educate the children and parents and guide them through the process to obtain a normal and independent feeding behavior. The multidisciplinary team must have special expertise regarding digestive and nutritional as well as sensory and oral motor problems in children requiring artificial nutrition. The team must at least consist of a pediatrician, a dietician with experience in artificial nutrition in children, a speech therapist and/or physical therapist and a psychologist or orthopedagogue. The team should also be able to rely on a nurse with experience in artificial nutrition, a social assistant and a secretary. | Combination product | Group 2 |
Primary outcome
Growth (weight-for-height Z-scores)
Time frame: at 3, 6, 12, 18 months and 2 years
2 secondary outcomes
Comparing the mean of the 2 groups of total number of days tube fed
Time frame: At 3, 6, 12, 18 months and 2 years
Comparing the mean of the 2 groups of the percentage of intake through tube feeding
Time frame: At 3, 6, 12, 18 months and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: Undecided
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.
Elisabeth De Greef, MD, PhD principal investigator
Universitair Ziekenhuis Brussel
Koen Huysentruyt, MD, PhD principal investigator
Universitair Ziekenhuis Brussel
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 Oral Aversion and Enteral Nutrition, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Dec 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 Belgium. 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?
Results are not available in the source record.
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?
Growth (weight-for-height Z-scores) (time frame: at 3, 6, 12, 18 months and 2 years). 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 7 Dec 2023.