Enteral Nutrition Clinical Trial
— ORALAVOfficial title:
The Multi-disciplinary Approach of Children With Feeding Difficulties and Tube Feeding in UZB Between 2000 and 2021: a Retrospective Cohort Study
Verified date | November 2023 |
Source | Universitair Ziekenhuis Brussel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 330 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 12 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Have no 6-months follow-up available. - Parents refusal to enter a multi-disciplinary approach for the feeding problems of their children. |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis Brussel | Jette | Brussels Hoofdstedelijk Gewest |
Lead Sponsor | Collaborator |
---|---|
Universitair Ziekenhuis Brussel |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Compare how many infants completed full oral intake after two years before and after the implementation of the pre-convention for feeding difficulties. | 2 years | ||
Other | Compare the percentage of tube feeding that remains in the group that was unable to achieve full oral intake after one year, before and after the implementation of the pre-convention for feeding difficulties. | 1 year | ||
Primary | Growth (weight-for-height Z-scores) | at 3, 6, 12, 18 months and 2 years | ||
Secondary | Comparing the mean of the 2 groups of total number of days tube fed | At 3, 6, 12, 18 months and 2 years | ||
Secondary | Comparing the mean of the 2 groups of the percentage of intake through tube feeding | At 3, 6, 12, 18 months and 2 years |
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