Clinical trial NCT06161350: The Multi-disciplinary Approach of Children With Feeding Difficulties and Tube Feeding in UZB Between 2000 and 2021
Official title: The Multi-disciplinary Approach of Children With Feeding Difficulties and Tube Feeding in UZB Between 2000 and 2021: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Oral Aversion
Enteral Nutrition
Parenteral Nutrition
Tube Feeding
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 330
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants with feeding difficulties needing tube feeding or having received tube feeding in the past, capable of developing normal feeding behavior.

Brief 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Growth (weight-for-height Z-scores)
timeFrame: at 3, 6, 12, 18 months and 2 years
Secondary outcomes:
measure: Comparing the mean of the 2 groups of total number of days tube fed
timeFrame: At 3, 6, 12, 18 months and 2 years
measure: Comparing the mean of the 2 groups of the percentage of intake through tube feeding
timeFrame: At 3, 6, 12, 18 months and 2 years
Other outcomes:
measure: Compare how many infants completed full oral intake after two years before and after the implementation of the pre-convention for feeding difficulties.
timeFrame: 2 years
measure: 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.
timeFrame: 1 year
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussels Hoofdstedelijk Gewest
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Elisabeth De Greef, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Koen Huysentruyt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: