The Multi-disciplinary Approach of Children With Feeding Difficulties and Tube Feeding in UZB Between 2000 and 2021

• Conditions: Enteral Nutrition; Parenteral Nutrition; Tube Feeding; Oral Aversion
• Interventions: Combination Product: Structured multi-disciplinary approach

• Registration Number: NCT06161350
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-08
• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-11-29
• Last Update Submitted: 2023-11-29
• Study First Posted: 2023-12-07
• Last Update Posted: 2023-12-07
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 330

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.

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Exclusion Criteria

• Have no 6-months follow-up available.
• Parents refusal to enter a multi-disciplinary approach for the feeding problems of their children.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Structured multi-disciplinary approach	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.

Primary Outcome Measures

Name	Time	Method
Growth (weight-for-height Z-scores)	at 3, 6, 12, 18 months and 2 years

Secondary Outcome Measures

Name	Time	Method
Comparing the mean of the 2 groups of total number of days tube fed	At 3, 6, 12, 18 months and 2 years
Comparing the mean of the 2 groups of the percentage of intake through tube feeding	At 3, 6, 12, 18 months and 2 years

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Brussels Hoofdstedelijk Gewest, Belgium