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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Enteral Nutrition; Parenteral Nutrition; Tube Feeding; Oral Aversion
• Intervention / Treatment: Combination product: Structured multi-disciplinary approach

• Study Type: Observational
• Enrollment (Estimated): 330

Contacts and Locations

Study Locations

• Belgium
  • Brussels Hoofdstedelijk Gewest
    • Jette, Brussels Hoofdstedelijk Gewest, Belgium, 1090
      • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Combination product: Structured multi-disciplinary approach; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Elisabeth De Greef, MD, PhD, Universitair Ziekenhuis Brussel; Principal Investigator: Koen Huysentruyt, MD, PhD, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Estimated): December 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ORALAV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No