Clinical trial

The Multi-disciplinary Approach of Children With Feeding Difficulties and Tube Feeding in UZB Between 2000 and 2021: a Retrospective Cohort Study

Name

ORALAV

Description

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.

Trial arms

Trial start

2023-11-08

Estimated PCD

2024-09-30

Trial end

2024-09-30

Treatment

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.

Arms:

Group 2

Size

330

Primary endpoint

Growth (weight-for-height Z-scores)

at 3, 6, 12, 18 months and 2 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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 330, 'type': 'ESTIMATED'}}

Updated at

2023-12-07

1 organization

1 product

4 indications

Organization

Universitair Ziekenhuis Brussel

Product

Structured multi-disciplinary approach

Indication

Indication

Indication

Indication