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

Enteral Nutrition Clinical Trial

— ORALAV  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06161350
• Other study ID #: ORALAV
• Status: Enrolling by invitation
• Start date: November 8, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Enteral Nutrition
• Oral Aversion
• Parenteral Nutrition
• Tube Feeding

Intervention

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.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussels Hoofdstedelijk Gewest

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

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