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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06161350
Other study ID # ORALAV
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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