Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03705689
Other study ID # 2018-365
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date November 1, 2019

Study information

Verified date November 2020
Source Universitair Ziekenhuis Brussel
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

validation of stool scale in toddlers


Description:

objective : the Bristol stool form scale (BSFS) is inadequate for non-toilet trained children. The Brussels Infant and Toddler Stool Scale (BITTS) was developed, consisting of 7 photograps of diapers containing stools of infants and toddlers. We aimed to evaluate inter-observer reliability of stool consistency assessment among parents, nurses and medical doctors using the BITTS. Method : In this multicenter cross-sectional study (2016-2017), Bitts photograps were rated according to the BSFS. The reliability of the BITTS was evaluated using the overall proportion of perfect agreement and the linearly weighted K statistic. What is known : - reliable assessment of stool consistency is important for evaluating children's defecation pattern and diagnosing gastrointestinal disorders. - the reliability of the Bristol Stool Form Scale, developed for adults, has been debated for young children who are non-toilet trained and wear diapers To get validation of the BITTS : - a non-toilet trained child makes stool in diaper - caregiver scores the aspect of the stool according to the BITTS - caregiver takes a picture of the diaper - after 1 monts she rescores the picture according to the BITTS


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date November 1, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 5 Years
Eligibility Inclusion Criteria:pictures of diapers with stool of all childeren who are non-toilet trained - Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Other:
validation of Bitts
No intervention, observation of photographs of stool

Locations

Country Name City State
Belgium UZ Brussel Brussels

Sponsors (1)

Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary to evaluate the inter-observer reliability of stool consistency stool of a non-toilet trained child wuk be scired by a caregiver according to the BITTS. Then the caregiver takes a picter of this diaper with stool. After 1 month she rescores the picter according to BITTS 6months