Validation BITSS Brussels Infant Stool Scale

November 4, 2020 updated by: Yvan Vandenplas, Universitair Ziekenhuis Brussel
validation of stool scale in toddlers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1090
        • UZ Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 5 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

all children who are non-toilet trained

Description

Inclusion Criteria:pictures of diapers with stool of all childeren who are non-toilet trained

-

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to evaluate the inter-observer reliability of stool consistency
Time Frame: 6months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2018

Primary Completion (ACTUAL)

April 30, 2019

Study Completion (ACTUAL)

November 1, 2019

Study Registration Dates

First Submitted

October 8, 2018

First Submitted That Met QC Criteria

October 10, 2018

First Posted (ACTUAL)

October 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-365

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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