Validation BITSS Brussels Infant Stool Scale | NCT03705689

Studies
Validation BITSS Brussels Infant Stool Scale

NCT03705689

Sponsor

Universitair Ziekenhuis Brussel

Status

Completed

Last Update Posted

Nov 5, 2020Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Validation of BITTS

Interventions

validation of Bitts

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2018Actual

Primary Completion Date

Apr 30, 2019Actual

Completion Date

Nov 1, 2019Actual

First Submitted Date

Oct 8, 2018

First Submission Date that Met QC Criteria

Oct 10, 2018

First Posted Date

Oct 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2020

Last Update Posted Date

Nov 5, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yvan Vandenplas, head of Clinic, Universitair Ziekenhuis BrusselPrincipal Investigator

Lead Sponsor

Universitair Ziekenhuis BrusselOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

validation of stool scale in toddlers

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
validation of Bitts	Other	No intervention, observation of photographs of stool

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

all children who are non-toilet trained

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Brussel		Brussels		1090	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided