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Bowel And Bladder Function in Infant Toilet Training (BABITT)

Primary Purpose

Infantile Colic, Constipation - Functional, Bladder Dysfunction

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Assisted Infant Toilet Training
Sponsored by
Dalarna County Council, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infantile Colic focused on measuring Colic, Constipation, Bladder dysfunction, Toilet training

Eligibility Criteria

undefined - 2 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Full-term infant (born at gestational week 37+0 to 41+6)

Exclusion Criteria:

  • Infants with malformations or disorders that may affect the gastrointestinal or urinary tract in any relevant way
  • Infants born small for gestational age (SGA), < - 2 standard deviation
  • Parents with insufficient understanding of the Swedish language
  • Infants older than 2 months, 1 week and 6 days at inclusion

Sites / Locations

  • Unicare vårdcentral Borlänge
  • Vårdcentral Kvarnsveden
  • Elsborgs Familjecentral
  • Falu Vårdcentral
  • Familjecentralen Bönan
  • Barnavårdscentral Mora

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Assisted Infant Toilet Training-Group A

Assisted Infant Toilet Training- Group B

Arm Description

Parents to Children randomized to group A will be instructed in how infant toilet training is performed by the investigators. They receive a book in Swedish concerning infant toilet training and a brief summary of the book made by the investigators. The parents are encouraged to begin infant toilet training as early as possible, 0-2 months of age The definition of adherence to the intervention is to perform at least one attempt a day of infant toilet training (without the requirement of a successful outcome) on at least 5 out of 7 days per week.

Parents to Children randomized to group B will be instructed in how infant toilet training is performed by the co-workers doing the ultrasound measure of rectal diameter at 9 months. They receive a book in Swedish concerning infant toilet training and a brief summary of it made by the investigators. They start infant toilet training at the age of 10-11 months. The definition of adherence to the intervention is to perform at least one attempt a day of infant toilet training (without the requirement of a successful outcome) on at least 5 out of 7 days per week.

Outcomes

Primary Outcome Measures

Prevalence of functional constipation
Functional constipation, measured with validated questionnaires according to the ROME IV criteria
Prevalence of infant dyschezia
Infant dyschezia, measured with validated questionnaires according to the ROME IV criteria
Prevalence of infant colic
Infant colic measured with validated questionnaires according to the ROME IV criteria, including a prospective 24h infant behavioral diary when infant colic is suspected

Secondary Outcome Measures

Prevalence of functional constipation
Functional constipation, measured with validated questionnaires according to the ROME IV criteria.
Prevalence of gastrointestinal symptoms
Gastrointestinal symptoms, measured with Pediatric Quality of Life Inventory Gastrointestinal Symptoms Module (PedsQL Gastro)
Prevalence of stool toileting refusal
Stool toileting refusal, measured with validated questionnaire
Prevalence of bladder dysfunction
Bladder dysfunction, measured with validated questionnaires according to International Childrens Continence Society (ICCS) definitions.

Full Information

First Posted
June 12, 2019
Last Updated
August 8, 2022
Sponsor
Dalarna County Council, Sweden
Collaborators
Center for Clinical Research Dalarna, Sweden, Örebro University, Sweden, Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT04082689
Brief Title
Bowel And Bladder Function in Infant Toilet Training
Acronym
BABITT
Official Title
Bowel And Bladder Function in Infant Toilet Training- a Randomized Intervention Study to Investigate the Efficacy of Assisted Infant Toilet Training on Preventing Functional Gastrointestinal and Urinary Tract Disorders up to 4 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 18, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dalarna County Council, Sweden
Collaborators
Center for Clinical Research Dalarna, Sweden, Örebro University, Sweden, Göteborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall purpose is to assess whether assisted infant toilet training during the first year of life can prevent functional gastrointestinal and urinary tract disorders up to 4 year of age. Healthy Swedish children will be randomized to start assisted infant toilet training at 0-2 months of age or at 10-11 months of age. The toilet training process will be described including mother-to-infant attachment and parental stress.
Detailed Description
The mastery of toilet training is an important developmental milestone for children and parents. The age at which children start toilet training has increased during the last decades in the Western world. 50 years ago most children were out of nappies by 1,5 years of age. Today, wearing nappies by 3-4 years of age is considered normal. Meanwhile an increase in functional gastrointestinal and urinary tract disorders and toileting problems is reported by health care professionals. A randomized multicenter intervention study is conducted at Child Health Care Centers in Sweden to investigate whether assisted infant toilet training initiated during the first year of life can prevent functional bowel and bladder disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Colic, Constipation - Functional, Bladder Dysfunction, Toilet Training
Keywords
Colic, Constipation, Bladder dysfunction, Toilet training

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled trial (RCT) where one group of children who begin assisted infant toilet training at age 0-2 months (group A) is compared to a group of children who begin assisted infant toilet training at 10-11 months (group B).
Masking
Outcomes Assessor
Masking Description
The group allocation of the participating Children will be masked to the co-workers performing the ultrasound measurement of rectal diameter at 9 months and 4 years of age.
Allocation
Randomized
Enrollment
293 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Assisted Infant Toilet Training-Group A
Arm Type
Active Comparator
Arm Description
Parents to Children randomized to group A will be instructed in how infant toilet training is performed by the investigators. They receive a book in Swedish concerning infant toilet training and a brief summary of the book made by the investigators. The parents are encouraged to begin infant toilet training as early as possible, 0-2 months of age The definition of adherence to the intervention is to perform at least one attempt a day of infant toilet training (without the requirement of a successful outcome) on at least 5 out of 7 days per week.
Arm Title
Assisted Infant Toilet Training- Group B
Arm Type
Active Comparator
Arm Description
Parents to Children randomized to group B will be instructed in how infant toilet training is performed by the co-workers doing the ultrasound measure of rectal diameter at 9 months. They receive a book in Swedish concerning infant toilet training and a brief summary of it made by the investigators. They start infant toilet training at the age of 10-11 months. The definition of adherence to the intervention is to perform at least one attempt a day of infant toilet training (without the requirement of a successful outcome) on at least 5 out of 7 days per week.
Intervention Type
Behavioral
Intervention Name(s)
Assisted Infant Toilet Training
Other Intervention Name(s)
Elimination Communication
Intervention Description
The parents learn to sensitively respond to the child's routines and signals of elimination needs.The child's ability to convey the need for bowel and bladder evacuation is enhanced through responsive interaction so that a kind of assisted dryness is developed. The infant is held "squatting" over a potty or basin, while older children sit on the potty.
Primary Outcome Measure Information:
Title
Prevalence of functional constipation
Description
Functional constipation, measured with validated questionnaires according to the ROME IV criteria
Time Frame
Up to 9 months of age
Title
Prevalence of infant dyschezia
Description
Infant dyschezia, measured with validated questionnaires according to the ROME IV criteria
Time Frame
Up to 9 months of age
Title
Prevalence of infant colic
Description
Infant colic measured with validated questionnaires according to the ROME IV criteria, including a prospective 24h infant behavioral diary when infant colic is suspected
Time Frame
Up to 5 months of age
Secondary Outcome Measure Information:
Title
Prevalence of functional constipation
Description
Functional constipation, measured with validated questionnaires according to the ROME IV criteria.
Time Frame
Up to 4 years of age
Title
Prevalence of gastrointestinal symptoms
Description
Gastrointestinal symptoms, measured with Pediatric Quality of Life Inventory Gastrointestinal Symptoms Module (PedsQL Gastro)
Time Frame
At 4 years of age
Title
Prevalence of stool toileting refusal
Description
Stool toileting refusal, measured with validated questionnaire
Time Frame
At 4 years of age
Title
Prevalence of bladder dysfunction
Description
Bladder dysfunction, measured with validated questionnaires according to International Childrens Continence Society (ICCS) definitions.
Time Frame
Up to 4 years of age.
Other Pre-specified Outcome Measures:
Title
Infant-to-mother attachment
Description
Infant-to-mother attachment, measured with Maternal Postnatal Attachment Scale (MPAS). It contains 19 issues, questions are scored 1-5. Total score is calculated by adding scores on all issues. Scale range for total score is 19-95. High score indicates higher mother-to-infant attachment.
Time Frame
Up to 9 months of age
Title
Parental stress
Description
Parental stress, measured with Swedish Parental Stress Questionnaire (SPSQ). It contains 34 issues each scoring 1-5. Total score is calculated as an average on answers (1-5) on all issues. Scale range for total score is 34-170. High score indicates higher parental stress.
Time Frame
Up to 2,5 years of age

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Full-term infant (born at gestational week 37+0 to 41+6) Exclusion Criteria: Infants with malformations or disorders that may affect the gastrointestinal or urinary tract in any relevant way Infants born small for gestational age (SGA), < - 2 standard deviation Parents with insufficient understanding of the Swedish language Infants older than 2 months, 1 week and 6 days at inclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbro Hedin Skogman, assoc. prof.
Organizational Affiliation
Dalarna County Council, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Unicare vårdcentral Borlänge
City
Borlänge
State/Province
Dalarna
ZIP/Postal Code
78460
Country
Sweden
Facility Name
Vårdcentral Kvarnsveden
City
Borlänge
State/Province
Dalarna
Country
Sweden
Facility Name
Elsborgs Familjecentral
City
Falun
State/Province
Dalarna
ZIP/Postal Code
79151
Country
Sweden
Facility Name
Falu Vårdcentral
City
Falun
State/Province
Dalarna
ZIP/Postal Code
79170
Country
Sweden
Facility Name
Familjecentralen Bönan
City
Leksand
State/Province
Dalarna
ZIP/Postal Code
79331
Country
Sweden
Facility Name
Barnavårdscentral Mora
City
Mora
State/Province
Dalarna
ZIP/Postal Code
79230
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35590259
Citation
Nilsson T, Leijon A, Sillen U, Hellstrom AL, Skogman BH. Bowel and bladder function in infant toilet training (BABITT) - protocol for a randomized, two-armed intervention study. BMC Pediatr. 2022 May 19;22(1):294. doi: 10.1186/s12887-022-03355-6.
Results Reference
derived

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Bowel And Bladder Function in Infant Toilet Training

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