Bowel And Bladder Function in Infant Toilet Training (BABITT)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Infantile Colic; Constipation - Functional; Bladder Dysfunction; Toilet Training
• Intervention / Treatment: Behavioral: Assisted Infant Toilet Training

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.

• Study Type: Interventional
• Enrollment (Actual): 293
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Dalarna
    • Borlänge, Dalarna, Sweden, 78460
      • Unicare vårdcentral Borlänge
    • Borlänge, Dalarna, Sweden
      • Vårdcentral Kvarnsveden
    • Falun, Dalarna, Sweden, 79151
      • Elsborgs Familjecentral
    • Falun, Dalarna, Sweden, 79170
      • Falu Vårdcentral
    • Leksand, Dalarna, Sweden, 79331
      • Familjecentralen Bönan
    • Mora, Dalarna, Sweden, 79230
      • Barnavårdscentral Mora

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Assisted Infant Toilet Training-Group A; 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.	Behavioral: Assisted Infant Toilet Training; 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.; Other Names: Elimination Communication
Active Comparator: Assisted Infant Toilet Training- Group B; 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.	Behavioral: Assisted Infant Toilet Training; 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.; Other Names: Elimination Communication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of functional constipation	Functional constipation, measured with validated questionnaires according to the ROME IV criteria	Up to 9 months of age
Prevalence of infant dyschezia	Infant dyschezia, measured with validated questionnaires according to the ROME IV criteria	Up to 9 months of age
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	Up to 5 months of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of functional constipation	Functional constipation, measured with validated questionnaires according to the ROME IV criteria.	Up to 4 years of age
Prevalence of gastrointestinal symptoms	Gastrointestinal symptoms, measured with Pediatric Quality of Life Inventory Gastrointestinal Symptoms Module (PedsQL Gastro)	At 4 years of age
Prevalence of stool toileting refusal	Stool toileting refusal, measured with validated questionnaire	At 4 years of age
Prevalence of bladder dysfunction	Bladder dysfunction, measured with validated questionnaires according to International Childrens Continence Society (ICCS) definitions.	Up to 4 years of age.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant-to-mother attachment	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.	Up to 9 months of age
Parental stress	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.	Up to 2,5 years of age

Collaborators and Investigators

• Sponsor: Dalarna County Council, Sweden
• Collaborators: Göteborg University; Örebro University, Sweden; Center for Clinical Research Dalarna, Sweden
• Investigators: Study Director: Barbro Hedin Skogman, assoc. prof., Dalarna County Council, Sweden

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2019
• Primary Completion (Actual): June 30, 2022
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 3, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Constipation; Colic; Bladder dysfunction; Toilet training
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Infant, Newborn, Diseases; Constipation; Colic
• Other Study ID Numbers: BABITT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No