Bowel And Bladder Function in Infant Toilet Training

Not Applicable

Active, not recruiting

• Conditions: Infantile Colic; Bladder Dysfunction; Toilet Training; Constipation - Functional

• Registration Number: NCT04082689
• Lead Sponsor: Dalarna County Council, Sweden

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.

Study Timeline

• Study Start: 2019-04-18
• Study First Submitted: 2019-06-12
• Study First Submitted QC: 2019-09-06
• Study First Posted: 2019-09-09
• Primary Completion: 2022-06-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 293

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Prevalence of infant colic	Up to 5 months of age	Infant colic measured with validated questionnaires according to the ROME IV criteria, including a prospective 24h infant behavioral diary when infant colic is suspected
Prevalence of infant dyschezia	Up to 9 months of age	Infant dyschezia, measured with validated questionnaires according to the ROME IV criteria
Prevalence of functional constipation	Up to 9 months of age	Functional constipation, measured with validated questionnaires according to the ROME IV criteria

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Unicare vårdcentral Borlänge; 🇸🇪 Borlänge, Dalarna, Sweden

Vårdcentral Kvarnsveden; 🇸🇪 Borlänge, Dalarna, Sweden

Elsborgs Familjecentral; 🇸🇪 Falun, Dalarna, Sweden

Falu Vårdcentral; 🇸🇪 Falun, Dalarna, Sweden

Familjecentralen Bönan; 🇸🇪 Leksand, Dalarna, Sweden

Barnavårdscentral Mora; 🇸🇪 Mora, Dalarna, Sweden