Bowel And Bladder Function in Infant Toilet Training
- Conditions
- Infantile ColicBladder DysfunctionToilet TrainingConstipation - Functional
- Interventions
- Behavioral: Assisted Infant Toilet Training
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 293
- Full-term infant (born at gestational week 37+0 to 41+6)
- 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
- Arm && Interventions
Group Intervention Description Assisted Infant Toilet Training- Group B Assisted Infant Toilet Training 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. Assisted Infant Toilet Training-Group A Assisted Infant Toilet Training 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.
- 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
Barnavårdscentral Mora
🇸🇪Mora, Dalarna, Sweden
Familjecentralen Bönan
🇸🇪Leksand, Dalarna, Sweden
Vårdcentral Kvarnsveden
🇸🇪Borlänge, Dalarna, Sweden
Falu Vårdcentral
🇸🇪Falun, Dalarna, Sweden
Elsborgs Familjecentral
🇸🇪Falun, Dalarna, Sweden