Bowel And Bladder Function in Infant Toilet Training

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Constipation - Functional, Infantile Colic, Bladder Dysfunction, Toilet Training

Intervention / Treatment
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* Behavioral: Assisted Infant Toilet Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Assisted Infant Toilet Training-Group A<br>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<br>* 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.<br>* Other names: Elimination Communication;|
| Active Comparator: Assisted Infant Toilet Training- Group B<br>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<br>* 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.<br>* Other names: Elimination Communication;|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colic, Constipation, Bladder dysfunction, Toilet training