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| Name | Class |
|---|---|
| Center for Clinical Research Dalarna, Sweden | OTHER |
| Örebro University, Sweden | OTHER |
| Göteborg University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assisted Infant Toilet Training-Group A | Active Comparator | 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. |
|
| Assisted Infant Toilet Training- Group B | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assisted Infant Toilet Training | Behavioral | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbro Hedin Skogman, assoc. prof. | Dalarna County Council, Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unicare vårdcentral Borlänge | Borlänge | Dalarna County | 78460 | Sweden | ||
| Vårdcentral Kvarnsveden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41249012 | Derived | Nilsson T, Leijon A, LoMartire R, De la Calle Dahlstedt S, Sillen U, Hellstrom AL, Skogman BH. Assisted infant toilet training and the prevalence of functional gastrointestinal disorders up to the age of 9 months: a randomised, controlled trial. Arch Dis Child. 2026 Feb 19;111(3):238-244. doi: 10.1136/archdischild-2025-328792. | |
| 35590259 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 29, 2023 | Dec 3, 2023 | Prot_007.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 29, 2023 | Dec 3, 2023 | SAP_008.pdf |
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| ID | Term |
|---|---|
| D003085 | Colic |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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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).
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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.
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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. |
| 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 |
| Borlänge |
| Dalarna County |
| Sweden |
| Elsborgs Familjecentral | Falun | Dalarna County | 79151 | Sweden |
| Falu Vårdcentral | Falun | Dalarna County | 79170 | Sweden |
| Familjecentralen Bönan | Leksand | Dalarna County | 79331 | Sweden |
| Barnavårdscentral Mora | Mora | Dalarna County | 79230 | Sweden |
| 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |