Constipation - Functional Clinical Trial
— BABITTOfficial title:
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
Verified date | December 2023 |
Source | Dalarna County Council, Sweden |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 293 |
Est. completion date | September 2025 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 2 Months |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | 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 |
Lead Sponsor | Collaborator |
---|---|
Dalarna County Council, Sweden | Center for Clinical Research Dalarna, Sweden, Göteborg University, Örebro University, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | 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 | |
Primary | Prevalence of functional constipation | Functional constipation, measured with validated questionnaires according to the ROME IV criteria | Up to 9 months of age | |
Primary | Prevalence of infant dyschezia | Infant dyschezia, measured with validated questionnaires according to the ROME IV criteria | Up to 9 months of age | |
Primary | 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 | Prevalence of functional constipation | Functional constipation, measured with validated questionnaires according to the ROME IV criteria. | Up to 4 years of age | |
Secondary | Prevalence of gastrointestinal symptoms | Gastrointestinal symptoms, measured with Pediatric Quality of Life Inventory Gastrointestinal Symptoms Module (PedsQL Gastro) | At 4 years of age | |
Secondary | Prevalence of stool toileting refusal | Stool toileting refusal, measured with validated questionnaire | At 4 years of age | |
Secondary | Prevalence of bladder dysfunction | Bladder dysfunction, measured with validated questionnaires according to International Childrens Continence Society (ICCS) definitions. | Up to 4 years of age. |
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