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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04082689
Other study ID # BABITT-01
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 18, 2019
Est. completion date September 2025

Study information

Verified date December 2023
Source Dalarna County Council, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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

Study Design


Intervention

Behavioral:
Assisted Infant Toilet Training
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.

Locations

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

Sponsors (4)

Lead Sponsor Collaborator
Dalarna County Council, Sweden Center for Clinical Research Dalarna, Sweden, Göteborg University, Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

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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