Bowel And Bladder Function in Infant Toilet Training

Constipation - Functional Clinical Trial

— BABITT  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04082689
• Other study ID #: BABITT-01
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Bladder Dysfunction
• Colic
• Constipation
• Constipation - Functional
• Infantile Colic
• Toilet Training

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.