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Active, not recruiting Not applicable

Bowel And Bladder Function in Infant Toilet Training

NCT04082689 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2019-04-18
Last updated
2025-02-21

Condition(s) studied

Infantile ColicConstipation - FunctionalBladder DysfunctionToilet Training

Investigational drug(s) / intervention(s)

Assisted Infant Toilet Training

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.

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
2 Months
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Prevalence of functional constipation — Up to 9 months of age
    Functional constipation, measured with validated questionnaires according to the ROME IV criteria
  • Prevalence of infant dyschezia — Up to 9 months of age
    Infant dyschezia, measured with validated questionnaires according to the ROME IV criteria
  • Prevalence of infant colic — Up to 5 months of age
    Infant colic measured with validated questionnaires according to the ROME IV criteria, including a prospective 24h infant behavioral diary when infant colic is suspected

Trial sites (6)

FacilityCityRegionStatus
Unicare vårdcentral Borlänge Borlänge Dalarna County
Vårdcentral Kvarnsveden Borlänge Dalarna County
Elsborgs Familjecentral Falun Dalarna County
Falu Vårdcentral Falun Dalarna County
Familjecentralen Bönan Leksand Dalarna County
Barnavårdscentral Mora Mora Dalarna County
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04082689 on ClinicalTrials.gov ↗ ← All trials in Sweden