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Active, Not Recruiting

NCT Number: NCT04082689

Bowel And Bladder Function in Infant Toilet Training

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Infantile Colic Bladder Dysfunction Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Constipation Constipation - Functional Infant, Newborn, Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Toilet Training

Age range

Up to 2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unicare vårdcentral Borlänge, Borlänge, Dalarna County, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Elimination Communication

Primary outcomes

  1. Prevalence of functional constipation

    Time frame: Up to 9 months of age

    Functional constipation, measured with validated questionnaires according to the ROME IV criteria

  2. Prevalence of infant dyschezia

    Time frame: Up to 9 months of age

    Infant dyschezia, measured with validated questionnaires according to the ROME IV criteria

  3. Prevalence of infant colic

    Time frame: 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

Secondary outcomes

  1. Prevalence of functional constipation

    Time frame: Up to 4 years of age

    Functional constipation, measured with validated questionnaires according to the ROME IV criteria.

  2. Prevalence of gastrointestinal symptoms

    Time frame: At 4 years of age

    Gastrointestinal symptoms, measured with Pediatric Quality of Life Inventory Gastrointestinal Symptoms Module (PedsQL Gastro)

  3. Prevalence of stool toileting refusal

    Time frame: At 4 years of age

    Stool toileting refusal, measured with validated questionnaire

  4. Prevalence of bladder dysfunction

    Time frame: Up to 4 years of age.

    Bladder dysfunction, measured with validated questionnaires according to International Childrens Continence Society (ICCS) definitions.

Other outcomes

  1. Infant-to-mother attachment

    Time frame: Up to 9 months of age

    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.

  2. Parental stress

    Time frame: Up to 2,5 years of age

    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.

Sponsors and collaborators

Lead sponsor

Dalarna County Council, Sweden

Other

Collaborators

  • Center for Clinical Research Dalarna, Sweden
  • Göteborg University
  • Örebro University, Sweden

Registry information

Official study 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

Acronym: BABITT

Important dates

Study start
2019
Primary completion
2022
Study completion
2025
First posted
Sep 9, 2019
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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