Bowel And Bladder Function in Infant Toilet Training

NCT04082689 | Active Not Recruiting

• 1 other identifier: BABITT-01
• Study Type: interventional
• Target: 293
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

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

Keywords

Colic; Constipation; Bladder dysfunction; Toilet training

Outcome Measures

Primary Outcomes (3)

• Prevalence of functional constipation

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

  Up to 9 months of age

• Prevalence of infant dyschezia

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

  Up to 9 months of age

• 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 Outcomes (4)

• Prevalence of functional constipation

  Up to 4 years of age

• Prevalence of gastrointestinal symptoms

  At 4 years of age

• Prevalence of stool toileting refusal

  At 4 years of age

• Prevalence of bladder dysfunction

  Up to 4 years of age.

Other Outcomes (2)

• Infant-to-mother attachment

  Up to 9 months of age

• Parental stress

  Up to 2,5 years of age

Study Arms (2)

Assisted Infant Toilet Training-Group A

ACTIVE COMPARATOR

Parents to Children randomized to group A will be instructed in how infant toilet training is performed by the investigators. They receive a book in Swedish concerning infant toilet training and a brief summary of the book made by the investigators. The parents are encouraged to begin infant toilet training as early as possible, 0-2 months of age The definition of adherence to the intervention is to perform at least one attempt a day of infant toilet training (without the requirement of a successful outcome) on at least 5 out of 7 days per week.

Behavioral: Assisted Infant Toilet Training

Assisted Infant Toilet Training- Group B

ACTIVE COMPARATOR

Parents to Children randomized to group B will be instructed in how infant toilet training is performed by the co-workers doing the ultrasound measure of rectal diameter at 9 months. They receive a book in Swedish concerning infant toilet training and a brief summary of it made by the investigators. They start infant toilet training at the age of 10-11 months. The definition of adherence to the intervention is to perform at least one attempt a day of infant toilet training (without the requirement of a successful outcome) on at least 5 out of 7 days per week.

Behavioral: Assisted Infant Toilet Training

Interventions

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.

Also known as: Elimination Communication

Assisted Infant Toilet Training- Group B; Assisted Infant Toilet Training-Group A

Eligibility Criteria

• Age: Up to 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Full-term infant (born at gestational week 37+0 to 41+6)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dalarna County Council, Sweden: lead
• Center for Clinical Research Dalarna, Sweden: collaborator
• Örebro University, Sweden: collaborator
• Göteborg University: collaborator

Study Sites (6)

Unicare vårdcentral Borlänge

Borlänge, Dalarna County, 78460, Sweden

Location

Vårdcentral Kvarnsveden

Borlänge, Dalarna County, Sweden

Location

Elsborgs Familjecentral

Falun, Dalarna County, 79151, Sweden

Location

Falu Vårdcentral

Falun, Dalarna County, 79170, Sweden

Location

Familjecentralen Bönan

Leksand, Dalarna County, 79331, Sweden

Location

Barnavårdscentral Mora

Mora, Dalarna County, 79230, Sweden

Location

Related Publications (2)

• Nilsson T, Leijon A, LoMartire R, De la Calle Dahlstedt S, Sillen U, Hellstrom AL, Skogman BH. Assisted infant toilet training and the prevalence of functional gastrointestinal disorders up to the age of 9 months: a randomised, controlled trial. Arch Dis Child. 2025 Nov 17:archdischild-2025-328792. doi: 10.1136/archdischild-2025-328792. Online ahead of print.

  PMID: 41249012 DERIVED

• Nilsson T, Leijon A, Sillen U, Hellstrom AL, Skogman BH. Bowel and bladder function in infant toilet training (BABITT) - protocol for a randomized, two-armed intervention study. BMC Pediatr. 2022 May 19;22(1):294. doi: 10.1186/s12887-022-03355-6.

  PMID: 35590259 DERIVED

MeSH Terms

Conditions

Colic; Constipation

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Barbro Hedin Skogman, assoc. prof.

  Dalarna County Council, Sweden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The group allocation of the participating Children will be masked to the co-workers performing the ultrasound measurement of rectal diameter at 9 months and 4 years of age.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant at the Department of Paediatrics, Falun Hospital, Associate professor at Örebro Universitet, post-doctoral researcher at the Center for Clinical Research (CKF) Dalarna, Sweden

Model Details: A randomized controlled trial (RCT) where one group of children who begin assisted infant toilet training at age 0-2 months (group A) is compared to a group of children who begin assisted infant toilet training at 10-11 months (group B).

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: September 9, 2019
• Study Start: April 18, 2019
• Primary Completion: June 30, 2022
• Study Completion: September 1, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (6)