Clinical trial NCT04082689: Bowel And Bladder Function in Infant Toilet Training
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infantile Colic
Constipation - Functional
Bladder Dysfunction
Toilet Training
Keywords: Colic
Constipation
Bladder dysfunction
Toilet training
Lead sponsor: Dalarna County Council, Sweden
Sponsor class: OTHER
Collaborators: name: Center for Clinical Research Dalarna, Sweden
name: Örebro University, Sweden
name: Göteborg University
First posted: 2019-09-09
Enrollment: 293
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: Prevalence of functional constipation
timeFrame: Up to 9 months of age
measure: Prevalence of infant dyschezia
timeFrame: Up to 9 months of age
measure: Prevalence of infant colic
timeFrame: Up to 5 months of age
Secondary outcomes:
measure: Prevalence of functional constipation
timeFrame: Up to 4 years of age
measure: Prevalence of gastrointestinal symptoms
timeFrame: At 4 years of age
measure: Prevalence of stool toileting refusal
timeFrame: At 4 years of age
measure: Prevalence of bladder dysfunction
timeFrame: Up to 4 years of age.
Other outcomes:
measure: Infant-to-mother attachment
timeFrame: Up to 9 months of age
measure: Parental stress
timeFrame: Up to 2,5 years of age
Locations:
city: Borlänge
country: Sweden
facility: Unicare vårdcentral Borlänge
state: Dalarna
city: Borlänge
country: Sweden
facility: Vårdcentral Kvarnsveden
state: Dalarna
city: Falun
country: Sweden
facility: Elsborgs Familjecentral
state: Dalarna
city: Falun
country: Sweden
facility: Falu Vårdcentral
state: Dalarna
city: Leksand
country: Sweden
facility: Familjecentralen Bönan
state: Dalarna
city: Mora
country: Sweden
facility: Barnavårdscentral Mora
state: Dalarna
Study officials:
affiliation: Dalarna County Council, Sweden
name: Barbro Hedin Skogman, assoc. prof.
role: STUDY_DIRECTOR
References:
citation: 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.