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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infantile Colic
- Sponsor
- Dalarna County Council, Sweden
- Enrollment
- 293
- Locations
- 6
- Primary Endpoint
- Prevalence of infant colic
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Barbro Hedin Skogman
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
Dalarna County Council, Sweden
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
Outcomes
Primary Outcomes
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
Prevalence of infant dyschezia
Time Frame: Up to 9 months of age
Infant dyschezia, measured with validated questionnaires according to the ROME IV criteria
Prevalence of functional constipation
Time Frame: Up to 9 months of age
Functional constipation, measured with validated questionnaires according to the ROME IV criteria
Secondary Outcomes
- Prevalence of stool toileting refusal(At 4 years of age)
- Prevalence of functional constipation(Up to 4 years of age)
- Prevalence of gastrointestinal symptoms(At 4 years of age)
- Prevalence of bladder dysfunction(Up to 4 years of age.)