Bladder Dysfunction, Constipation - Functional, Infantile Colic, Toilet Training
Conditions
Keywords
Colic, Constipation, Bladder dysfunction, Toilet training
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.
Interventions
BEHAVIORALAssisted 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.
Sponsors
Center for Clinical Research Dalarna, Sweden
Örebro University, Sweden
Göteborg University
Dalarna County Council, Sweden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
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).
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Prevalence of functional constipation | Up to 9 months of age | Functional constipation, measured with validated questionnaires according to the ROME IV criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of bladder dysfunction | Up to 4 years of age. | Bladder dysfunction, measured with validated questionnaires according to International Childrens Continence Society (ICCS) definitions. |
| Prevalence of stool toileting refusal | At 4 years of age | Stool toileting refusal, measured with validated questionnaire |
| Prevalence of functional constipation | Up to 4 years of age | Functional constipation, measured with validated questionnaires according to the ROME IV criteria. |
| Prevalence of gastrointestinal symptoms | At 4 years of age | Gastrointestinal symptoms, measured with Pediatric Quality of Life Inventory Gastrointestinal Symptoms Module (PedsQL Gastro) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Infant-to-mother attachment | 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. |
| Parental stress | 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. |
Countries
Sweden
Outcome results
None listed