Bowel And Bladder Function in Infant Toilet Training

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

293 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-18

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infantile Colic Constipation - Functional Bladder Dysfunction Toilet Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Assisted Infant Toilet Training-Group A

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.

Group Type ACTIVE_COMPARATOR

Assisted Infant Toilet Training

Intervention Type 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.

Assisted Infant Toilet Training- Group B

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.

Group Type ACTIVE_COMPARATOR

Assisted Infant Toilet Training

Intervention Type 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.

Interventions

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Assisted 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Elimination Communication

Eligibility Criteria

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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

Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR