Bowel And Bladder Function in Infant Toilet Training (BABITT)

Dalarna County Council, Sweden

Status: Active, not recruiting

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

Treatments: Behavioral: Assisted Infant Toilet Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04082689

BABITT-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 293 patients

Sex: All

Ages: Under 2 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

293 participants in 2 patient groups

Assisted Infant Toilet Training-Group A

Active Comparator group

Description:

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.

Treatment:

Behavioral: Assisted Infant Toilet Training

Assisted Infant Toilet Training- Group B

Active Comparator group

Description:

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.

Treatment:

Behavioral: Assisted Infant Toilet Training