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Bowel And Bladder Function in Infant Toilet Training

Study acronym: BABITT
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. 3 versions Re-verified since Oct 29, 2023, no change to tracked fieldsv15-v17
  2. Primary completion date changed from estimate of Jun 2022 to Jun 30, 2022v14
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 268 to confirmed 293
    • Primary completion date: Apr 2022 to Jun 2022
    • Site details revised at 6 of 6 sites
    v13
  4. Primary completion date: Mar 2022 to Apr 2022v12
  5. 3 versions Re-verified since Jun 2, 2021, no change to tracked fieldsv9-v11
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 3 to 6v8
  2. Re-verified, no change to tracked fieldsv7
  3. Study sites: 2 to 3
    • Study description revised
    • Eligibility criteria expanded, about 1 word
    v6
  4. Primary endpoints: 1 to 3v5 Show 4 more changesShow less
    • Interventions: Infant Toilet Training (Behavioral) to Assisted Infant Toilet Training (Behavioral)
    • Secondary endpoints: 2 to 4
    • Eligibility criteria expanded, about 1 word
    • Study description shortened, about 1 word
  5. Study sites: 1 to 2v4
  6. 2 versions Re-verified since Sep 20, 2019, no change to tracked fieldsv2-v3
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04082689
Lead Sponsor Dalarna County Council, Sweden
Collaborators: Center for Clinical Research Dalarna, Sweden, Örebro University, Sweden, Göteborg University
Conditions
(from sponsor)		 Infantile Colic, Constipation - Functional, Bladder Dysfunction, Toilet Training
Related terms Colic, Constipation
Enrollment 293 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov