Weaning is Winning? (WeWin Study)
1 other identifier
observational
120
1 country
1
Brief Summary
We propose a multicenter prospective study on pediatric patients with intestinal failure (IF) who weaned off parenteral nutrition (PN).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2024
CompletedFirst Submitted
Initial submission to the registry
July 24, 2024
CompletedFirst Posted
Study publicly available on registry
July 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2034
October 17, 2024
July 1, 2024
5 years
July 24, 2024
October 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complications
Assess the frequency of nutritional complications including poor growth, micronutrient deficiencies, poor bone health, abnormal body composition, and delayed pubertal development in PN graduates.
From 1 year after weaning off PN to 18 years of age
Study Arms (2)
SickKids
Patients recruited from the Hospital for Sick Children (SickKids), Toronto, Canada
Erasmus
Patients recruited from the Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands
Interventions
pediatric intestinal failure patients who have been weaned off parenteral nutrition
Eligibility Criteria
Parenteral Nutrition graduates, i.e.: patients weaned off Parenteral Nutrition at time of inclusion for at least 1 year, with a history of intestinal failure, defined as dependence on supplemental PN support for a minimum of 60 days within a 74 consecutive day interval and followed by the Group for Improvement of Intestinal Function and Treatment (GIFT) team (SickKids) or IF team (Erasmus MC) as an outpatient.
You may qualify if:
- Parenteral Nutrition graduates for at least 1 year, with a history of intestinal failure.
You may not qualify if:
- No consent provided.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Physician
Study Record Dates
First Submitted
July 24, 2024
First Posted
July 29, 2024
Study Start
June 1, 2024
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
June 1, 2034
Last Updated
October 17, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share
All participants will be assigned a unique study ID (identification) known only to the study investigators/coordinators. The unique study IDs will only be identifiable through an encrypted master-linking log stored on a secure hospital server and shared folder that is only accessible to designated study staff on each site.