Weaning is Winning? (WeWin Study)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-18
SponsorThe Hospital for Sick Children
About this trial
We propose a multicenter prospective study on pediatric patients with intestinal failure (IF) who weaned off parenteral nutrition (PN).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Parenteral Nutrition graduates for at least 1 year, with a history of intestinal failure.
Age <18 years at time of inclusion.
Disqualifiers
No consent provided.
Trial population
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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Weaning off Parenteral Nutrition
Other interventionpediatric intestinal failure patients who have been weaned off parenteral nutrition
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: SickKids1 intervention
Group B: Erasmus1 intervention
Trial outcomes
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.
Time frame
From 1 year after weaning off PN to 18 years of ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Hospital for Sick Children
Lead sponsor
Erasmus Medical Center
Collaborator
Source ClinicalTrials.gov