Weaning is Winning? (WeWin Study)

October 15, 2024 updated by: Jessie Hulst, The Hospital for Sick Children

Weaning is Winning? (WeWin Study): Are Parenteral Nutrition (PN) Graduates Growing Up Healthy?

We propose a multicenter prospective study on pediatric patients with intestinal failure (IF) who weaned off parenteral nutrition (PN).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Children with IF depend on PN. This is associated with frequent and various complications such as metabolic bone disease, micronutrient deficiencies and abnormal body composition. Due to advancements in care, many patients with IF are able to wean off PN; they are so called PN graduates. It is currently not well known how often complications do occur after weaning off PN, and which patients are at highest risk of developing these complications.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  • Parenteral Nutrition graduates for at least 1 year, with a history of intestinal failure.
  • Age <18 years at time of inclusion.

Exclusion criteria:

  • No consent provided.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SickKids
Patients recruited from the Hospital for Sick Children (SickKids), Toronto, Canada
Other: Weaning off Parenteral Nutrition
pediatric intestinal failure patients who have been weaned off parenteral nutrition
Erasmus
Patients recruited from the Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands
Other: Weaning off Parenteral Nutrition
pediatric intestinal failure patients who have been weaned off parenteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: From 1 year after weaning off PN to 18 years of age
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

Erasmus University Medical Center (Erasmus MC) - Sophia Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2034

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 15, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000080824

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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