Intestinal FailureNCT06525753
Weaning is Winning? (WeWin Study)
An observational study of Intestinal Failure and Parenteral Nutrition, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
We propose a multicenter prospective study on pediatric patients with intestinal failure (IF) who weaned off parenteral nutrition (PN). Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Intestinal Failure, Parenteral Nutrition
- What is being tested?
- Weaning off Parenteral Nutrition
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2024to 1 Jun 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Parenteral Nutrition graduates for at least 1 year, with a history of intestinal failure.
- Age <18 years at time of inclusion.
Who cannot join
- No consent provided.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Jessie Hulst, MD, PhD, jessie.hulst@sickkids.ca
Zujaja-Tul-Noor Zujaja-Tul-Noor, MSc, zujaja.tul-noor@sickkids.ca
About this study
Official title: 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).
Read the 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.
- Conditions
- Intestinal Failure, Parenteral Nutrition
- Being tested
- Weaning off Parenteral Nutrition
- Keywords
- Quality of Life, Pediatric
- Medical subject headings
- Intestinal Failure, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weaning off Parenteral NutritionOther
pediatric intestinal failure patients who have been weaned off parenteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| SickKids | Patients recruited from the Hospital for Sick Children (SickKids), Toronto, Canada Receives: Other: Weaning off Parenteral Nutrition | |
| Erasmus | Patients recruited from the Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands Receives: Other: Weaning off Parenteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 1 year after weaning off PN to 18 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Principal investigator, Jessie Hulst, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525753
- Sponsor's protocol ID
- 1000080824
- Status last verified
- Jun 2026
- First submitted
- 24 Jul 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning is Winning? (WeWin Study): Are Parenteral Nutrition (PN) Graduates Growing up Healthy?
- ClinicalTrials.gov ID
- NCT06525753
- Acronym / sponsor ID
- 1000080824
- Conditions
- Intestinal Failure, Parenteral Nutrition
- Keywords
- Quality of Life, Pediatric
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2034 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose a multicenter prospective study on pediatric patients with intestinal failure (IF) who weaned off parenteral nutrition (PN).
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SickKids | – | Other: Weaning off Parenteral NutritionPatients recruited from the Hospital for Sick Children (SickKids), Toronto, Canada |
| Erasmus | – | Other: Weaning off Parenteral NutritionPatients recruited from the Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Parenteral Nutrition graduates for at least 1 year, with a history of intestinal failure.
- Age <18 years at time of inclusion.
Key exclusion criteria (1 listed)
- No consent provided.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weaning off Parenteral Nutritionpediatric intestinal failure patients who have been weaned off parenteral nutrition | Other | Erasmus, SickKids |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Failure and Parenteral Nutrition, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: From 1 year after weaning off PN to 18 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.