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| Name | Class |
|---|---|
| Erasmus Medical Center | OTHER |
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We propose a multicenter prospective study on pediatric patients with intestinal failure (IF) who weaned off parenteral nutrition (PN).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weaning off Parenteral Nutrition | Other | pediatric intestinal failure patients who have been weaned off parenteral nutrition |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
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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| ID | Term |
|---|---|
| D000090124 | Intestinal Failure |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |