Intestinal failure Intestinal failure
Conditions
Interventions
Not applicable.
Sponsors
Hospital for Sick Children, Toronto, Canada
Eligibility
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: PN graduates, i.e.: patients with a history of IF, defined as the reduction of functional intestinal mass below that which can sustain life, resulting in dependence on supplemental PN support for a minimum of 60 days within a 74 consecutive day interval(1), due to a primary GI disorder such as short bowel syndrome, motility disorders or enteropathies, who were followed by the GIFT team or IF team as an outpatient, who are weaned off PN at time of inclusion for at least 1 year, and are aged <18 years at time of inclusion.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: No consent provided. Patients who need to restart PN during the study period will still be part of the study since this is one of the outcomes of the study described at secondary outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the frequency of nutritional complications including poor growth, micronutrient deficiencies, poor bone health, abnormal body composition, and delayed pubertal development in PN graduates. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determine associations between clinical characteristics and complications as mentioned in primary and secondary objectives. Assess the occurrence of surgical complications in PN graduates. To assess the nature and severity of GI symptoms in PN graduates. Assess the use of GI medication and micronutrient supplements, and need for restart of oral nutrition, enteral nutrition or PN support in PN graduates. Assess handgrip strength in PN graduates and compare it to normative data. Assess physical activity levels in PN graduates and compare them to normative data. To assess the nature and severity of fatigue in PN graduates. To assess Health-related Quality of Life in PN graduates. Compare outcomes of PN graduates between the different centers. | — |
Countries
Canada, Netherlands, United Kingdom
Contacts
Public ContactM van Pieterson
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed