NCT04629014 Prospective Multisite Study of Quality of Life in Pediatric Intestinal Failure
| NCT ID | NCT04629014 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | Pediatric Intestinal Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 750 participants |
| Start Date | 2020-02-27 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 750 participants in total. It began in 2020-02-27 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study proposes to quantify and describe the quality of life of children with intestinal failure, and to identify the medical and socio-economic factors that impact this quality of life, using data from multiple multidisciplinary intestinal failure centers across the United States and Canada specializing in the care of these participants.
Eligibility Criteria
Inclusion Criteria: * Participants will be followed in a participating institution's intestinal rehabilitation program * Participants will have a diagnosis of intestinal failure due to functional or structural intestinal dysfunction with current or prior history of specialized nutritional support (parenteral nutrition requirement for 60 out of 74 consecutive days) * Participants will be age 6 months to 25 years old. * Parents/caregivers must be able to complete questionnaire without assistance. * English or Spanish speaking Exclusion Criteria: * Participants aged less than 6 months or greater than 25 years will not be included in this study * Participants will not be enrolled less than 3 months from index admission or initial outpatient evaluation * Participants will not be enrolled less than 1 month from inpatient admission (any admission greater than 24 hours in duration) * Participants will not be enrolled less than 1 month from any operative intervention requiring general anesthesia. * Primary language other than English or Spanish. * Participants who have a currently functional small bowel, liver/small bowel or multivisceral transplant * While other major co-morbidities may be excluded at a later time during data analysis, or may be analyzed as a specific sub-group, they will not be excluded outright. For example, participants with global developmental delay may have parent surveys only, and therefore would need to be excluded from paired analysis of proxy vs. participant perception of HRQOL
Contact & Investigator
Patrick J Javid, MD
PRINCIPAL INVESTIGATOR
Seattle Children's Hospital
Frequently Asked Questions
Who can join the NCT04629014 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 25 Years, studying Pediatric Intestinal Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04629014 currently recruiting?
Yes, NCT04629014 is actively recruiting participants. Contact the research team at biren.modi@childrens.harvard.edu for enrollment information.
Where is the NCT04629014 trial being conducted?
This trial is being conducted at Birmingham, United States, Aurora, United States, Hartford, United States, Chicago, United States and 10 additional locations.
Who is sponsoring the NCT04629014 clinical trial?
NCT04629014 is sponsored by Boston Children's Hospital. The principal investigator is Patrick J Javid, MD at Seattle Children's Hospital. The trial plans to enroll 750 participants.