Understanding quality of life in children with intestinal failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to quantify and describe the quality of life of children suffering from intestinal failure, while identifying the medical and socio-economic factors that influence their well-being. By utilizing data from multiple multidisciplinary intestinal failure centers across the United States and Canada, the study seeks to fill the knowledge gap regarding the specific challenges faced by these patients and their families. The focus is on health-related quality of life, which encompasses physical, psychological, and social aspects, as mortality rates have decreased and long-term morbidity has become a primary concern. Insights gained from this research could lead to improved support services and tailored medical treatments for pediatric intestinal failure patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting
• Connecticut Children's Medical Center
  Hartford, Connecticut, United States Recruiting
• Lurie Children's Hospital
  Chicago, Illinois, United States Recruiting
• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting
• C.S. Mott Children's Hospital
  Ann Arbor, Michigan, United States Recruiting
• St. Louis Children's Hospital
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Patrick J Javid, MD — Seattle Children's Hospital
• Study coordinator: Biren P Modi, MD MPH
• Email: biren.modi@childrens.harvard.edu
• Phone: 857-218-4651

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using KiteLock 4% EDTA to prevent catheter blockages in children with intestinal failure

  This study is testing whether a new catheter lock solution can help prevent blockages in central venous catheters for children with intestinal failure who need total parenteral nutrition.

  Recruiting at 7 sites SterileCare Inc. · Boston, Massachusetts and 7 other locations · NCT05879835

• Resting energy tests in people with normal digestion vs. intestinal failure

  This study tests resting energy expenditure in adults with and without intestinal failure to help tailor nutrition needs.

  Recruiting Institute of Oncology Ljubljana · Ljubljana · NCT07714499

• Anabolic response to IV amino acids in people with chronic intestinal failure

  This will test whether giving IV amino acids helps people with chronic intestinal failure on home parenteral nutrition build and maintain body protein and better match their individual protein needs.

  Recruiting Institute of Oncology Ljubljana · Ljubljana · NCT07422792

• AI-guided IV nutrition for newborns in the NICU

  This project will try an AI tool that suggests IV nutrition (TPN) for newborns in the NICU who cannot feed by mouth to see if it helps clinicians order the right formula more quickly and accurately.

  Recruiting Takeoff41, Inc. · Stanford, California · NCT07414576

• Observing pediatric patients who have stopped using parenteral nutrition

  This study looks at children who have stopped using parenteral nutrition to see what health issues they might face afterward and to find out which kids are most at risk.

  Recruiting The Hospital for Sick Children · Toronto, Ontario · NCT06525753

• Using ultrasound-based measures to check liver health in children

  This project will test whether ultrasound techniques like shear wave elastography, shear wave dispersion, and attenuation imaging can noninvasively characterize liver disease in children who have or may have liver problems.

  Recruiting Sahlgrenska University Hospital · Gothenburg, Västra Götaland County · NCT07202910

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.