Measurement of Body Composition by Air Displacement Plethysmography in Pediatric Intestinal Failure Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02561819|
Recruitment Status : Completed
First Posted : September 28, 2015
Last Update Posted : December 16, 2019
|Condition or disease|
|Short Bowel Syndrome|
Infants and children with intestinal failure (IF) require prolonged periods of parenteral nutrition (PN) for sustenance and growth until intestinal adaptation allows adequate enteral intake. Lean body mass (or muscle mass) preservation and accrual is an important goal during this phase of nutritional rehabilitation. However, lean body mass is not accurately measured by currently available anthropometric techniques. Thus, despite weight gain, muscle mass depletion can remain undetected.
Little data exist in the field of measuring body composition in patients with intestinal failure, where changes in body weight are commonly taken to indirectly measure gastrointestinal absorptive function. Body composition analysis is of particular importance in the management of these patients, since it can help guide medical, surgical and/or nutrition interventions, including titration of enteral or parenteral nutrition. To the investigators' knowledge there are no studies examining whether air-displacement plethysmography (ADP) is a valid measure of body composition in patients with intestinal failure.
The investigators propose a non-randomized, prospective cohort study to validate ADP as a measure of body composition in infants and children with IF.
The investigators will apply non-radioactive (stable) isotope techniques to examine the accuracy of ADP in measuring body composition in these children.
The investigators will also compare ADP with bioimpedance analysis and routine anthropometry. Additionally, if subjects have had a recent dual-energy X- ray absorptiometry (DXA) scan, the investigators will compare the ADP estimates of body composition to those obtained from DXA. The investigators hypothesize that ADP is a feasible and accurate technique for body composition measurements, and that the device can be used to serially measure lean body mass and fat mass changes in this cohort. If the feasibility and accuracy of ADP for body composition analysis can be demonstrated, the technique is likely to have wider applications in other pediatric illnesses.
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||Measurement of Body Composition by Air Displacement Plethysmography in Pediatric Intestinal Failure Patients|
|Actual Study Start Date :||November 2015|
|Actual Primary Completion Date :||February 2017|
|Study Completion Date :||December 2020|
- Body composition (percent body fat and fat-free mass) as measured by air displacement plethysmography in pediatric patients with intestinal failure on date of visit. [ Time Frame: Single Visit ]Body composition (percent body fat and fat-free mass) as measured by air displacement plethysmography in pediatric patients with intestinal failure will be compared to body composition measurements done by the deuterium dilution technique, DXA scan, and bioimpedance analysis.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561819
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Christopher Duggan, MD, MPH||Boston Children's Hospital|
|Principal Investigator:||Alexandra Carey, MD||Boston Children's Hospital|