Measurement of Body Composition by Air Displacement Plethysmography in Pediatric Intestinal Failure Patients
NCT ID: NCT02561819
Last Updated: 2019-12-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
25 participants
Study Classification
OBSERVATIONAL
Study Start Date
2015-11-30
Study Completion Date
2020-12-31
Brief Summary
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This study will determine if air-displacement plethysmography (ADP) provides accurate measurement of body composition (percent body fat and fat-free mass) in pediatric patients with intestinal failure, as compared to body composition measured by alternative standard methods, including deuterium dilution, bioimpedance analysis (BIA), dual x-ray absorptiometry (DXA) when clinically indicated, and routine anthropometric measurements.
Detailed Description
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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.
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.
Conditions
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Short Bowel Syndrome
Keywords
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Short Bowel Syndrome
Congenital Short Bowel Syndrome
Body Composition
Parenteral Nutrition
Intestinal Failure
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients evaluated in the CAIR Program at Boston Children's Hospital will be eligible for participation if they meet the definition of short bowel syndrome and are under 18 years of age. Short bowel syndrome will be defined as a malabsorptive state resulting from congenital or acquired gastrointestinal disease leading to current dependence on parenteral nutrition for greater than or equal to 90 days. If the patient is on intravenous fluids, they must have a stable intravenous fluid regimen for at least 4 weeks prior to the study visit.
Exclusion Criteria
* age \< 2 years or ≥ 18 years
* presence of cardiac pacing device (BIA may theoretically interfere with pacer functioning)
* presence of any other electrical device that might interfere with the BIA such as implantable drug delivery pumps, vagal nerve stimulator and invasive cerebral perfusion monitor
* subjects will be excluded due to pregnancy
* subjects with ongoing fluid imbalance, clinically evident shifts in fluid compartments (e.g. edema, ascites) or with fluid resuscitation (defined as daily fluid intake more than 150% of maintenance or fluid boluses more than 20 ml/kg/day). Determination of fluid imbalance will be made by the physicians directly involved in the patient's care.
* presence of cardiac pacing device (BIA may theoretically interfere with pacer functioning)
* presence of any other electrical device that might interfere with the BIA such as implantable drug delivery pumps, vagal nerve stimulator and invasive cerebral perfusion monitor
* subjects will be excluded due to pregnancy
* subjects with ongoing fluid imbalance, clinically evident shifts in fluid compartments (e.g. edema, ascites) or with fluid resuscitation (defined as daily fluid intake more than 150% of maintenance or fluid boluses more than 20 ml/kg/day). Determination of fluid imbalance will be made by the physicians directly involved in the patient's care.
Minimum Eligible Age
2 Years
Maximum Eligible Age
17 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Christopher Duggan
OTHER
Sponsor Role
lead
Responsible Party
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Christopher Duggan
MD, MPH
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Christopher Duggan, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Alexandra Carey, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Site Status
Countries
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United States
References
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Other Identifiers
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IRB-P00014026
Identifier Type: -
Identifier Source: org_study_id