Measurement of Body Composition by Air Displacement Plethysmography in Pediatric Intestinal Failure Patients

NCT02561819 | Completed

• 1 other identifier: IRB-P00014026
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Short Bowel Syndrome

Keywords

Short Bowel Syndrome; Congenital Short Bowel Syndrome; Body Composition; Parenteral Nutrition; Intestinal Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Single Visit

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with intestinal failure between 2-17 years of age inclusive will be recruited through the Center for Advanced Intestinal Rehabilitation (CAIR) program at Boston Children's Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christopher Duggan: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (27)

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Biospecimen

Retention: SAMPLES WITH DNA

Urine samples

MeSH Terms

Conditions

Short Bowel Syndrome; Intestinal Pseudo-Obstruction; Hyperphagia; Intestinal Failure

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ileus; Intestinal Obstruction; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Christopher Duggan, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Alexandra Carey, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, MPH

Study Record Dates

• First Submitted: September 25, 2015
• First Posted: September 28, 2015
• Study Start: November 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: December 1, 2020
• Last Updated: December 16, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)