- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02561819
Measurement of Body Composition by Air Displacement Plethysmography in Pediatric Intestinal Failure Patients
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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Single Visit
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher Duggan, MD, MPH, Boston Children's Hospital
- Principal Investigator: Alexandra Carey, MD, Boston Children's Hospital
Publications and helpful links
General Publications
- Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
- Burnham JM, Shults J, Semeao E, Foster BJ, Zemel BS, Stallings VA, Leonard MB. Body-composition alterations consistent with cachexia in children and young adults with Crohn disease. Am J Clin Nutr. 2005 Aug;82(2):413-20. doi: 10.1093/ajcn.82.2.413.
- Squires RH, Duggan C, Teitelbaum DH, Wales PW, Balint J, Venick R, Rhee S, Sudan D, Mercer D, Martinez JA, Carter BA, Soden J, Horslen S, Rudolph JA, Kocoshis S, Superina R, Lawlor S, Haller T, Kurs-Lasky M, Belle SH; Pediatric Intestinal Failure Consortium. Natural history of pediatric intestinal failure: initial report from the Pediatric Intestinal Failure Consortium. J Pediatr. 2012 Oct;161(4):723-8.e2. doi: 10.1016/j.jpeds.2012.03.062. Epub 2012 May 11.
- Gosselin KB, Duggan C. Enteral nutrition in the management of pediatric intestinal failure. J Pediatr. 2014 Dec;165(6):1085-90. doi: 10.1016/j.jpeds.2014.08.012. Epub 2014 Sep 18. No abstract available.
- O'Keefe SJ, Buchman AL, Fishbein TM, Jeejeebhoy KN, Jeppesen PB, Shaffer J. Short bowel syndrome and intestinal failure: consensus definitions and overview. Clin Gastroenterol Hepatol. 2006 Jan;4(1):6-10. doi: 10.1016/j.cgh.2005.10.002.
- Winkler MF, Smith CE. Clinical, social, and economic impacts of home parenteral nutrition dependence in short bowel syndrome. JPEN J Parenter Enteral Nutr. 2014 May;38(1 Suppl):32S-37S. doi: 10.1177/0148607113517717. Epub 2014 Jan 13.
- Sharma TS, Bechard LJ, Feldman HA, Venick R, Gura K, Gordon CM, Sonis A, Guinan EC, Duggan C. Effect of titrated parenteral nutrition on body composition after allogeneic hematopoietic stem cell transplantation in children: a double-blind, randomized, multicenter trial. Am J Clin Nutr. 2012 Feb;95(2):342-51. doi: 10.3945/ajcn.111.026005. Epub 2011 Dec 28.
- Murphy AJ, Wells JC, Williams JE, Fewtrell MS, Davies PS, Webb DK. Body composition in children in remission from acute lymphoblastic leukemia. Am J Clin Nutr. 2006 Jan;83(1):70-4. doi: 10.1093/ajcn/83.1.70.
- Stallings VA, Tomezsko JL, Schall JI, Mascarenhas MR, Stettler N, Scanlin TF, Zemel BS. Adolescent development and energy expenditure in females with cystic fibrosis. Clin Nutr. 2005 Oct;24(5):737-45. doi: 10.1016/j.clnu.2005.02.005. Epub 2005 Apr 8.
- Farrell AG, Schamberger MS, Olson IL, Leitch CA. Large left-to-right shunts and congestive heart failure increase total energy expenditure in infants with ventricular septal defect. Am J Cardiol. 2001 May 1;87(9):1128-31, A10. doi: 10.1016/s0002-9149(01)01479-5. No abstract available.
- Ellis KJ, Shypailo RJ, Wong WW. Measurement of body water by multifrequency bioelectrical impedance spectroscopy in a multiethnic pediatric population. Am J Clin Nutr. 1999 Nov;70(5):847-53. doi: 10.1093/ajcn/70.5.847. Erratum In: Am J Clin Nutr 2000 Jun;71(6):1618.
- Elberg J, McDuffie JR, Sebring NG, Salaita C, Keil M, Robotham D, Reynolds JC, Yanovski JA. Comparison of methods to assess change in children's body composition. Am J Clin Nutr. 2004 Jul;80(1):64-9. doi: 10.1093/ajcn/80.1.64.
- Ginde SR, Geliebter A, Rubiano F, Silva AM, Wang J, Heshka S, Heymsfield SB. Air displacement plethysmography: validation in overweight and obese subjects. Obes Res. 2005 Jul;13(7):1232-7. doi: 10.1038/oby.2005.146.
- Gately PJ, Radley D, Cooke CB, Carroll S, Oldroyd B, Truscott JG, Coward WA, Wright A. Comparison of body composition methods in overweight and obese children. J Appl Physiol (1985). 2003 Nov;95(5):2039-46. doi: 10.1152/japplphysiol.00377.2003.
- Schoeller DA, van Santen E, Peterson DW, Dietz W, Jaspan J, Klein PD. Total body water measurement in humans with 18O and 2H labeled water. Am J Clin Nutr. 1980 Dec;33(12):2686-93. doi: 10.1093/ajcn/33.12.2686.
- Van Kreel BK, Van der Vegt F, Meers M, Wagenmakers T, Westerterp K, Coward A. Determination of total body water by a simple and rapid mass spectrometric method. J Mass Spectrom. 1996 Jan;31(1):108-11. doi: 10.1002/(SICI)1096-9888(199601)31:13.0.CO;2-M.
- Wong WW, Cochran WJ, Klish WJ, Smith EO, Lee LS, Klein PD. In vivo isotope-fractionation factors and the measurement of deuterium- and oxygen-18-dilution spaces from plasma, urine, saliva, respiratory water vapor, and carbon dioxide. Am J Clin Nutr. 1988 Jan;47(1):1-6. doi: 10.1093/ajcn/47.1.1.
- Andersen GS, Girma T, Wells JC, Kaestel P, Leventi M, Hother AL, Michaelsen KF, Friis H. Body composition from birth to 6 mo of age in Ethiopian infants: reference data obtained by air-displacement plethysmography. Am J Clin Nutr. 2013 Oct;98(4):885-94. doi: 10.3945/ajcn.113.063032. Epub 2013 Aug 28.
- Plasqui G, Soenen S, Westerterp-Plantenga MS, Westerterp KR. Measurement of longitudinal changes in body composition during weight loss and maintenance in overweight and obese subjects using air-displacement plethysmography in comparison with the deuterium dilution technique. Int J Obes (Lond). 2011 Aug;35(8):1124-30. doi: 10.1038/ijo.2010.250. Epub 2010 Nov 23.
- Rosendale RP, Bartok CJ. Air-displacement plethysmography for the measurement of body composition in children aged 6-48 months. Pediatr Res. 2012 Mar;71(3):299-304. doi: 10.1038/pr.2011.42. Epub 2012 Jan 18.
- Prior BM, Cureton KJ, Modlesky CM, Evans EM, Sloniger MA, Saunders M, Lewis RD. In vivo validation of whole body composition estimates from dual-energy X-ray absorptiometry. J Appl Physiol (1985). 1997 Aug;83(2):623-30. doi: 10.1152/jappl.1997.83.2.623.
- Buchholz AC, Bartok C, Schoeller DA. The validity of bioelectrical impedance models in clinical populations. Nutr Clin Pract. 2004 Oct;19(5):433-46. doi: 10.1177/0115426504019005433.
- Bunt JC, Lohman TG, Boileau RA. Impact of total body water fluctuations on estimation of body fat from body density. Med Sci Sports Exerc. 1989 Feb;21(1):96-100. doi: 10.1249/00005768-198902000-00017.
- Mehta NM, Raphael B, Guteirrez IM, Quinn N, Mitchell PD, Litman HJ, Jaksic T, Duggan CP. Comparison of body composition assessment methods in pediatric intestinal failure. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):99-105. doi: 10.1097/MPG.0000000000000364.
- Zemel BS, Riley EM, Stallings VA. Evaluation of methodology for nutritional assessment in children: anthropometry, body composition, and energy expenditure. Annu Rev Nutr. 1997;17:211-35. doi: 10.1146/annurev.nutr.17.1.211.
- Pichler J, Chomtho S, Fewtrell M, Macdonald S, Hill SM. Growth and bone health in pediatric intestinal failure patients receiving long-term parenteral nutrition. Am J Clin Nutr. 2013 Jun;97(6):1260-9. doi: 10.3945/ajcn.112.057935. Epub 2013 Apr 10.
- Goulet O, Baglin-Gobet S, Talbotec C, Fourcade L, Colomb V, Sauvat F, Jais JP, Michel JL, Jan D, Ricour C. Outcome and long-term growth after extensive small bowel resection in the neonatal period: a survey of 87 children. Eur J Pediatr Surg. 2005 Apr;15(2):95-101. doi: 10.1055/s-2004-821214.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-P00014026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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