Evaluation of Body Composition Among Infants with Ckd and Esrd: A Prospective Pilot Study

Investigating Body Composition in Infants with Chronic Kidney Disease and End-Stage Renal Disease

M
Michelle C. Starr, MD

Primary Investigator

Enrolling By Invitation
12 months or below
All
Phase N/A
25 participants needed
1 Location

Brief description of study

The objectives of this study are to generate evidence that improves the assessment of nutritional status in infants with CKD and ESKD, to differentiate malnutrition from fluid imbalance, and to inform individualized nutritional and medical interventions aimed at optimizing growth and developmental outcomes.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Eligible subjects will be identified through routine clinical care at Riley Hospital for Children by the nephrology, neonatology, and nutrition teams caring for infants with CKD or ESRD. On a weekly basis, research staff will review the inpatient nephrology census with the clinical team to screen infants under 12 months of age against inclusion and exclusion criteria, focusing on those in whom nutritional assessment is clinically challenging or who require dialysis. If an infant is identified as potentially eligible, the primary treating physician will first be approached to confirm that study participation is appropriate and safe; only with physician agreement will the family be contacted.

Detailed description of study

This is a prospective clinical registry that will enroll two different cohorts of children.  This study will utilize the PEA POD (COSMED), which is an FDA-approved device and considered standard of care for body composition assessment in infants (air displacement plethysmography system or ADP).  The PEA POD is a Food and Drug Administration (FDA)-approved medical device that is widely used in clinical settings in NICUs across the world. The PEA POD is operated by trained staff according to device instructions. ADP measurements to be obtained: fat mass, fat-free mass, body fat percentage. The PEA POD generates objective measurements, and thus blinding of the operator for the PEA POD is unnecessary.  Research procedures will take place at Riley Hospital for Children, primarily within the NICU and a designated locked research room in the Riley Maternity Tower NICU where the PEA POD device is housed.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic kidney disease, CKD, End-stage kidney disease, ESKD, Riley
  • Age: 12 months or below
  • Gender: All

Inclusion Criteria
•    Infants (children •    Expected to be without any respiratory support at time of ADP measurement
•    Agreement from treating nephrologist and nutritionist that additional information on growth is needed.

Exclusion Criteria for both groups
•    Infants weighing •    Infants weighing > 8 kg at time of consideration  

This study investigates the body composition of infants with chronic kidney disease (CKD) and end-stage renal disease (ESRD). CKD and ESRD are conditions where the kidneys are damaged and cannot work properly. This study aims to improve how doctors assess nutrition in these infants and help them grow better. The study uses a special device called the PEA POD, which measures body fat and other body parts without any pain.

In this study, infants will have their body composition measured using the PEA POD device. This device uses air to measure fat mass, fat-free mass, and body fat percentage. It is safe and used in hospitals around the world. The measurements are taken by trained staff at Riley Hospital for Children, mainly in the NICU.

  • Who can participate: Infants under 12 months old with chronic kidney disease or end-stage renal disease, weighing between 2.5 kg and 8 kg, can participate. They should not require respiratory support during the measurement.
  • Study details: Participants will have their body composition measured using the PEA POD device, which involves taking measurements of fat mass and body fat percentage. The device is safe and operated by trained staff.
Updated on 24 Feb 2026. Study ID: PNEPH-IIR-29103, 29103
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only