Evaluation of the Effect of Acute Kidney Injury on Body Composition Among Preterm Infants. A Prospective Case-Control Observational Pilot Study
Studying Body Composition in Preterm Infants with Kidney Issues
Brianna Liberio
Primary Investigator
Brief description of study
The purpose of this study is to assess the body composition and growth measurements at time of NICU discharge of preterm infants who experienced acute kidney injury during their hospitalization, and to compare this with matched controls who did not experience acute kidney injury.
Detailed description of study
This pilot study is a prospective, observational, matched case-control study, using data from retrospective chart review and a prospectively-collected database. Research procedures will take place in the Riley Maternity Tower NICU at Riley Hospital, as well as IU school of medicine offices on the IU campus.
Study Intervention
Air displacement plethysmography
o This study will utilize the PEA POD (COSMED), which is an air displacement plethysmography system using whole body densitometry to determine body composition. The PEA POD is a Food and Drug Administration (FDA)-approved medical device that is widely used in medical research as well as clinical settings in NICUs across the world.
o Following the consent process, research staff will discuss the ability and safety of the infant to undergo body composition assessment with the medical team. At the approval of the supervising physician, the infant will undergo body composition assessment by ADP using the PEA POD at the appropriate time per study calendar/timeline.
o Each subject will be transported to the Riley Maternity Tower NICU research room, where the PEA POD machine is located. Each subject will be on continuous cardiorespiratory transport monitors during this transport time. Each subject will be weighed on the PEA POD’s scale and then placed in warmed chamber for ADP measurements. Each subject will be observed during the measurement time period by the research NICU nurse, and each subject will be able to be seen through a clear window in the chamber. While all steps take ~7 minutes, the measurements take ~2 minutes. This measurement process will occur up to two times, to account for any errors or technical difficulties encountered.
o 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.
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Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Acute Kidney Injury, AKI, Riley
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Age: 32 weeks or below
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Gender: All
Inclusion Criteria
• Preterm infants • Admitted to the Riley Hospital Maternity Tower NICU within the first week of life
• Patient and parent/caregiver available to be approached at least 2 weeks prior to discharge
• Expected to be without any respiratory support at time of ADP measurement.
Exclusion Criteria for both groups
• Infants with an underlying genetic diagnosis that could alter growth trajectory
• Infants with major congenital malformations (including congenital anomalies of the kidneys or urinary tract)
• Infants requiring a major surgical procedure during NICU hospitalization
• Infants weighing > 8 kg at time of discharge
This study investigates the body composition of preterm infants who have experienced acute kidney injury. The purpose is to compare the growth and body composition of these infants at the time of NICU discharge to those who did not have acute kidney injury. Acute kidney injury is a condition where the kidneys suddenly cannot filter waste from the blood as well as they normally do, which can affect overall health.
During the study, infants will undergo a procedure called air displacement plethysmography (ADP) using a machine called the PEA POD. This device measures body composition, including fat mass and fat-free mass. The procedure involves placing the infant in a special chamber for a few minutes to get accurate readings. The infants' safety and comfort are prioritized, and the process is closely monitored by medical staff.
- Who can participate: Preterm infants admitted to the Riley Hospital Maternity Tower NICU within the first week of life can participate. Parents or caregivers must be available for consent at least 2 weeks before discharge. Infants should not need respiratory support at the time of measurement.
- Study details: Participants will undergo body composition measurements using the PEA POD device, which involves a short procedure in a special chamber. This is an observational study, meaning no changes will be made to the infants' treatment.
