Evaluation of the Effect of Acute Kidney Injury on Body Composition Among Preterm Infants. a Prospective Case-Control Observational Pilot Study

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Brianna Liberio

Principal Investigator

Status: Enrolling By Invitation Ages: 0 Years - 32 Weeks Gender: All Genders Phase: N/A 1 Locations

Brief Description

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY - All patients admitted to the Riley Hospital Maternity Tower NICU from the date of IRB approval will be screened for eligibility. Outborn infants will be included if admitted within the first week of life. On a weekly basis, research staff will review the census at Riley Hospital Maternity Tower NICU to identify patients nearing discharge (~3-4 weeks prior to discharge). Cases and controls will be determined based on protocol criteria. If the infant is determined to meet eligibility criteria for either group, the parent(s)/caregiver(s) will be approached for consent by research staff or one of the investigators approximately 2 weeks prior to anticipated discharge. The study will be discussed, and participation will be offered. 

Detailed Description

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

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 

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.