Neonatal Kidney Health Follow-Up Program

M
Michelle C. Starr, MD

Primary Investigator

Overview

The goal of the program is to systematically follow neonatal patients with acute kidney injury (AKI) and identify both short and long-term outcomes. This follow-up research project will be in concert with ongoing clinical care in the Neonatal Kidney Health Follow-Up Program. 
•    Systematically and prospectively document the incidence of chronic kidney disease (CKD) in the neonatal population following an episode acute kidney injury (AKI) episode and identify short and long-term outcomes.
•    Develop a predictive model of developing chronic kidney disease after an episode of acute kidney injury, predicting that neonates with more sever forms of pediatric AKI will be more likely to develop CKD

Description

-The study team will collect any left-over urine that participants give for their doctor. We will use this urine to perform the urinary biomarker research tests. If there is no left-over urine, we will ask the participant to give us a urine sample. This will take 5-10 minutes. Urinary biomarkers available at time of each visit (5-10ml) to be processed and analyzed in the Nephrology Biomarker Lab at CCHMC.

-The study team will collect data from the participant's medical record for information related to the AKI diagnosis.

Eligibility

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

  • Conditions:
    acute kidney injury,AKI
  • Age: Between 1 Minutes - 2 Months
  • Gender: All

•We will approach and recruit all NICU patients with Stage 2 or Stage 3 Acute Kidney Injury at Riley Hospital for Children Downtown to participate in this follow-up study, and the follow-up program.
•We will approach all patients for participation that are admitted to the Neonatal ICU with any specific cause of AKI (with the exceptions per the exclusion criteria) who meets Kidney Disease Improving Global Outcomes (KDIGO) stage 2 or 3 criteria for at least 48 hours. 

As part of ongoing care in the Riley Hospital for Children Downtown NICU, Dr. Starr (Study PI) or another Pediatric Nephrology provider will round with the Neonatology team as part of “Neonatal Nephrology” rounds. Patients identified as part of this clinical care will be referred for ongoing clinical care as part of the Neonatal Kidney Health Follow-Up Program. Of note, participation in this study is independent from the clinical care provided as part of the Neonatal Kidney Health Follow-Up Program, and families that chose not to participate in this research project will still be cared for in the follow-up program. The decision to enroll or not enroll in this study will not impact clinical care either in the NICU or after discharge.
 
4.2    Exclusion Criteria
List the criteria:
•We will exclude infants who do not have any data available regarding AKI (no serum creatinine available and/or no urine output data available.)
•We will exclude infants admitted after 14 days of age, those transferred to other hospitals within 2 days of admission, infants with severe congenital renal abnormalities, such as congenital abnormalities of the kidney and urinary tract, as judged by the study investigators.
•    We will exclude infants who are not expected to survive hospitalization.

Updated on 27 Nov 2023. Study ID: 2002195483

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