Outcomes of Neonatal Acute Kidney Injury In Premature Infants

Study Overview
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Brief Summary
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The objective of this protocol is to investigate the impact of prematurity, with or without associated acute kidney injury (AKI), on the future risk of chronic kidney disease (CKD) by establishing a patient registry and biorepository. Serum and urine samples will be collected serially from premature infants admitted to the neonatal intensive care unit (NICU) at Albert Einstein College of Medicine/Weiler Hospital and subsequently followed in the NICU follow-up and pediatric nephrology ambulatory subspecialty clinics. The biorepository will be linked to a comprehensive clinical database.

Detailed Description
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This is an observational pilot study to enhance understanding of the pathophysiology and epidemiology associated with effects of AKI in premature infants and the role that neonatal AKI plays in future development of CKD. In eligible preterm infants, blood and urine samples will be collected at pre-specified time points during hospitalization and at outpatient follow-up appointments at 6 months, 1 year, 2 years, and 5 years of age and stored in the biorepository. Blood pressure will be measured and recorded at NICU discharge and at all follow-up visits. A renal ultrasound will be performed to monitor renal growth at 2 and 5 years of age. All data will be entered into a comprehensive clinical database, including laboratory results.

Official Title
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Outcomes of Neonatal Acute Kidney Injury and Prematurity: An Observational Study and Einstein-Montefiore Neonatal Acute Kidney Injury Clinical Registry and Biorepository

Conditions
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Acute Kidney Injury, Chronic Kidney Disease

Intervention / Treatment
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* Other: Observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants less than 32 weeks/ gestational age admitted to the Neonatal Intensive Care Unit at Weiler Hospital (The Children's Hospital at Montefiore). Exclusion Criteria: Known major congenital anomalies of the kidney and urinary tract (CAKUT) including solitary kidney, cystic dysplasia, multicystic dysplastic kidney, renal hypoplasia, obstructive uropathy Other genetic syndromes or medical conditions that preclude enrollment per judgment of the attending neonatologist

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm infants<br>Less than 32 weeks' gestation | Other: Observation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic kidney disease (incidence of chronic renal insufficiency in childhood) | Determine the incidence of chronic renal insufficiency in childhood | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute kidney injury (incidence of acute kidney injury in preterm infants) | Determine the incidence of acute kidney injury in preterm infants | 0-5 months | 
| Assessment of serum biomarkers - cystatin C | Determination of serum and urinary biomarkers to predict the development of acute kidney injury and chronic renal insufficiency | 0 months - 5 years | 
| Assessment of urinary biomarkers - urinary neutrophil gelatinase-associated lipocalin, interlukin 18 and kidney-injury molecule-1 | Determination of serum and urinary biomarkers to predict the development of acute kidney injury and chronic renal insufficiency | 0 months - 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm, acute kidney injury, biomarkers, chronic kidney disease