Outcomes of Neonatal Acute Kidney Injury In Premature Infants

Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Hospital
Therapuetic Areas:Nephrology / Urology, Other
Age Range:Any - 5
Start Date:November 2014
End Date:December 2025
Contact:Mamta Fuloria, MD

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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

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.

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.

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
We found this trial at
Bronx, New York
Phone: 718-904-4105
Bronx, NY
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