Acute Kidney Injury, Chronic Kidney Disease
Conditions
Keywords
preterm, acute kidney injury, biomarkers, chronic kidney disease
Brief summary
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
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.
Interventions
OTHERObservation
Sponsors
Montefiore Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 5 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic kidney disease (incidence of chronic renal insufficiency in childhood) | 5 years | Determine the incidence of chronic renal insufficiency in childhood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute kidney injury (incidence of acute kidney injury in preterm infants) | 0-5 months | Determine the incidence of acute kidney injury in preterm infants |
| Assessment of serum biomarkers - cystatin C | 0 months - 5 years | Determination of serum and urinary biomarkers to predict the development of acute kidney injury and chronic renal insufficiency |
| Assessment of urinary biomarkers - urinary neutrophil gelatinase-associated lipocalin, interlukin 18 and kidney-injury molecule-1 | 0 months - 5 years | Determination of serum and urinary biomarkers to predict the development of acute kidney injury and chronic renal insufficiency |
Countries
United States
Outcome results
None listed