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.
Brief Title
Outcomes of Neonatal Acute Kidney Injury In Premature Infants
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.
Completion Date
Completion Date Type
Actual
Conditions
Acute Kidney Injury
Chronic Kidney Disease
Eligibility Criteria
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
* 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
Inclusion Criteria
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).
* Preterm infants less than 32 weeks/ gestational age admitted to the Neonatal Intensive Care Unit at Weiler Hospital (The Children's Hospital at Montefiore).
Gender
All
Gender Based
false
Keywords
preterm
acute kidney injury
biomarkers
chronic kidney disease
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
5 Years
Minimum Age
1 Day
NCT Id
NCT02375854
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2013-2900
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Outcomes of Neonatal Acute Kidney Injury and Prematurity: An Observational Study and Einstein-Montefiore Neonatal Acute Kidney Injury Clinical Registry and Biorepository
Primary Outcomes
Outcome Description
Determine the incidence of chronic renal insufficiency in childhood
Outcome Measure
Chronic kidney disease (incidence of chronic renal insufficiency in childhood)
Outcome Time Frame
5 years
Secondary Outcomes
Outcome Description
Determine the incidence of acute kidney injury in preterm infants
Outcome Time Frame
0-5 months
Outcome Measure
Acute kidney injury (incidence of acute kidney injury in preterm infants)
Outcome Description
Determination of serum and urinary biomarkers to predict the development of acute kidney injury and chronic renal insufficiency
Outcome Time Frame
0 months - 5 years
Outcome Measure
Assessment of serum biomarkers - cystatin C
Outcome Description
Determination of serum and urinary biomarkers to predict the development of acute kidney injury and chronic renal insufficiency
Outcome Time Frame
0 months - 5 years
Outcome Measure
Assessment of urinary biomarkers - urinary neutrophil gelatinase-associated lipocalin, interlukin 18 and kidney-injury molecule-1
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Preterm infants less than 32 weeks' gestational age
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
5
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Mamta Fuloria
Investigator Email
MFULORIA@montefiore.org
Investigator Phone
718-904-2821