Clinical trial NCT02375854: Outcomes of Neonatal Acute Kidney Injury In Premature Infants
Official title: Outcomes of Neonatal Acute Kidney Injury and Prematurity: An Observational Study and Einstein-Montefiore Neonatal Acute Kidney Injury Clinical Registry and Biorepository
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Chronic Kidney Disease
Keywords: preterm
acute kidney injury
biomarkers
chronic kidney disease
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm infants less than 32 weeks' gestational age

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.

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

Primary outcomes:
measure: Chronic kidney disease (incidence of chronic renal insufficiency in childhood)
timeFrame: 5 years
Secondary outcomes:
measure: Acute kidney injury (incidence of acute kidney injury in preterm infants)
timeFrame: 0-5 months
measure: Assessment of serum biomarkers - cystatin C
timeFrame: 0 months - 5 years
measure: Assessment of urinary biomarkers - urinary neutrophil gelatinase-associated lipocalin, interlukin 18 and kidney-injury molecule-1
timeFrame: 0 months - 5 years
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jack D. Weiler Hospital
state: New York
Study officials:
affiliation: The Children's Hospital at Montefiore, Albert Einstein College of Medicine
name: Mamta Fuloria, MD
role: PRINCIPAL_INVESTIGATOR
References: