Outcomes of Neonatal Acute Kidney Injury In Premature Infants

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease; Acute Kidney Injury
• Intervention / Treatment: Other: Observation

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Mamta Fuloria, MD; Phone Number: 718-904-4105; Email: mfuloria@montefiore.org
• Study Contact Backup: Name: Deborah Campbell, MD; Phone Number: 718-904-4105; Email: dcampbel@montefiore.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Recruiting
      • Jack D. Weiler Hospital
      • Contact: Mamta Fuloria, MD; Phone Number: 718-904-4105; Email: mfuloria@montefiore.org
      • Contact: Deborah Campbell, MD; Phone Number: 718-904-4105; Email: dcampbel@montefiore.org
      • Sub-Investigator: Kimberly Reid, MD
      • Sub-Investigator: Rani Thekumparampil, MD
      • Sub-Investigator: Frederick Kaskel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 5 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Preterm infants less than 32 weeks' gestational age

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preterm infants; Less than 32 weeks' gestation	Other: Observation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Mamta Fuloria, MD, The Children's Hospital at Montefiore, Albert Einstein College of Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 19, 2015
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimated): March 3, 2015

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: biomarkers; chronic kidney disease; acute kidney injury; preterm
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: 2013-2900