Outcomes of Neonatal Acute Kidney Injury In Premature Infants

Chronic Kidney Disease Clinical Trial

Official title:

Outcomes of Neonatal Acute Kidney Injury and Prematurity: An Observational Study and Einstein-Montefiore Neonatal Acute Kidney Injury Clinical Registry and Biorepository

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02375854
• Other study ID #: 2013-2900
• Status: Recruiting
• Start date: November 2014
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: Montefiore Medical Center
• Contact: Mamta Fuloria, MD
• Phone: 718-904-4105
• Email: mfuloria[@]montefiore.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic
• Wounds and Injuries

Intervention

Other:
• Observation

Locations

Country	Name	City	State
United States	Jack D. Weiler Hospital	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic kidney disease (incidence of chronic renal insufficiency in childhood)	Determine the incidence of chronic renal insufficiency in childhood	5 years
Secondary	Acute kidney injury (incidence of acute kidney injury in preterm infants)	Determine the incidence of acute kidney injury in preterm infants	0-5 months
Secondary	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
Secondary	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