Outcomes of Neonatal Acute Kidney Injury In Premature Infants

Recruiting

• Conditions: Acute Kidney Injury; Chronic Kidney Disease
• Interventions: Other: Observation

• Registration Number: NCT02375854
• Lead Sponsor: Montefiore Medical Center

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-02-19
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-03-03
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-11
• Last Update Posted: 2023-08-15
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preterm infants	Observation	Less than 32 weeks' gestation

Primary Outcome Measures

Name	Time	Method
Chronic kidney disease (incidence of chronic renal insufficiency in childhood)	5 years	Determine the incidence of chronic renal insufficiency in childhood

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Jack D. Weiler Hospital; 🇺🇸 Bronx, New York, United States