Identification of Prognostic Urinary Biomarker for Acute Kidney Injury in Preterm Infants by Proteomics

Completed

• Conditions: Acute Kidney Injury

• Registration Number: NCT02743273
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Clinical definitions of acute kidney injury (AKI) have been based on an increase in serum creatinine and a decrease in urine output. However, applying this definition to neonates remains challenging because of the normal renal physiologic features that serum creatinine levels are expected to increase in the first days after birth, and impaired sodium reabsorption and concentrating ability.

Because of several limitations of early detection of AKI, investigators are focused on identifying biomarkers that predict AKI before an increase serum creatinine level.

Investigators will collect urine from preterm infants before and after administrating ibuprofen for closing patent ductus arteriosus. To identify novel biomarkers, investigators will analyze urine by proteomics. To verify those biomarkers, investigators will use initial urine on the first day of life from preterm infants who diagnosed AKI within 7 days after birth without any risk factors for AKI and enrolled institutional bio-repository.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-12-09
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-19
• Primary Completion: 2016-08
• Study Completion: 2017-11
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-18
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Preterm infants less than 32 weeks gestational age or birth weight less than 1,500 g admitted to the neonatal intensive care unit at Seoul National University Children's hospital

Exclusion Criteria

• Congenital heart disease
• Known major congenital anomalies of the kidney and urinary tract
• Other genetic syndromes or medical conditions that preclude enrollment per judgement of the attending neonatologist

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change the level of novel urinary biomarkers after ibuprofen administration	change from 1 day before ibuprofen administration to 1 day after ibuprofen administration

Secondary Outcome Measures

Name	Time	Method
The level of novel urinary biomarkers in initial urine	within 24 hours after birth

Trial Locations

Locations (1)

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of