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

NCT02743273 | Completed DMC

• 1 other identifier: 1507-028-686
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• change the level of novel urinary biomarkers after ibuprofen administration

  change from 1 day before ibuprofen administration to 1 day after ibuprofen administration

Secondary Outcomes (1)

• The level of novel urinary biomarkers in initial urine

  within 24 hours after birth

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

1. Preterm infants with gestational age\<32 weeks or birth weight\<1,500 g who enrolled our institutional prospective cohort study for biorepository. 2. Preterm infants with gestational age\<32 weeks or birth weight\< 1,500 g who need ibuprofen treatment for closing patent ductus arteriosus.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Children's Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Han-Suk Kim, MD, PhD.

  Seoul National University Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Neonatal Intensive Care Unit

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: April 19, 2016
• Study Start: October 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: November 1, 2017
• Last Updated: July 20, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)