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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02743273
Collaborator
(none)
37
Enrollment
1
Location
25
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    37 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Identification of Prognostic Urinary Biomarker for Acute Kidney Injury in Preterm Infants by Proteomics
    Study Start Date :
    Oct 1, 2015
    Actual Primary Completion Date :
    Aug 1, 2016
    Actual Study Completion Date :
    Nov 1, 2017

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    1. The level of novel urinary biomarkers in initial urine [within 24 hours after birth]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 3 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Children's Hospital Seoul Korea, Republic of 110-744

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Han-Suk Kim, MD, PhD., Seoul National University Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Han-Suk Kim, Professor, Director of Neonatal Intensive Care Unit, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02743273
    Other Study ID Numbers:
    • 1507-028-686
    First Posted:
    Apr 19, 2016
    Last Update Posted:
    Jul 20, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Acute Kidney Injury
    Wounds and Injuries

    Study Results

    No Results Posted as of Jul 20, 2018