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

NCT ID: NCT02743273

Last Updated: 2018-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-11-30

Brief Summary

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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

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Conditions

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Acute Kidney Injury

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Han-Suk Kim

Professor, Director of Neonatal Intensive Care Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Han-Suk Kim, MD, PhD.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Children's Hospital

Locations

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Seoul National University Children's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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1507-028-686

Identifier Type: -

Identifier Source: org_study_id

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