Urine Biomarkers for Renal Function Monitoring in Preterm Infants

April 27, 2017 updated by: Juyoung Lee, Inha University Hospital
The true renal function of preterm infants is difficult to evaluate. Serum creatinine (Cr) levels in infants are unreliable as a detector of renal function in the first few days of life because they may continue to reflect maternal levels. Although few candidates appear to be a useful biomarker for kidney injury, scant reference data on these biomarker in preterm infants exist, and studies have yielded conflicting results. Therefore, we aimed to determine the reliable urinary biomarkers to detect kidney injuries in preterm infants.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Seoul, Korea, Republic of
        • Hallym University Medical Center - Kangnam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

below gestational age 37 weeks

Description

Inclusion Criteria:

  • premature infants born before 37 weeks of gestational age

Exclusion Criteria:

  • cardiac or renal anomalies
  • transferred in 2 days after birth from other hospitals

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine
Time Frame: postnatal 1day
postnatal 1day
correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine
Time Frame: postnatal 3day
postnatal 3day
correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine
Time Frame: postnatal 5day
postnatal 5day
correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine
Time Frame: postnatal 7day
postnatal 7day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inha University Hospital

Collaborators

Hallym University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

February 15, 2017

Study Completion (Actual)

March 2, 2017

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 24, 2016

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

April 27, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • U-BIO-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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