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NCT02813109 Clinical Trial

Urine Biomarkers for Renal Function Monitoring in Preterm Infants

Premature Infant Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02813109
Other study ID # U-BIO-16
Secondary ID
Status Completed
Phase N/A
First received June 20, 2016
Last updated April 27, 2017
Start date June 2016
Est. completion date March 2, 2017

Study information
Verified date April 2017
Source Inha University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 83
Est. completion date March 2, 2017
Est. primary completion date February 15, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 2 Weeks
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Inha University Hospital Incheon
Korea, Republic of Hallym University Medical Center - Kangnam Seoul

Sponsors (2)
Lead Sponsor Collaborator
Inha University Hospital Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine postnatal 1day
Primary correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine postnatal 3day
Primary correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine postnatal 5day
Primary correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine postnatal 7day
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