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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02743273

Enrollment

Registered

2016-04-19

Start date

2015-10-31

Completion date

2017-11-30

Last updated

2018-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 3 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
change the level of novel urinary biomarkers after ibuprofen administration	change from 1 day before ibuprofen administration to 1 day after ibuprofen administration

Secondary

Measure	Time frame
The level of novel urinary biomarkers in initial urine	within 24 hours after birth

Countries

South Korea

Outcome results