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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02743273
• Other study ID #: 1507-028-686
• Status: Completed
• Start date: October 2015
• Est. completion date: November 2017

Study information

• Verified date: July 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Children's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change the level of novel urinary biomarkers after ibuprofen administration		change from 1 day before ibuprofen administration to 1 day after ibuprofen administration
Secondary	The level of novel urinary biomarkers in initial urine		within 24 hours after birth