An observational study in Acute Kidney Injury, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged Up to 3 Months. Per ClinicalTrials.gov, last updated 2018-07-20.
Sponsored by Seoul National University Hospital · Observational
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's enrollment of 37 is below the median of 150 across 773 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
change the level of novel urinary biomarkers after ibuprofen administration
Time frame: change from 1 day before ibuprofen administration to 1 day after ibuprofen administration
The level of novel urinary biomarkers in initial urine
Time frame: within 24 hours after birth
Plan to share: Yes
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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital