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Urine Biomarkers for Renal Function Monitoring in Preterm Infants

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ClinicalTrials.gov Identifier: NCT02813109
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
Hallym University Medical Center
Information provided by (Responsible Party):
Juyoung Lee, Inha University Hospital

Tracking Information
First Submitted Date June 20, 2016
First Posted Date June 24, 2016
Last Update Posted Date April 28, 2017
Study Start Date June 2016
Actual Primary Completion Date February 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 21, 2016)
  • correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine [ Time Frame: postnatal 1day ]
  • correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine [ Time Frame: postnatal 3day ]
  • correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine [ Time Frame: postnatal 5day ]
  • correlation of urinary NGAL (neutrophil-gelatinase-associated lipocalin) with serum creatinine [ Time Frame: postnatal 7day ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Urine Biomarkers for Renal Function Monitoring in Preterm Infants
Official Title Not Provided
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
urine
Sampling Method Non-Probability Sample
Study Population below gestational age 37 weeks
Condition Premature Infant
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 27, 2017)
83
Original Estimated Enrollment
 (submitted: June 21, 2016)
120
Actual Study Completion Date March 2, 2017
Actual Primary Completion Date February 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 2 Weeks   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02813109
Other Study ID Numbers U-BIO-16
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Juyoung Lee, Inha University Hospital
Study Sponsor Inha University Hospital
Collaborators Hallym University Medical Center
Investigators Not Provided
PRS Account Inha University Hospital
Verification Date April 2017