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Clinical Trials/NCT01785238
NCT01785238
Completed
Not Applicable

Renal Prognosis of Former Preterm Infants 3 to 10 Years After Neonatal Acute Renal Failure

Nantes University Hospital1 site in 1 country75 target enrollmentFebruary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neonatal Acute Renal Failure in Preterm
Sponsor
Nantes University Hospital
Enrollment
75
Locations
1
Primary Endpoint
microalbuminuria
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The aim of this study is to evaluate the signs of nephronic reduction in preterm infants who have presented neonatal acute renal failure. The investigators hypothesize that signs of nephronic reduction would appear earlier in former preterm with neonatal acute renal failure than in control preterm infants.

Detailed Description

50 former preterm infants who presented acute renal failure will be evaluated between 3 to 10 years. They will be compared to 25 control former preterm infants without renal dysfunction for signs of nephronic reduction. At inclusion, in order to analyse renal function, all infants will have blood sampling, renal echography and blood pressure measurement. Urine sample will also be collected. Two months later, parents will be informed on the results.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
October 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • For both group of cases (50 infants having presented acute renal failure in preterm) AND group of control cases (25 infants without this) :former preterm infant born before 33 weeks of gestational age between january 2003 and june 2010 and hospitalized in the neonatal intensive care unit of Nantes University Hospital.
  • Specific to cases: neonatal acute renal failure: serum creatinine\>130 micromol/l from the third day of life.
  • Control cases: no such renal dysfunction

Exclusion Criteria

  • no parental consent
  • other causes of renal failure: congenital uropathy, congenital nephropathy
  • congenital cardiopathy, polymalformative syndrome

Outcomes

Primary Outcomes

microalbuminuria

Time Frame: Day 1 (at inclusion)

The primary outcome of this study is to prove that former preterm infants with neonatal acute renal failure are at higher risk of nephronic reduction than control former preterm infants and that they will present microalbuminuria as earlier sign of nephronic reduction. Precisely, if microalbuminuria divided by creatinuria is above 20mg/g or 2mg/mmol, it will be considered as pathologic.

Secondary Outcomes

  • measurement of length and volume of kidney by renal echography(day 1)
  • creatinine clearance(day 1)
  • measurement of blood pressure(Day 1 (at inclusion))
  • sodium clearance(day 1)
  • calciuria(Day 1)

Study Sites (1)

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