Nephronic Reduction After Neonatal Acute Renal Failure in Preterm

Not Applicable

Completed

• Conditions: Neonatal Acute Renal Failure in Preterm
• Interventions: Other: renal echography; Other: Blood sampling; Other: collection of an urine sample; Other: Blood pressure measurement

• Registration Number: NCT01785238
• Lead Sponsor: Nantes University Hospital

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.

Study Timeline

• Study First Submitted: 2013-01-18
• Study Start: 2013-02
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-07
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-15
• Last Update Posted: 2014-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cases with neonatal acute renal failure in preterm	Blood pressure measurement	-
controls without neonatal acute renal failure in preterm	renal echography	-
cases with neonatal acute renal failure in preterm	collection of an urine sample	-
controls without neonatal acute renal failure in preterm	Blood sampling	-
controls without neonatal acute renal failure in preterm	collection of an urine sample	-
cases with neonatal acute renal failure in preterm	Blood sampling	-
controls without neonatal acute renal failure in preterm	Blood pressure measurement	-
cases with neonatal acute renal failure in preterm	renal echography	-

Primary Outcome Measures

Name	Time	Method
microalbuminuria	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 Outcome Measures

Name	Time	Method
measurement of length and volume of kidney by renal echography	day 1
creatinine clearance	day 1
measurement of blood pressure	Day 1 (at inclusion)	Evaluation of other renal parameters: blood pressure, renal filtration, tubular functions evaluation of renal size and differentiation by ultrasound
sodium clearance	day 1
calciuria	Day 1

Trial Locations

Locations (1)

CHU of Nantes; 🇫🇷 Nantes, France