Nephronic Reduction After Neonatal Acute Renal Failure in Preterm

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neonatal Acute Renal Failure in Preterm

Intervention / Treatment
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* Other: renal echography
* Other: Blood sampling
* Other: collection of an urine sample
* Other: Blood pressure measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cases with neonatal acute renal failure in preterm<br> | Other: renal echography<br>* renal echography to analyse the kidney<br>Other: Blood sampling<br>* Blood sampling to analyse different parameters of renal function<br>Other: collection of an urine sample<br>* Collection of an urine sample to perform analysis of renal function parameters<br>Other: Blood pressure measurement<br> <br> |
| Other: controls without neonatal acute renal failure in preterm<br> | Other: renal echography<br>* renal echography to analyse the kidney<br>Other: Blood sampling<br>* Blood sampling to analyse different parameters of renal function<br>Other: collection of an urine sample<br>* Collection of an urine sample to perform analysis of renal function parameters<br>Other: Blood pressure measurement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microalbuminuria | 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. | Day 1 (at inclusion) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm infants, acute renal failure, nephronic reduction