Nephronic Reduction After Neonatal Acute Renal Failure in Preterm (IRENEO)

October 15, 2014 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44093
        • CHU of Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of blood pressure
Time Frame: Day 1 (at inclusion)
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
Time Frame: day 1
day 1
creatinine clearance
Time Frame: day 1
day 1
calciuria
Time Frame: Day 1
Day 1
sodium clearance
Time Frame: day 1
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Emma ALLAIN-LAUNAY, PH, CHU de Nantes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

January 18, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Estimate)

October 16, 2014

Last Update Submitted That Met QC Criteria

October 15, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC12_0238

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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