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

Primary Purpose

Neonatal Acute Renal Failure in Preterm

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
renal echography
Blood sampling
collection of an urine sample
Blood pressure measurement
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Neonatal Acute Renal Failure in Preterm focused on measuring preterm infants, acute renal failure, nephronic reduction

Eligibility Criteria

3 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU of Nantes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

cases with neonatal acute renal failure in preterm

controls without neonatal acute renal failure in preterm

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

measurement of blood pressure
Evaluation of other renal parameters: blood pressure, renal filtration, tubular functions evaluation of renal size and differentiation by ultrasound
measurement of length and volume of kidney by renal echography
creatinine clearance
calciuria
sodium clearance

Full Information

First Posted
January 18, 2013
Last Updated
October 15, 2014
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01785238
Brief Title
Nephronic Reduction After Neonatal Acute Renal Failure in Preterm
Acronym
IRENEO
Official Title
Renal Prognosis of Former Preterm Infants 3 to 10 Years After Neonatal Acute Renal Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Acute Renal Failure in Preterm
Keywords
preterm infants, acute renal failure, nephronic reduction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cases with neonatal acute renal failure in preterm
Arm Type
Experimental
Arm Title
controls without neonatal acute renal failure in preterm
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
renal echography
Intervention Description
renal echography to analyse the kidney
Intervention Type
Other
Intervention Name(s)
Blood sampling
Intervention Description
Blood sampling to analyse different parameters of renal function
Intervention Type
Other
Intervention Name(s)
collection of an urine sample
Intervention Description
Collection of an urine sample to perform analysis of renal function parameters
Intervention Type
Other
Intervention Name(s)
Blood pressure measurement
Primary Outcome Measure Information:
Title
microalbuminuria
Description
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.
Time Frame
Day 1 (at inclusion)
Secondary Outcome Measure Information:
Title
measurement of blood pressure
Description
Evaluation of other renal parameters: blood pressure, renal filtration, tubular functions evaluation of renal size and differentiation by ultrasound
Time Frame
Day 1 (at inclusion)
Title
measurement of length and volume of kidney by renal echography
Time Frame
day 1
Title
creatinine clearance
Time Frame
day 1
Title
calciuria
Time Frame
Day 1
Title
sodium clearance
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma ALLAIN-LAUNAY, PH
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU of Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27335060
Citation
Bruel A, Roze JC, Quere MP, Flamant C, Boivin M, Roussey-Kesler G, Allain-Launay E. Renal outcome in children born preterm with neonatal acute renal failure: IRENEO-a prospective controlled study. Pediatr Nephrol. 2016 Dec;31(12):2365-2373. doi: 10.1007/s00467-016-3444-z. Epub 2016 Jun 22.
Results Reference
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Nephronic Reduction After Neonatal Acute Renal Failure in Preterm

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