Nephronic Reduction After Neonatal Acute Renal Failure in Preterm

NCT ID: NCT01785238

Last Updated: 2014-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-10-31

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.

Conditions

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Neonatal Acute Renal Failure in Preterm

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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cases with neonatal acute renal failure in preterm

Group Type EXPERIMENTAL

renal echography

Intervention Type OTHER

renal echography to analyse the kidney

Blood sampling

Intervention Type OTHER

Blood sampling to analyse different parameters of renal function

collection of an urine sample

Intervention Type OTHER

Collection of an urine sample to perform analysis of renal function parameters

Blood pressure measurement

Intervention Type OTHER

controls without neonatal acute renal failure in preterm

Group Type OTHER

renal echography

Intervention Type OTHER

renal echography to analyse the kidney

Blood sampling

Intervention Type OTHER

Blood sampling to analyse different parameters of renal function

collection of an urine sample

Intervention Type OTHER

Collection of an urine sample to perform analysis of renal function parameters

Blood pressure measurement

Intervention Type OTHER

Interventions

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renal echography

renal echography to analyse the kidney

Intervention Type OTHER

Blood sampling

Blood sampling to analyse different parameters of renal function

Intervention Type OTHER

collection of an urine sample

Collection of an urine sample to perform analysis of renal function parameters

Intervention Type OTHER

Blood pressure measurement

Intervention Type OTHER

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
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emma ALLAIN-LAUNAY, PH

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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CHU of Nantes

Nantes, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 27335060 (View on PubMed)

Other Identifiers

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RC12_0238

Identifier Type: -

Identifier Source: org_study_id

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