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Nephronic Reduction After Neonatal Acute Renal Failure in Preterm

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01785238
Acronym
IRENEO
Enrollment
75
Registered
2013-02-07
Start date
2013-02-01
Completion date
2013-10-01
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Acute Renal Failure in Preterm

Keywords

preterm infants, acute renal failure, nephronic reduction

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.

Interventions

renal echography to analyse the kidney

OTHERBlood sampling

Blood sampling to analyse different parameters of renal function

OTHERcollection of an urine sample

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

OTHERBlood pressure measurement

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
microalbuminuriaDay 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

MeasureTime frameDescription
measurement of blood pressureDay 1 (at inclusion)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 echographyday 1
creatinine clearanceday 1
calciuriaDay 1
sodium clearanceday 1

Countries

France

Contacts

PRINCIPAL_INVESTIGATOREmma ALLAIN-LAUNAY, PH

Nantes University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026