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Completed

NCT Number: NCT01785238

Nephronic Reduction After Neonatal Acute Renal Failure in Preterm

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.

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Key information

Conditions

Neonatal Acute Renal Failure in Preterm Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU of Nantes

Nantes, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

renal echography

Other

renal echography to analyse the kidney

Blood sampling

Other

Blood sampling to analyse different parameters of renal function

collection of an urine sample

Other

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

Blood pressure measurement

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. measurement of length and volume of kidney by renal echography

    Time frame: day 1

  3. creatinine clearance

    Time frame: day 1

  4. calciuria

    Time frame: Day 1

  5. sodium clearance

    Time frame: day 1

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: IRENEO

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 7, 2013
Registry last updated
Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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