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

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ClinicalTrials.gov Identifier: NCT01785238
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : October 16, 2014
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Neonatal Acute Renal Failure in Preterm Other: renal echography Other: Blood sampling Other: collection of an urine sample Other: Blood pressure measurement Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Renal Prognosis of Former Preterm Infants 3 to 10 Years After Neonatal Acute Renal Failure
Study Start Date : February 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

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
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785238


Locations
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France
CHU of Nantes
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Emma ALLAIN-LAUNAY, PH CHU de Nantes

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01785238     History of Changes
Other Study ID Numbers: RC12_0238
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: October 2014
Keywords provided by Nantes University Hospital:
preterm infants
acute renal failure
nephronic reduction
Additional relevant MeSH terms:
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Premature Birth
Renal Insufficiency
Acute Kidney Injury
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Kidney Diseases
Urologic Diseases