Nephronic Reduction After Neonatal Acute Renal Failure in Preterm

Neonatal Acute Renal Failure in Preterm Clinical Trial

— IRENEO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785238
• Other study ID #: RC12_0238
• Status: Completed
• Phase: N/A
• First received: January 18, 2013
• Last updated: October 15, 2014
• Start date: February 2013
• Est. completion date: October 2013

Study information

• Verified date: October 2014
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France:ANSM
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 10 Years

Eligibility

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

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Kidney Injury
• Neonatal Acute Renal Failure in Preterm
• Premature Birth
• Renal Insufficiency

Intervention

Other:
• renal echography
renal echography to analyse the kidney
• Blood sampling
Blood sampling to analyse different parameters of renal function
• collection of an urine sample
Collection of an urine sample to perform analysis of renal function parameters
• Blood pressure measurement

Locations

Country	Name	City	State
France	CHU of Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 (at inclusion)	No
Secondary	measurement of blood pressure	Evaluation of other renal parameters: blood pressure, renal filtration, tubular functions evaluation of renal size and differentiation by ultrasound	Day 1 (at inclusion)	No
Secondary	measurement of length and volume of kidney by renal echography		day 1	No
Secondary	creatinine clearance		day 1	No
Secondary	calciuria		Day 1	No
Secondary	sodium clearance		day 1	No