Neonatal Acute Renal Failure in PretermIRENEONCT01785238
Nephronic Reduction After Neonatal Acute Renal Failure in Preterm
A study testing renal echography, Blood sampling and collection of an urine sample in people with Neonatal Acute Renal Failure in Preterm, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Neonatal Acute Renal Failure in Preterm
- What is being tested?
- renal echography, Blood sampling and collection of an urine sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- no parental consent
- other causes of renal failure: congenital uropathy, congenital nephropathy
- congenital cardiopathy, polymalformative syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Renal Prognosis of Former Preterm Infants 3 to 10 Years After Neonatal Acute Renal Failure
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.
Read the 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.
- Conditions
- Neonatal Acute Renal Failure in Preterm
- Being tested
- renal echography, Blood sampling, collection of an urine sample, Blood pressure measurement
- Keywords
- preterm infants, acute renal failure, nephronic reduction
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal echographyOther
renal echography to analyse the kidney
Blood samplingOther
Blood sampling to analyse different parameters of renal function
collection of an urine sampleOther
Collection of an urine sample to perform analysis of renal function parameters
Blood pressure measurementOther
| Study group | Role | What they receive |
|---|---|---|
| cases with neonatal acute renal failure in preterm | Experimental | Not described Receives: Other: renal echography; Other: Blood sampling; Other: collection of an urine sample; Other: Blood pressure measurement |
| controls without neonatal acute renal failure in preterm | Other | Not described Receives: Other: renal echography; Other: Blood sampling; Other: collection of an urine sample; Other: Blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (at inclusion)
Secondary outcomes (5)
measurement of blood pressure
Evaluation of other renal parameters: blood pressure, renal filtration, tubular functions evaluation of renal size and differentiation by ultrasound
Measured: Day 1 (at inclusion)
measurement of length and volume of kidney by renal echography
Measured: day 1
creatinine clearance
Measured: day 1
calciuria
Measured: Day 1
sodium clearance
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal Acute Renal Failure in PretermStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emma ALLAIN-LAUNAY, PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785238
- Sponsor's protocol ID
- RC12_0238
- Acronym
- IRENEO
- Status last verified
- Oct 2014
- First submitted
- 18 Jan 2013
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27335060
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Prognosis of Former Preterm Infants 3 to 10 Years After Neonatal Acute Renal Failure
- ClinicalTrials.gov ID
- NCT01785238
- Acronym / sponsor ID
- IRENEO / RC12_0238
- Conditions
- Neonatal Acute Renal Failure in Preterm
- Keywords
- preterm infants, acute renal failure, nephronic reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases with neonatal acute renal failure in preterm | Experimental | Other: renal echography, Other: Blood sampling, Other: collection of an urine sample, Other: Blood pressure measurement |
| controls without neonatal acute renal failure in preterm | Other | Other: renal echography, Other: Blood sampling, Other: collection of an urine sample, Other: Blood pressure measurement |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- no parental consent
- other causes of renal failure: congenital uropathy, congenital nephropathy
- congenital cardiopathy, polymalformative syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| renal echographyrenal echography to analyse the kidney | Other | cases with neonatal acute renal failure in preterm, controls without neonatal acute renal failure in preterm |
| Blood samplingBlood sampling to analyse different parameters of renal function | Other | cases with neonatal acute renal failure in preterm, controls without neonatal acute renal failure in preterm |
| collection of an urine sampleCollection of an urine sample to perform analysis of renal function parameters | Other | cases with neonatal acute renal failure in preterm, controls without neonatal acute renal failure in preterm |
| Blood pressure measurement | Other | cases with neonatal acute renal failure in preterm, controls without neonatal acute renal failure in preterm |
Primary outcome
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.
5 secondary outcomes
measurement of blood pressure
Time frame: Day 1 (at inclusion)
measurement of length and volume of kidney by renal echography
Time frame: day 1
creatinine clearance
Time frame: day 1
calciuria
Time frame: Day 1
sodium clearance
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 27335060Bruel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma ALLAIN-LAUNAY, PH principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing renal echography, Blood sampling and collection of an urine sample in people with Neonatal Acute Renal Failure in Preterm, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microalbuminuria (time frame: Day 1 (at inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01785238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.