NCT01785238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 16, 2014

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

January 18, 2013

Last Update Submit

October 15, 2014

Conditions

Neonatal Acute Renal Failure in Preterm

Keywords

preterm infantsacute renal failurenephronic reduction

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (5)

  • measurement of blood pressure

    Day 1 (at inclusion)

  • measurement of length and volume of kidney by renal echography

    day 1

  • creatinine clearance

    day 1

  • calciuria

    Day 1

  • sodium clearance

    day 1

Study Arms (2)

cases with neonatal acute renal failure in preterm

EXPERIMENTAL
Other: renal echographyOther: Blood samplingOther: collection of an urine sampleOther: Blood pressure measurement

controls without neonatal acute renal failure in preterm

OTHER
Other: renal echographyOther: Blood samplingOther: collection of an urine sampleOther: Blood pressure measurement

Interventions

renal echographyOTHER

renal echography to analyse the kidney

cases with neonatal acute renal failure in pretermcontrols without neonatal acute renal failure in preterm
Blood samplingOTHER

Blood sampling to analyse different parameters of renal function

cases with neonatal acute renal failure in pretermcontrols without neonatal acute renal failure in preterm
collection of an urine sampleOTHER

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

cases with neonatal acute renal failure in pretermcontrols without neonatal acute renal failure in preterm
Blood pressure measurementOTHER
cases with neonatal acute renal failure in pretermcontrols without neonatal acute renal failure in preterm

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • no parental consent
  • other causes of renal failure: congenital uropathy, congenital nephropathy
  • congenital cardiopathy, polymalformative syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU of Nantes

Nantes, 44093, France

Location

Related Publications (1)

  • 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.

    PMID: 27335060DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Emma ALLAIN-LAUNAY, PH

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2013

First Posted

February 7, 2013

Study Start

February 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 16, 2014

Record last verified: 2014-10

Locations

FR(1)