Change of Urinary Metabolic Profile Secondary to a Congenital Urine Flow Impairment (UFI) by Nuclear Magnetic Resonance (NMR) and Metabolomics Analysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2016-12-31

Brief Summary

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For the new-born, diagnosis and prognosis of congenital urine flow impairment (UFI) are difficult to confirm only with morphological examination (ultrasonography, intravenous pyelography) and functional examination (dynamic renal scan MAG3). Only the test of time allows the post confirmation of a significant UFI requiring a surgery. This meant that the actual therapeutic indications are imperfect by the absence of an "absolute" endpoint for UFI.

The objective of the study is to characterize the urinary metabolomics profile of new born with renal pelvis and/or ureters tract dilatation (suspicion of pelvi-ureteric junction anomalies, primary megaureter and vesico-ureteric reflux), detected by prenatal ultrasonography, by Nuclear Magnetic Resonance (NMR) and metabolomics analysis. This characterization will allow the identification of statistically significant metabolomics markers for the diagnosis and prognosis of a favourable evolution of the anomaly. The evolution with time of these metabolomics profiles will also considered.

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Detailed Description

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Conditions

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Congenital Urine Flow Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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children with congenital urine flow impairment

this group contain children with an unilateral urinary tract dilatation diagnosed by prenatal ultrasonography

Laboratory biomarker analysis on urine sample

Intervention Type OTHER

Archived urine samples are analyzed for specific metabolite patterns by nuclear magnetic resonance

control group

this group contains children, between 1 and 3 months of age, without nephrological or urological anomaly

Laboratory biomarker analysis on urine sample

Intervention Type OTHER

Archived urine samples are analyzed for specific metabolite patterns by nuclear magnetic resonance

Interventions

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Laboratory biomarker analysis on urine sample

Archived urine samples are analyzed for specific metabolite patterns by nuclear magnetic resonance

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Newborns or infants between 1 and 3 months of age,
* who present an upper urinary tract dilatation detected on prenatal ultrasound scanning, and confirmed with a postnatal sonographic investigation between D4 and D10 of life showing a renal pelvis with an anteroposterior diameter \> 10 mm and/or an ureters \> 6 mm,
* Written, informed consent obtained from the 2 parents

* Newborns or infants between 1 and 3 months of age,
* Written, informed consent obtained from the 2 parents

* urological associated anomaly: bladder dysfunction, solitary kidney, bilateral pathology,
* Absence of parents consent

* Nephrologic or urological anomaly
* Previous medical conditions or prior surgery; except minor surgery (inguinal hernia, umbilical hernia, hypertrophic pyloric stenosis…..)
* Absence of parents consent

Minimum Eligible Age

1 Month

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes