Overview

This trial is active, not recruiting.

Condition congenital urine flow impairment
Treatment laboratory biomarker analysis on urine sample
Sponsor Hospices Civils de Lyon
Start date February 2011
End date January 2015
Trial size 200 participants
Trial identifier NCT02792348, D50720

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
this group contain children with an unilateral urinary tract dilatation diagnosed by prenatal ultrasonography
laboratory biomarker analysis on urine sample
Archived urine samples are analyzed for specific metabolite patterns by nuclear magnetic resonance
this group contains children, between 1 and 3 months of age, without nephrological or urological anomaly
laboratory biomarker analysis on urine sample
Archived urine samples are analyzed for specific metabolite patterns by nuclear magnetic resonance

Primary Outcomes

Measure
NMR identification of urinary metabolomics markers for diagnosis and prognosis of UFI (suspicion of pelvi-ureteric junction anomalies, primary megaureter and vesico-ureteric reflux) detected in prenatal ultrasonography.
time frame: Urine samples of patients will be collected at recruitment time (Day 0).

Secondary Outcomes

Measure
change of the urinary metabolomics profile change of UFI (pelvi-ureteric junction anomalies, primary megaureter and vesico-ureteric reflux) during the follow-up.
time frame: Urine samples of patients will be collected at the follow-up visits between 9 and 12 months of age (M9-M12).

Eligibility Criteria

Male or female participants from 1 month up to 3 months old.

- Inclusion Criteria - UFI group: - 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 - Inclusion Criteria - control group: - Newborns or infants between 1 and 3 months of age, - Written, informed consent obtained from the 2 parents - Non-inclusion Criteria - UFI group: - urological associated anomaly: bladder dysfunction, solitary kidney, bilateral pathology, - Absence of parents consent - Non-inclusion Criteria - control group: - Nephrologic or urological anomaly - Previous medical conditions or prior surgery; except minor surgery (inguinal hernia, umbilical hernia, hypertrophic pyloric stenosis…..) - Absence of parents consent

Additional Information

Official title Change of Urinary Metabolic Profile Secondary to a Congenital Urine Flow Impairment (UFI) by Nuclear Magnetic Resonance (NMR) and Metabolomics Analysis
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.