Clinical trial NCT02792348: Change of Urinary Metabolic Profile Secondary to a Congenital Urine Flow Impairment (UFI) by Nuclear Magnetic Resonance (NMR) and Metabolomics Analysis
Official title: Change of Urinary Metabolic Profile Secondary to a Congenital Urine Flow Impairment (UFI) by Nuclear Magnetic Resonance (NMR) and Metabolomics Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Urine Flow Impairment
Keywords: congenital urine flow impairment
urinary metabolomics profile
Nuclear Magnetic Resonance
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients (newborns or infants between 1 and 3 months of age) will be enrolled outpatient uro-visceral service of HFME hospital.

Brief 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.


Eligibility criteria: * 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

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.
timeFrame: 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.
timeFrame: Urine samples of patients will be collected at the follow-up visits between 9 and 12 months of age (M9-M12).
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de LYon - Hôpital Femme Mère Enfant
Study officials:
References: