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

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Civil Hospices of Lyon

Status

Unknown

Conditions

Congenital Urine Flow Impairment

Treatments

Other: Laboratory biomarker analysis on urine sample

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

1 to 3 months old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

200 participants in 2 patient groups

children with congenital urine flow impairment
Description:
this group contain children with an unilateral urinary tract dilatation diagnosed by prenatal ultrasonography
Treatment:
Other: Laboratory biomarker analysis on urine sample
control group
Description:
this group contains children, between 1 and 3 months of age, without nephrological or urological anomaly
Treatment:
Other: Laboratory biomarker analysis on urine sample

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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