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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| children with congenital urine flow impairment | this group contain children with an unilateral urinary tract dilatation diagnosed by prenatal ultrasonography |
| |
| control group | this group contains children, between 1 and 3 months of age, without nephrological or urological anomaly |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory biomarker analysis on urine sample | Other | Archived urine samples are analyzed for specific metabolite patterns by nuclear magnetic resonance |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Urine will be stored at _80 _C before acquisition of the NMR data. Urine samples will be thawed at room temperature before use. 400µL of supernatant will be diluted with 200 µL of a buffer solution Na2HPO4/NaH2PO4 (pH = 7.4; 20% D2O/H2O v.v, internal reference: 3-(trimethylsilyl)propionic,2-2-3-3-d4 acid) in Eppendorf tubes. Each sample will be centrifuged for 5 min at 4°C at 12,000 g. Finally, 550 µL will be transferred into 5 mm NMR tubes for analysis. Standard 1H 1D NMR pulse sequences, NOESY and CPMG with water presaturation, will be applied on each sample to obtain corresponding metabolic profiles. In addition, 2D NMR experiments (1H-1H TOCSY or 1H-13C HSQC, and 1H J-Resolved) will be recorded to achieve structural assignment of the metabolic signals. | Urine samples of patients will be collected at recruitment time (Day 0). |
| Measure | Description | Time Frame |
|---|---|---|
| change of the urinary metabolomics profile change of UFI (pelvi-ureteric junction anomalies, primary megaureter and vesico-ureteric reflux) during the follow-up. | Urine will be stored at _80 _C before acquisition of the NMR data. Urine samples will be thawed at room temperature before use. 400µL of supernatant will be diluted with 200 µL of a buffer solution Na2HPO4/NaH2PO4 (pH = 7.4; 20% D2O/H2O v.v, internal reference: 3-(trimethylsilyl)propionic,2-2-3-3-d4 acid) in Eppendorf tubes. Each sample will be centrifuged for 5 min at 4°C at 12,000 g. Finally, 550 µL will be transferred into 5 mm NMR tubes for analysis. Standard 1H 1D NMR pulse sequences, NOESY and CPMG with water presaturation, will be applied on each sample to obtain corresponding metabolic profiles. In addition, 2D NMR experiments (1H-1H TOCSY or 1H-13C HSQC, and 1H J-Resolved) will be recorded to achieve structural assignment of the metabolic signals. |
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Inclusion Criteria - UFI group:
Inclusion Criteria - control group:
Non-inclusion Criteria - UFI group:
Non-inclusion Criteria - control group:
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All patients (newborns or infants between 1 and 3 months of age) will be enrolled outpatient uro-visceral service of HFME hospital.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de LYon - Hôpital Femme Mère Enfant | Bron | 69500 | France |
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De-identified and study coded urine samples.
| Urine samples of patients will be collected at the follow-up visits between 9 and 12 months of age (M9-M12). |