ultrasonography: bilateral ultrasonography to measure the antero-posterior renal pelvic diameter (APRPD) in both positions.
diuretic renography: diuretic renography to measure the cortical transit time.
Study summary
Cortical transit time on diuretic renogram as an early marker of significant obstruction in antenatally detected uretero-pelvic junction syndrome
Eligibility
Sex
ALL
Min age
4 Weeks
Max age
8 Weeks
Healthy volunteers
No
Inclusion Criteria:
Infants:
* Aged of 4 to 8 weeks of life
* Presenting an ureteropelvic junction obstruction (UPJO) detected before birth by ultrasound
* Presenting an UPJO, defined by an Antero-Posterior Renal Pelvic Diameter greater or equal to 15 mm, confirmed by ultrasound post-natally between the 1st and 15th day of life
* Presenting a unilateral UPJO
* whose legal representatives have provided a signed free and informed written consent for their infant's participation
* whose at least one of his legal representative is affiliated to national social security
Exclusion Criteria:
Infants presenting:
* A bilateral UPJO
* An ureteral dilatation
* An associated contralateral uropathy
* A solitary kidney
* A renal insufficiency
* Severe associated disabilities ( ie polymalformation syndromes)
* A concomitant participation in another trial
* A contraindication to furosemide (acute renal insufficiency, hepatic encephalopathy, hypovolemia or dehydration, severe hypokalemia, severe hyponatremia)
* A contraindication to the radionuclide marker (hypersensitivity to the active substance or to excipients)
Primary outcome measure(s)
risk, during the first year of life, of an increase of 4mm or more in the measure of APRPD by ultrasonography as compared to the baseline measure, according to the presence or not of an abnormal cortical transit ti — 3 months, 6 months and 12 months During the first year of life, the antero-posterior renal pelvic diameter will be measured by ultrasonography at baseline, then at 3 months, 6 months and 12 months after baseline.
Diuretic renography will be performed only at baseline and the cortical transit time will be classified as normal or abnormal.
An increase of 4mm or more of APRPD is the threshold chosen in the study to determine the aggravation of hydronephrosis.
The occurence of the increase of 4mm or more in the measure of APRPD will be compared with the normality/abnormality of the cortical transit time in order to determine its value as a prognostic marker.
Trial sites (5)
Facility
City
Region
Status
CHU de Bordeaux
Bordeaux
France
Recruiting
CHU de Limoges
Limoges
France
Recruiting
CHU de Nantes
Nantes
France
Not Yet Recruiting
CHU de Rennes
Rennes
France
Not Yet Recruiting
Centre Hospitalier Universitaire de La Réunion
Saint-Denis
France
Recruiting
More Centre Hospitalier Universitaire de la Réunion trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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