Renal safety in pediatric imaging: randomized, double-blind phase IV clinical trial of iobitridol 300 versus iodixanol 270 in multidetector CT.

BACKGROUND: It is debated whether iso-osmolar and low-osmolar contrast media are associated with different incidences of contrast medium-induced nephropathy (CIN) in patients with renal insufficiency. OBJECTIVE: To compare the incidence of CIN in children undergoing contrast-enhanced multidetector computer tomography (MDCT) with intravenous injection of low-osmolar (iobitridol, Xenetix® 300) or an iso-osmolar (iodixanol, Visipaque® 270) iodinated contrast medium. MATERIALS AND METHODS: One hundred forty-six children with normal renal function were included in this multicenter trial and underwent contrast-enhanced MDCT. The primary endpoint was the relative change in creatinine clearance from 48 h pre- to 72 h postcontrast medium administration using a noninferiority analysis in the intent-to-treat (ITT, n = 128) and per protocol (n = 68) populations. Secondary endpoints were incidence of CIN, global image quality, diagnostic efficacy and clinical safety. RESULTS: In the ITT population, the noninferiority of iobitridol over iodixanol was demonstrated. CIN incidence was 4.8% (three cases) with iobitridol and 10.6% (seven cases) with iodixanol (not significant). No statistically significant differences were observed for the secondary endpoints. CONCLUSION: Comparable satisfactory safety profiles were confirmed for both contrast media, with no significant difference in the incidence of CIN in children with normal renal function.

Uterus didelphys, hemihydrocolpos and empty ipsilateral lumbar fossa in a newborn girl: involuted dysplastic kidney rather than renal agenesis.

We report a case of Herlyn-Werner-Wunderlich syndrome diagnosed in the neonatal period. US revealed the classic association of a uterus didelphys with blind hemivagina and no ipsilateral kidney. The diagnosis was established by postnatal US and confirmed by MRI. Differential diagnoses are discussed. A trans-hymeneal resection of the vaginal septum was performed at 1 month of age. Intra operative endoscopy revealed no left hemitrigone but showed an atretic orifice in the ipsilateral blind hemivagina, probably corresponding to the insertion of an ectopic ureter. Follow-up was unremarkable.

Anterior axial ultrasound in monitoring infants with Pavlik harness.

Real-time ultrasonography has been used for diagnosis and screening of developmental dysplasia of the hip for several years. If diagnostic criteria are well established, the use of sonography in follow-up of treated infants remains extremely variable. The aims of this study were (a). to describe the normal sonographic anatomy of the infant abducted hip on an anterior axial view, and (b). to define the role of this approach in the follow-up of developmental dysplasia treated by Pavlik harness. Thirty-eight patients with Pavlik harness had anterior axial sonograms in addition to their usual clinical and sonographic follow-up. Normal anatomy was inferred from the examination of 25 clinically proven normal hips in the same population. The best criterion of a normal positioning of the femoral head appears to be the alignment of the pubic bone and the femoral metaphysis. Pavlik harness was the only treatment in 32 patients. It was directly efficient in 22, after readjustment in 10 patients. Reduction was shown by anterior sonography in all of them. In 6 children, sonography showed no reduction and subsequent treatment by closed or open reduction was carried out. Anterior axial sonogram can show reduction of a dislocated hip in children with Pavlik harness, but it does not evaluate its stability. It helps optimize the settings of the harness, and may predict a poor outcome, but it does not identify the cause of non-reducibility.