Pediatric nephrology : journal of the International Pediatric Nephrology Association
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Randomized Controlled Trial Comparative Study
Randomized cross-over trial comparing albumin and frusemide infusions in nephrotic syndrome.
The contribution of hypoalbuminemia to impaired diuretic responsiveness can be overcome by administering larger doses of loop diuretics. However, the clinical efficacy of the combination of loop-acting diuretics with human albumin remains controversial. ⋯ At the end of study, median urine volume was 3.27 [95% confidence interval (CI) 2.04-4.50] ml/kg per hour in the HA+FU infusion group and 1.33 (95% CI 0.79-1.88) ml/kg per hour in the FU infusion group (P = 0.01); the median daily sodium excretion was 58 (95% CI 30-366) mEq and 30 (95% CI 10-122) mEq (P = 0.08), respectively The changes in other variables included weight loss [HA+FU 5.2% (95% CI 3.1-8.8); FU 0.8% (95% CI -1.9 to 4.1); P = 0.006]; urine osmolality [HA+FU 315 (95% CI 220-426) mOsm/kg; FU 368 (95% CI 318-446) mOsm/kg; P = 0.13]; osmolal clearance [HA+FU 1600 (95% CI 916-4140) ml/day; FU 880 (95% CI 510-2105) ml/day; P = 0.01; free water clearance [HA+FU -190 (95% CI -960 to 280) ml/day; FU -162 (95% CI -446 to -70) ml/day; P = 0.18]. The findings from this study suggest that the co-administration of albumin and frusemide infusions is more effective than the administration of frusemide infusion alone in inducing diuresis and natriuresis in patients with nephrotic syndrome.
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Randomized Controlled Trial Multicenter Study Comparative Study
Ceftibuten versus trimethoprim-sulfamethoxazole for oral treatment of febrile urinary tract infection in children.
A randomized, open, coordinated multi-center trial compared the bacteriological and clinical efficacy and safety of orally administered ceftibuten and trimethoprim-sulfamethoxazole (TMP-SMX) in children with febrile urinary tract infection (UTI). Children aged 1 month to 12 years presenting with presumptive first-time febrile UTI were eligible for enrollment. A 2:1 assignment to treatment with ceftibuten 9 mg/kg once daily (n = 368) or TMP-SMX (3 mg + 15 mg)/kg twice daily (n = 179) for 10 days was performed. ⋯ However, the clinical cure rate was significantly higher among those treated with ceftibuten (93 vs. 83%, with a 95% CI for difference of 2.4 to 17.0). Adverse events were similar for both regimens and consisted mainly of gastrointestinal disturbances. In conclusion, ceftibuten is a safe and effective drug for the empirical treatment of febrile UTI in young children.
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Randomized Controlled Trial Comparative Study
Probiotics prophylaxis in children with persistent primary vesicoureteral reflux.
Probiotics, beneficial living microorganisms, have been proven to be effective in preventing gastrointestinal infections, but their effect in preventing urinary tract infection (UTI) is inconclusive. A prospective randomized controlled study was done to compare the preventive effect of probiotics with conventional antibiotics in children with persistent primary vesicoureteral reflux (VUR). One hundred twenty children who had had persistent primary VUR after antibiotic prophylaxis for 1 year were randomly allocated into a probiotics (Lactobacillus acidophilus 10(8) CFU/g 1 g b.i.d., n = 60) or an antibiotics (trimethoprim/sulfamethoxazole 2/10 mg/kg h.s., n = 60) prophylaxis group during the second year of follow-up. ⋯ Even after stratification by VUR grade, age, gender, phimosis, voiding dysfunction and renal scar, the incidence of recurrent UTI did not differ significantly between the two groups (P > 0.05). The development of new renal scar was not significantly different between the two groups (P > 0.05). In conclusion, probiotics prophylaxis was as effective as antibiotic prophylaxis in children with persistent primary VUR.
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Randomized Controlled Trial Multicenter Study
Darbepoetin alfa for the treatment of anemia in pediatric patients with chronic kidney disease.
Darbepoetin alfa, an erythropoiesis-stimulating glycoprotein, has proved efficacious in the treatment of anemia of chronic kidney disease (CKD) in adult subjects. However, little information is available from pediatric populations. We conducted an open-label, non-inferiority, 28-week study comparing the efficacy of darbepoetin alfa with that of recombinant human erythropoietin (rHuEpo) in pediatric subjects with CKD. ⋯ Darbepoetin alfa was considered to be non-inferior to rHuEpo if the lower limit of the two-sided 95% confidence interval (CI) for the difference in the mean change in Hb between the two treatment groups was above -1.0 g/dl. The adjusted mean change in Hb between the baseline and the evaluation period for the rHuEpo and darbepoetin alfa groups was -0.16 g/dl and 0.15 g/dl, respectively, with a difference of 0.31 g/dl (95% CI: -0.45, 1.07) between the means. These results, and the comparable safety profiles, demonstrate that darbepoetin alfa is non-inferior to rHuEpo in the treatment of anemia in pediatric patients with CKD.
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Randomized Controlled Trial Clinical Trial
Premedication during micturating cystourethrogram to achieve sedation and anxiolysis.
Micturating cystourethrogram (MCUG) is an imaging technique indicated in the diagnosis and follow-up of many diseases. We investigated the reliability and the efficacy of midazolam and chloral hydrate in sedation and anxiolysis during micturating cystourethrogram. Fifty-three children of similar ages (39 girls, 14 boys, mean age of 5.8+/-3.5 years) were randomized to midazolam (n=17), chloral hydrate (n=18) and control groups (n=18). ⋯ Bladder capacity and frequency of detection of residual urine were not statistically different between the three study groups (P>0.05). Vital signs did not change significantly in any child. Sedation with midazolam does not have adverse effects on the results of micturating cystourethrogram, while it reduces the discomfort in children undergoing this radiological technique.