Pleconaril and ribavirin in new-onset type 1 diabetes: a phase 2 randomized trial.

Previous studies showed a low-grade enterovirus infection in the pancreatic islets of patients with newly diagnosed type 1 diabetes (T1D). In the Diabetes Virus Detection (DiViD) Intervention, a phase 2, placebo-controlled, randomized, parallel group, double-blind trial, 96 children and adolescents (aged 6-15 years) with new-onset T1D received antiviral treatment with pleconaril and ribavirin (n = 47) or placebo (n = 49) for 6 months, with the aim of preserving ß cell function. The primary endpoint was the mean stimulated C-peptide area under the curve (AUC) 12 months after the initiation of treatment (less than 3 weeks after diagnosis) using a mixed linear model. The model used longitudinal log-transformed serum C-peptide AUCs at baseline, at 3 months, 6 months and 1 year. The primary endpoint was met with the serum C-peptide AUC being higher in the pleconaril and ribavirin treatment group compared to the placebo group at 12 months (average marginal effect = 0.057 in the linear mixed model; 95% confidence interval = 0.004-0.11, P = 0.037). The treatment was well tolerated. The results show that antiviral treatment may preserve residual insulin production in children and adolescent with new-onset T1D. This provides a rationale for further evaluating antiviral strategies in the prevention and treatment of T1D. European Union Drug Regulating Authorities Clinical Trials identifier: 2015-003350-41 .

A comparison between two NIRS oximeters (INVOS, OxyPrem) using measurement on the arm of adults and head of infants after caesarean section.

Previously the NIRS oximeter OxyPrem was calibrated by comparison to the INVOS in a blood-lipid phantom. The aim of the present study was to test this calibration clinically. During vasculur occlusions in 10 adults and after birth in 25 term infants the relationship was OxyPrem = 1.24 x INVOS - 23.6% and OxyPrem = 1.15 x INVOS - 16.2% on the adult arm and infant head, respectively. The precsion during steady state was 4.0% (CI 3.4% to 4.6%) and 3.4% (CI 2.9% to 3.9%) on the arm, and 6.7% (CI 5.9% to 7.6%) and 4.7% (CI 3.5% to 5.9%) on the infant head for OxyPrem and INVOS, respectively. We conclude that the calibration on the blood-lipid phantom was unsuccessful in achieving agreement in clinical measurements.

Peripheral tissue oximetry: comparing three commercial near-infrared spectroscopy oximeters on the forearm.

Estimation of regional tissue oxygenation (rStO2) by near infrared spectroscopy enables non-invasive end-organ oxygen balance monitoring and could be a valuable tool in intensive care. However, the diverse absolute values and dynamics of different devices, and overall poor repeatability of measurements are a problem. The aim of the present study is to test the hypothesis that INVOS 5100C, FORE-SIGHT and NONIN EQUANOX 7600 have similar properties concerning absolute values, repeatability, and sensitivity to changes in rStO2. To test repeatability the sensors were repositioned 20 times during hemodynamic steady state on the adult forearm. Afterwards six vascular occlusions by inflation of an upper arm cuff were done to achieve low oxygenation in the forearm. Absolute values were compared by repeated-measures ANOVA, repeatability was estimated by the within-subject standard deviation, Sw, and response to changing oxygenation by the down slope of rStO2 during vascular occlusion in the respective arm. 10 healthy adults, 21-29 years old, with double skinfolds on the forearm less than 10 mm participated. The median rStO2 was 70.7% (interquartile range (IQR) 7.7%), 68.4% (IQR 8.4%), and 64.6% (IQR 4.8) with INVOS, NONIN, and FORE-SIGHT, respectively, the median rate of decline was 13.2%/min (IQR 9.6), 22.8 %/min (IQR 18.0), and 10.8%/min (IQR 6.0), and the same-site repeatability was 2.9% (95% CI 2.4-3.3), 4.6% (CI 3.9-5.3), and 2.0% (CI 1.7-2.3). INVOS gave significantly higher steady state values than FORE-SIGHT, and NONIN had the steepest decline in rStO2, but the poorest repeatability. Two measures of signal-to-noise were similar among devices. This suggests that good repeatability comes at the expense of low sensitivity to changes in oxygenation. Values of rStO2 on the forearm from INVOS, NONIN and FORE-SIGTH cannot be used interchangeably.

Somatic growth in 94 single ventricle children -- comparing systemic right and left ventricle patients.

AIM: We sought to compare and assess growth in single ventricle children with a systemic right or left ventricle in five time periods: at birth, before neonatal surgery, before the Glenn anastomosis and finally before and after the Fontan operation to 11 years of age. METHODS: We reviewed medical records on 116 single ventricle patients operated at Rigshospitalet, Denmark from 1987 to 2007. Surgical procedures, feeding route, hemodynamic variables and anthropometric measurements such as weight and height were registered and converted to z-scores. RESULTS: Ninety four single ventricle patients were included for analysis. Gestational age and birth weight was not significantly different between the left and right ventricle group. Before neonatal surgery and before the Glenn anastomosis, both groups showed equal growth retardation. However, a significant difference in catch-up growth was found before the Fontan operation. Thus, patients in the right ventricle group had a smaller median weight-for-age z-score compared with the left ventricle group in the pre-Fontan period (-1.9 and -1.6; p = 0.049) and in the post-Fontan period (-1.1 and -0.7; p = 0.034). CONCLUSION: After the Glenn anastomosis single ventricle children with a systemic left ventricle have better weight gain compared with children with a systemic right ventricle.