Levosimendan versus milrinone in neonates and infants after corrective open-heart surgery: a pilot study.

OBJECTIVE: Low cardiac output syndrome commonly complicates the postoperative course after open-heart surgery in children. To prevent low cardiac output syndrome, prophylactic administration of milrinone after cardiopulmonary bypass is commonly used in small children. The aim of this study was to compare the effect of prophylactically administered levosimendan and milrinone on cardiac index in neonates and infants after corrective open-heart surgery. DESIGN: Prospective, single-center, double-blind, randomized pilot study. SETTING: Tertiary care center, postoperative pediatric cardiac intensive care unit. PATIENTS: After written informed consent, 40 infants undergoing corrective open-heart surgery were included. INTERVENTIONS: At weaning from cardiopulmonary bypass, either a 24-hr infusion of 0.1 µg/kg/min levosimendan or of 0.5 µg/kg/min milrinone were administered. Cardiac output was evaluated at 2, 6, 9, 12, 18, 24, and 48 hrs after cardiopulmonary bypass using a transesophageal Doppler technique (Cardio-QP, Deltex Medical, Chichester, UK). Cardiac index was calculated from cardiac output and the patients' respective body surface area. RESULTS: Intention-to-treat data of 39 patients (19 in the levosimendan and 20 in the milrinone group) were analyzed using analysis of variance for repeated measurements for statistics. Analysis of variance revealed for both, cardiac index and cardiac output, similar results with no significant differences of the factors group and time. A significant interaction for cardiac output (p = .005) and cardiac index (p = .007) was found, which indicates different time courses of cardiac index in the two groups. Both drugs were well tolerated; no death or serious adverse event occurred. CONCLUSIONS: In our small study, postoperative cardiac index over time was similar in patients with prophylactically administered levosimendan and patients with prophylactically given milrinone. We observed an increase in cardiac output and cardiac index over time in the levosimendan group, whereas cardiac output and cardiac index remained stable in the milrinone group. This pilot study has primarily served to obtain experience using the new drug levosimendan in neonates and infants and to initiate further multicenter trials in pediatric patients.

Must screening examinations for retinopathy of prematurity necessarily be painful?

PURPOSE: This study investigates the impact of the length of the examination, the insertion of eyelid specula, and the indentation of the globe on the pain and stress sensation of premature infants. METHODS: Ninety-two premature infants in three neonatal wards were included. In two wards, the patients were examined using eyelid specula and scleral indentation as recommended in the official guidelines. In the third ward, the investigation time was minimized and ophthalmoscopy was performed without eyelid specula and scleral indentation. Physical and mental disturbance of the patients was assessed by the Neonatal Infant Pain Score and by monitoring the heart rate. The results were divided into two groups: in the one, eyelid specula and scleral indentation were used, whereas in the other one, they were not used. An independent-samples t-test was performed, which allowed us to calculate the correlation between the way the examination was executed and the condition of the patients. RESULTS: Demographic data and baseline values of heart rate and pain score did not differ between the two groups. Heart rate and pain score during and after the investigation were significantly higher and increased significantly with the duration of the examination for the patients who were investigated using lid specula and scleral indentation. CONCLUSION: Our study shows that indirect ophthalmoscopy without specula causes significantly less stress to infants than screening with lid specula and scleral indentation.

[FSME monitoring: monitoring of adverse events of tick-borne-encephalitis vaccines by selected paediatricians and general practitioners]. / FSME-Monitoring: Monitoring von Impfnebenwirkungen und -reaktionen auf die FSME-Impfung durch ausgewählte niedergelassene Pädiater und Allgemeinmediziner.

The Institute for Vaccine-Safety of the Austrian Green Cross, the so-called "Institut für Impfsicherheit des Osterreichischen Grünen Kreuzes", promoted a postmarketing sentinel study referring to the safety of tick-borne-encephalitis vaccines in spring 2002. Five-hundred selected paediatricians and general practitioners took part and generated data on 25,905 administered doses. They reported on 107/25,907 (0.413 %) local and systemic adverse reactions. The leading side-effect was fever, besides other adverse reactions corresponding to those known in the literature. The age-group most often affected was that of toddlers and infants. Monitoring with the help of selected paediatricians and general practitioners, carried out alongside the routine obligatory procedures of monitoring, proved to be a valid instrument for detecting vaccine adverse events of tick-borne-encephalitis vaccines.