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Background: Convulsive status epilepticus (CSE) is the most common life-threatening neurological emergency in childhood. These children are also at risk of significant morbidity, with acute and chronic impact on the family and the health and social care systems. The current recommended first-choice, second-line treatment in children aged 6 months and above is intravenous phenytoin (fosphenytoin in the USA), although there is a lack of evidence for its use and it is associated with significant side effects. Emerging evidence suggests that intravenous levetiracetam may be effective as a second-line agent for CSE, and fewer adverse effects have been described. This trial therefore aims to determine whether intravenous phenytoin or levetiracetam is more effective, and safer, in treating childhood CSE.Methods/design: This is a phase IV, multi-centre, parallel group, randomised controlled, open-label trial. Following treatment for CSE with first-line treatment, children with ongoing seizures are randomised to receive either phenytoin (20 mg/kg, maximum 2 g) or levetiracetam (40 mg/kg, maximum 2.5 g) intravenously. The primary outcome measure is the cessation of all visible signs of CSE as determined by the treating clinician. Secondary outcome measures include the need for further anti-seizure medications or rapid sequence induction for ongoing CSE, admission to critical care areas, and serious adverse reactions. Patients are recruited without prior consent, with deferred consent sought at an appropriate time for the family. The primary analysis will be by intention-to-treat. The primary outcome is a time to event outcome and a sample size of 140 participants in each group will have 80% power to detect an increase in CSE cessation rates from 60% to 75%. Our total sample size of 308 randomised and treated participants will allow for 10% loss to follow-up.Discussion: This clinical trial will determine whether phenytoin or levetiracetam is more effective as an intravenous second-line agent for CSE, and provide evidence for management recommendations. In addition, this trial will also provide data on which of these therapies is safer in this setting.Trial Registration: ISRCTN identifier, ISRCTN22567894 . Registered on 27 August 2015 EudraCT identifier, 2014-002188-13 . Registered on 21 May 2014 NIHR HTA Grant: 12/127/134. [ABSTRACT FROM AUTHOR]

BACKGROUND AND OBJECTIVES: International patterns of antibiotic use and laboratory testing in bronchiolitis in emergency departments are unknown. Our objective is to evaluate variation in the use of antibiotics and nonindicated tests in infants with bronchiolitis in 38 emergency departments in Pediatric Emergency Research Networks in Canada, the United States, Australia and New Zealand, the United Kingdom and Ireland, and Spain and Portugal. We hypothesized there would be significant variation, adjusted for patient characteristics. METHODS: We analyzed a retrospective cohort study of previously healthy infants aged 2 to 12 months with bronchiolitis. Variables examined included network, poor feeding, dehydration, nasal flaring, chest retractions, apnea, saturation, respiratory rate, fever, and suspected bacterial infection. Outcomes included systemic antibiotic administration and urine, blood, or viral testing or chest radiography (CXR). RESULTS: In total, 180 of 2359 (7.6%) infants received antibiotics, ranging from 3.5% in the United Kingdom and Ireland to 11.1% in the United States. CXR (adjusted odds ratio [aOR] 2.3; 95% confidence interval 1.6-3.2), apnea (aOR 2.2; 1.1-3.5), and fever (aOR 2.4; 1.7-3.4) were associated with antibiotic use, which did not vary across networks (P = .15). In total, 768 of 2359 infants (32.6%) had ≥1 nonindicated test, ranging from 12.7% in the United Kingdom and Ireland to 50% in Spain and Portugal. Compared to the United Kingdom and Ireland, the aOR (confidence interval) results for testing were Canada 5.75 (2.24-14.76), United States 4.14 (1.70-10.10), Australia and New Zealand 2.25 (0.86-5.74), and Spain and Portugal 3.96 (0.96-16.36). Testing varied across networks (P < .0001) and was associated with suspected bacterial infections (aOR 2.12; 1.30-2.39) and most respiratory distress parameters. Viral testing (591 of 768 [77%]) and CXR (507 of 768 [66%]) were obtained most frequently. CONCLUSIONS: The rate of antibiotic use in bronchiolitis was low across networks and was associated with CXR, fever, and apnea. Nonindicated testing was common outside of the United Kingdom and Ireland and varied across networks irrespective of patient characteristics. [ABSTRACT FROM AUTHOR]