Performance of a Quantitative PCR-Based Assay and Beta-d-Glucan Detection for Diagnosis of Invasive Candidiasis in Very-Low-Birth-Weight Preterm Neonatal Patients (CANDINEO Study)

An epidemiological, multicenter, noninterventional, observational case-control study was conducted to describe the performance of serum beta-d-glucan (BDG) and Candida PCR in blood, serum, and sterile samples for the diagnosis of invasive candidiasis (IC) in very-low-birth-weight (VLBW) preterm neonates and to compare these techniques with culture of samples from blood and other sterile sites. Seventeen centers participated in the study, and the number of episodes analyzed was 159. A total of 9 episodes of IC from 9 patients (7 confirmed and 2 probable) and 150 episodes of suspected sepsis from 117 controls were identified. The prevalence of IC was 5.7% (95% confidence interval [95% CI], 2.1 to 9.3). The mortality was significantly higher in episodes of IC (44.4%) than in the non-IC episodes (11.1%, P < 0.01). The sensitivity and specificity of the PCR performed on blood/serum samples were 87.5% and 81.6%, respectively. The sensitivity and specificity of the BDG results were lower (75.0% and 64.6%). For cases with negative culture results, the PCR and the BDG results were positive in 27 (17.4%) and 52 (33.5%) episodes, respectively. The presence of multiorgan failure, improvement with empirical antifungal therapy, thrombocytopenia, and Candida colonization were significantly associated (P < 0.01) with PCR or BDG positivity regardless of the results of the cultures. Serum BDG analysis and Candida PCR could be used as complementary diagnostic techniques to detect IC in VLBW neonates.This study was initiated and financially supported by Astellas Pharma Inc. Manuel Cuenca-Estrella has received grant support from Astellas Pharma Inc., bioMérieux, Basilea, Gilead Sciences, Merck Sharp & Dohme, Pfizer, Schering Plough, Soria Melguizo SA, Ferrer International, the European Union, the ALBAN program, the Spanish Agency for International Cooperation, the Spanish Ministry of Culture and Education, the Spanish Health Research Fund, Instituto de Salud Carlos III (Spanish Ministry of Economy and Competitiveness), the Ramon Areces Foundation, and the Mutua Madrileña Foundation. Jose T. Ramos has received fees for conferences from Gilead Sciences, ViiV Healthcare, and Janssen-Cilag and grant support from the Gilead Fellowship Program. Elena Bergon-Sendin received grant support from Astellas Pharma Inc. during the conduct of the study. Paloma Anguita Alonso is an employee of Astellas Pharma Inc. The rest of us have no conflicts to report. Medical writing support was provided by Lucy Kanan on behalf of Bioscript Medical Ltd., funded by Astellas Pharma IncS

Antimicrobial Defined Daily Dose in Neonatal Population: Validation in the Clinical Practice

Paediatric Antimicrobial Defined Daily Dose Study Group KiDDDs.Currently, there is no validated method for estimating antimicrobial consumption in the neonatal population, as it exists for adults using Defined Daily Doses (DDD). In neonatology, although there are different methods, each one with advantages and disadvantages, there is no unified criterion for use. The aim of this study is to validate the neonatal DDD designed as a new standardised form of antimicrobial consumption over this population.M.M.-T. received financial support from the Subprograma Río Hortega, Instituto de Salud Carlos III, Subdirección General de Redes y Centros de Investigación Cooperativa, Ministerio de Ciencia, Innovación y Universidades, Spain (CM21/00115). The project has been carried out without financial funding but is supported by the Spanish Society of Hospital Pharmacy (SEFH), the Working Group on Pharmaceutical Care in Infectious Diseases of the SEFH (Afinf) and Spanish working group on paediatric pharmacy of the SEFH (gefp).Peer reviewe

Auditing of Monitoring and Respiratory Support Equipment in a Level III-C Neonatal Intensive Care Unit

Background. Random safety audits (RSAs) are a safety tool but have not been widely used in hospitals. Objectives. To determine the frequency of proper use of equipment safety mechanisms in relation to monitoring and mechanical ventilation by performing RSAs. The study also determined whether factors related to the patient, time period, or characteristics of the area of admission influenced how the device safety systems were used. Methods. A prospective observational study was conducted in a level III-C Neonatal Intensive Care Unit (NICU) during 2012. 87 days were randomly selected. Appropriate overall use was defined when all evaluated variables were correctly programmed in the audited device. Results. A total of 383 monitor and ventilator audits were performed. The Kappa coefficient of interobserver agreement was 0.93. The rate of appropriate overall use of the monitors and respiratory support equipment was 33.68%. Significant differences were found with improved usage during weekends, OR 1.85 (1.12–3.06, p=0.01), and during the late shift (3 pm to 10 pm), OR 1.59 (1.03–2.4, p=0.03). Conclusions. Equipment safety systems of monitors and ventilators are not properly used. To improve patient safety, we should identify which alarms are really needed and where the difficulties lie for the correct alarm programming

Cerebral Oximetry Monitoring in Extremely Preterm Infants

Background: The use of cerebral oximetry monitoring in the care of extremely preterm infants is increasing. However, evidence that its use improves clinical outcomes is lacking. Methods: In this randomized, phase 3 trial conducted at 70 sites in 17 countries, we assigned extremely preterm infants (gestational age, &lt;28 weeks), within 6 hours after birth, to receive treatment guided by cerebral oximetry monitoring for the first 72 hours after birth or to receive usual care. The primary outcome was a composite of death or severe brain injury on cerebral ultrasonography at 36 weeks' postmenstrual age. Serious adverse events that were assessed were death, severe brain injury, bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and late-onset sepsis. Results: A total of 1601 infants underwent randomization and 1579 (98.6%) were evaluated for the primary outcome. At 36 weeks' postmenstrual age, death or severe brain injury had occurred in 272 of 772 infants (35.2%) in the cerebral oximetry group, as compared with 274 of 807 infants (34.0%) in the usual-care group (relative risk with cerebral oximetry, 1.03; 95% confidence interval, 0.90 to 1.18; P = 0.64). The incidence of serious adverse events did not differ between the two groups. Conclusions: In extremely preterm infants, treatment guided by cerebral oximetry monitoring for the first 72 hours after birth was not associated with a lower incidence of death or severe brain injury at 36 weeks' postmenstrual age than usual care. (Funded by the Elsass Foundation and others; SafeBoosC-III ClinicalTrials.gov number, NCT03770741.)