Up to 7% of term and late-preterm neonates in high-income countries receive antibiotics during the first 3 days of life because of suspected early-onset sepsis. The prevalence of culture-proven ...early-onset sepsis is 0·1% or less in high-income countries, suggesting substantial overtreatment. We assess whether procalcitonin-guided decision making for suspected early-onset sepsis can safely reduce the duration of antibiotic treatment.
We did this randomised controlled intervention trial in Dutch (n=11), Swiss (n=4), Canadian (n=2), and Czech (n=1) hospitals. Neonates of gestational age 34 weeks or older, with suspected early-onset sepsis requiring antibiotic treatment were stratified into four risk categories by their treating physicians and randomly assigned 1:1 using a computer-generated list stratified per centre to procalcitonin-guided decision making or standard care-based antibiotic treatment. Neonates who underwent surgery within the first week of life or had major congenital malformations that would have required hospital admission were excluded. Only principal investigators were masked for group assignment. Co-primary outcomes were non-inferiority for re-infection or death in the first month of life (margin 2·0%) and superiority for duration of antibiotic therapy. Intention-to-treat and per-protocol analyses were done. This trial was registered with ClinicalTrials.gov, number NCT00854932.
Between May 21, 2009, and Feb 14, 2015, we screened 2440 neonates with suspected early-onset sepsis. 622 infants were excluded due to lack of parental consent, 93 were ineligible for reasons unknown (68), congenital malformation (22), or surgery in the first week of life (3). 14 neonates were excluded as 100% data monitoring or retrieval was not feasible, and one neonate was excluded because their procalcitonin measurements could not be taken. 1710 neonates were enrolled and randomly assigned to either procalcitonin-guided therapy (n=866) or standard therapy (n=844). 1408 neonates underwent per-protocol analysis (745 in the procalcitonin group and 663 standard group). For the procalcitonin group, the duration of antibiotic therapy was reduced (intention to treat: 55·1 vs 65·0 h, p<0·0001; per protocol: 51·8 vs 64·0 h; p<0·0001). No sepsis-related deaths occurred, and 9 (<1%) of 1710 neonates had possible re-infection. The risk difference for non-inferiority was 0·1% (95% CI −4·6 to 4·8) in the intention-to-treat analysis (5 0·6% of 866 neonates in the procalcitonin group vs 4 0·5% of 844 neonates in the standard group) and 0·1% (−5·2 to 5·3) in the per-protocol analysis (5 0·7% of 745 neonates in the procalcitonin group vs 4 0·6% of 663 neonates in the standard group).
Procalcitonin-guided decision making was superior to standard care in reducing antibiotic therapy in neonates with suspected early-onset sepsis. Non-inferiority for re-infection or death could not be shown due to the low occurrence of re-infections and absence of study-related death.
The Thrasher Foundation, the NutsOhra Foundation, the Sophia Foundation for Scientific research.
Abstract
BACKGROUND: Simulation is an effective tool in medical education. The extent and manner in which simulation is used within Neonatal Resuscitation Program (NRP) courses across Canada is ...currently unknown. In order to improve NRP education, current practices must be better understood.
OBJECTIVES: To characterize current practices and use of simulation in NRP courses across Canada.
DESIGN/METHODS: A REDCap survey, consisting of questions about instructor demographics, practices in NRP instruction and use of simulation, was developed and distributed to all NRP instructors across Canada. Simple statistics were used to tabulate responses and the chi-squared test was used to assess differences in simulation use between different types of instructors.
RESULTS: Five hundred sixty nine of 1390 (40.9%) NRP instructors completed the survey. Participants included 88 (15.5%) physicians, 74 (13.0%) respiratory therapists, 345 (60.6%) registered nurses and 28 (4.9%) nurse practitioners. Two hundred fifty eight (45.4%) worked in institutions providing Level III care. Overall, 560 (98.4%) respondents used simulation, of which only 176 (31.4%) reported using high-technology simulation. Only 180 (31.6%) instructors who used simulation reported having received formal training in high-technology simulation. When asked about the role of simulation in NRP instruction, 545 (95.8%) agreed or strongly agreed that simulation is a valuable educational tool in NRP instruction, but only 219 (39.1%) felt comfortable using high-technology simulation. There was no difference in use of high-technology simulation between physician and non-physician instructors (I2 0.90, p=0.34). Of the instructors who used high-technology simulation, 160 (90.9%) and 134 (76.1%) had learners and instructors, respectively, from multiple healthcare disciplines present in some or all sessions. There was a non-significant trend towards higher use of interprofessional learners among physician instructors (I2 3.8, p=0.052). An impressive 554 (98.9%) debriefed after some or all simulation sessions, with only 295 (51.8%) instructors having received formal training in debriefing techniques.
CONCLUSION: Almost all NRP instructors use simulation and feel that it is valuable, though few have received formal training and feel comfortable using high-technology simulation. Most simulation use is low-technology, in keeping with the Canadian Paediatric Society (CPS) recommendations, though the optimal methods of use of simulation in NRP instruction are not known. The majority of instructors debrief with learners, as recommended by the CPS, though only half have had training in debriefing. The results of this study support further investigation into the optimal type of simulation in NRP teaching and more formal education in simulation and debriefing for NRP instructors.
The relationship between blood lead level and neurodevelopment was assessed in a pilot cross-sectional study of 74 4-14-year-old children in Chennai, India. Mean blood lead level was 11.1 microg/dL ...(2.5-38.3). The Binet-Kamath IQ test and the Wide Range Assessment of Visual Motor Activity (WRAVMA) were administered to 58 children. Teachers completed the Connor's Behavioral Rating Scale. Excluding two outliers, IQ and WRAVMA composite scores were inversely related to blood lead level, with an effect size of approximately 6 points decline for a 10-microg/dL increase in blood lead. Children in the highest and lowest blood lead quartiles had mean IQs of 95.6+/-13.3 and 102.0+/-22.5, respectively. Behavior ratings were not associated with blood lead level. Lead exposure is a significant problem among Indian children, with many having blood lead levels associated with increased neurodevelopmental risk.
