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.
Objective
To perform a temporal and geographical validation of a prognostic model, considered of highest methodological quality in a recently published systematic review, for predicting survival in ...very preterm infants admitted to the neonatal intensive care unit. The original model was developed in the UK and included gestational age, birthweight and gender.
Design
External validation study in a population‐based cohort.
Setting
Dutch neonatal wards.
Population or sample
All admitted white, singleton infants born between 23+0 and 32+6 weeks of gestation between 1 January 2015 and 31 December 2019. Additionally, the model’s performance was assessed in four populations of admitted infants born between 24+0 and 31+6 weeks of gestation: white singletons, non‐white singletons, all singletons and all multiples.
Methods
The original model was applied in all five validation sets. Model performance was assessed in terms of calibration and discrimination and, if indicated, it was updated.
Main outcome measures
Calibration (calibration‐in‐the‐large and calibration slope) and discrimination (c statistic).
Results
Out of 6092 infants, 5659 (92.9%) survived. The model showed good external validity as indicated by good discrimination (c statistic 0.82, 95% CI 0.79–0.84) and calibration (calibration‐in‐the‐large 0.003, calibration slope 0.92, 95% CI 0.84–1.00). The model also showed good external validity in the other singleton populations, but required a small intercept update in the multiples population.
Conclusions
A high‐quality prognostic model predicting survival in very preterm infants had good external validity in an independent, nationwide cohort. The accurate performance of the model indicates that after impact assessment, implementation of the model in clinical practice in the neonatal intensive care unit could be considered.
Tweetable
A high‐quality model predicting survival in very preterm infants is externally valid in an independent cohort.
Tweetable
A high‐quality model predicting survival in very preterm infants is externally valid in an independent cohort.
Linked article This article is commented on by EM McClure & RL Goldenberg pp. 539 in this issue. To view this minicommentary visit https://doi.org/10.1111/1471-0528.17014.
In many paediatric intensive care units (PI-CUs) chest X-ray films (CXRs) are required as part of the daily examination or after completion of invasive procedures.
First, to evaluate if the American ...College of Radiology (ACR) guidelines for adult patients are appropriate for paediatric patients. Second, to assess the diagnostic efficacy of the CXRs.
One-hundred-seventy-four CXRs acquired in 74 patients, either routinely or after invasive procedures, were analysed. The indication of the obtained CXRs, or the absence of indication in patients in whom no CXRs was taken, was compared with ACR guidelines. The position of medical devices was evaluated. Changes in cardiopulmonary status were noted.
Sixty-seven percent of the CXRs were in accordance with the ACR guidelines, and in 74% of patients in whom no CXRs were taken this was also in accordance with these guidelines. Sixteen percent of the endotracheal tubes, 23% of central venous lines and 15% of nasogastric tubes were malpositioned. Changes in cardiopulmonary status, after the initial film, were noted in 63%.
The indications for the majority of CXRs in our PICU appeared to be in accordance with ACR guidelines. The high percentage of malpositioned tubes and lines and the number of cardiopulmonary changes on CXRs in a PICU underline the value of these films. Adjustments of the ACR guidelines for particular groups of paediatric patients may limit the number of CXRs taken and may further increase diagnostic efficacy.
