Background Bloodstream infection is associated with high mortality and serious morbidity in preterm babies. Evidence from clinical trials shows that antimicrobial-impregnated central venous catheters (CVCs) reduce catheterrelated bloodstream infection in adults and children receiving intensive care, but there is a paucity of similar evidence for babies receiving neonatal intensive care. Methods This open-label, parallel-group, pragmatic, randomised controlled trial was done in 18 neonatal intensive care units in England. Newborn babies who needed a peripherally inserted CVC (PICC) were allocated randomly (1:1) to receive either a PICC impregnated with miconazole and rifampicin or a standard (non-antimicrobial-impregnated) PICC. Random allocation was done with a web-based program, which was centrally controlled to ensure allocation concealment. Randomisation sequences were computer-generated in random blocks of two and four, and stratified by site. Masking of clinicians to PICC allocation was impractical because rifampicin caused brown staining of the antimicrobial-impregnated PICC. However, participant inclusion in analyses and occurrence of outcome events were determined following an analysis plan that was specified before individuals saw the unblinded data. The primary outcome was the time from random allocation to first microbiologically confirmed bloodstream or cerebrospinal fluid (CSF) infection between 24 h after randomisation and 48 h after PICC removal or death. We analysed outcome data according to the intention-to-treat principle. We excluded babies for whom a PICC was not inserted from safety analyses, as these analyses were done with groups defined by the PICC used. This trial is registered with ISRCTN, number 81931394. Findings Between Aug 12, 2015, and Jan 11, 2017, we randomly assigned 861 babies (754 [88%] born before 32 weeks of gestation) to receive an antimicrobial-impregnated PICC (430 babies) or standard PICC (431 babies). The median time to PICC removal was 8•20 days (IQR 4•77-12•13) in the antimicrobial-impregnated PICC group versus 7•86 days (5•00-12•53) days in the standard PICC group (hazard ratio [HR] 1•03, 95% CI 0•89-1•18, p=0•73), with 46 (11%) of 430 babies versus 44 (10%) of 431 babies having a microbiologically confirmed bloodstream or CSF infection. The time from random allocation to first bloodstream or CSF infection was similar between the two groups (HR 1•11, 95% CI 0•73-1•67, p=0•63). Secondary outcomes relating to infection, rifampicin resistance in positive blood or CSF cultures, mortality, clinical outcomes at neonatal unit discharge, and time to PICC removal were similar between the two groups, although rifampicin resistance in positive cultures of PICC tips was higher in the antimicrobial-impregnated PICC group (relative risk 3•51, 95% CI 1•16-10•57, p=0•018). 60 adverse events were reported from 49 (13%) patients in the antimicrobial-impregnated PICC group and 50 events from 45 (10%) babies in the standard PICC group. Interpretation We found no evidence of benefit or ha...
Fungal organisms pose a life-threatening risk to vulnerable premature infants. In this review, all cases of fungal sepsis in a large tertiary neonatal unit over the last 10 years (2008-2018) in premature neonates (<30 weeks gestation) were reviewed. This time frame spanned a change in prophylaxis policy from fluconazole to nystatin in 2012. The most common fungal organism causing sepsis was Candida albicans in 80% of cases and Candida parapsilosis in 13%. All fungal organisms cultured were fully sensitive; no resistant cases were seen in the last 10 years. Encouragingly, rates of infection were static (between 0 and 3 cases/year) over the last 10 years, despite the unit’s policy for antifungal prophylaxis changing from fluconazole to nystatin in 2012.
Objective: To assess agreement between transcutaneous carbon dioxide (TcCO2) monitoring and blood gas analysis in neonates. Study Design: This was a prospective observational study performed in a tertiary neonatal intensive care unit. 19 infants with a mean postmenstrual age of 35+3 weeks were included. Agreement was assessed by Bland-Altman analysis and concordance correlation coefficient. End-user feedback was collected from staff and infants were assessed for evidence of skin damage. Results: Overall bias from 698 paired samples was -0.30 (SD 1.21, p<0.0001) with good concordance (CCC 0.80). 69% (95% CI 65%-72%, p=0.0003) of samples fell within the predefined clinically acceptable difference of 1kPa. Agreement was more favorable for non-invasively ventilated infants (bias -0.11, CCC 0.91). Staff feedback was positive, and no infants suffered skin damage. Conclusion: TcCO2 monitoring is a reliable assessment tool for both invasively and non-invasively ventilated neonates. It can be used as an adjunct to blood gas analysis, reducing the frequency of invasive blood tests.
Aims The role of behavioural skills in the provision of safe and effective neonatal care is well recognised.1 Behaviour Assessment Tool (BAT) has been validated for use in simulated neonatal and paediatric environment to assess resuscitation skills.2 The aim of this study was to develop a modified version of the tool and validate it to assess trainee’s performance in stabilising an acutely unwell newborn. Methods Ethical approval was gained to study the performance of paediatric trainees. The modified Delphi method was used to develop a weighted scoring tool. Video recording of the performance of two trainees was used to train four assessors in use of the tool. Performance of a further sixteen trainees was recorded and was assessed by these assessors. Assessors were blinded to trainee’s identity and their years of experience. Results The scoring tool showed good interrater reliability (ICC = 0.80, CI: 0.58 – 0.92). Mean of the scores achieved by junior trainees was 34.03 (±5.42) compared to senior trainees 38.84 (±1.71). Results of the Independent Samples Mann-Whitney U Test demonstrated a statistically significant difference (P = 0.015) in the distribution of scores achieved by junior and senior trainees. Discussion The study demonstrates that reliable and valid measurements of behavioural skills can be obtained from simulated neonatal environments using this scoring tool. It is recognised that human factors such as lack of clear leadership, teamwork and communication rather than technical failures represent the greatest threat to complex systems like healthcare.3 In order to provide robust feedback and training in this area, it is important to have tools to assess behavioural skills in a valid and reliable manner. We feel that our tool can help to assess doctors in training and support the development of a robust training programme for the doctors of the future. References The Joint Comission. Sentinel event alert. Preventing infant death and injury during delivery. Adv Neonatal Care 2004;4:180–1 Anderson JM, Yaeger KA. The development of a behavioral scoring tool for neonatal resuscitation. In: Society for Medical Simulation Meeting. San Diego, CA. 2006. Reason J. Understanding adverse events: human factors. Qual Health Care 1995;4:80–9
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