Effect of Serial Clinical Observation Complemented by Point-of-Care Blood Culture Volume Verification on Antibiotic Exposure in Newborns.

Objective. This study evaluated the effects of serial clinical observation strategy complemented by point-of-care verification of blood culture volume in managing term and near-term newborns at risk for early-onset sepsis. Methods. We used a "before-and-after" approach. Infants born at ≥35 0/7 weeks' gestation were eligible. Our strategy was based on serial clinical observation complemented with point-of-care verification of blood culture volume. Two separate 12-month periods were analyzed. The number of infants exposed to antibiotics started during the first 3 days of life was compared before and after introducing the strategy. Results. During the post-intervention period, 0.6% of infants received antibiotic therapy, compared to 4.1% during the pre-intervention period (P < .001; relative risk [RR]: 0.15; 95% CI: 0.08-0.28). Conclusion. Serial clinical observation complemented with verification of blood culture volume might reduce antibiotic utilization in newborns in the early postnatal period.

Point-of-Care Verification of Blood Culture Volume in Neonates: A Feasibility Trial.

BACKGROUND: Blood cultures remain the gold standard for the diagnosis of sepsis. However, volumes of blood submitted for cultures often do not match the recommended values. We propose a simple intervention aimed to verify the volume of blood sampled using a scale. This study was undertaken in preparation for a future, multicenter, pre- and post-intervention trial. Our primary objective was to test the feasibility (uptake and retention) of this future intervention. MATERIALS AND METHODS: This study was conducted at a neonatal department in Warsaw, Poland, over a period of eight months (May to December 2020). Before starting the study, we undertook an educational intervention focused on obtaining adequate blood volumes for culture. The culture bottles that were weighed in advance were distributed in all blood collection areas. Blood volume was verified by weighing the bottle immediately after blood inoculation. The calculated value was communicated to the collecting clinician and recorded. The primary outcome measure was the percentage of blood culture submissions for which the blood volume inoculated into the bottles was determined by weighing. RESULTS: During the study period, 244 blood samples were collected for culture, out of which 205 samples were weighed (84.0%, CI95 [78.8% to 88.4%]). This high proportion remained stable throughout the study period. We have not observed any adverse events related to the study. CONCLUSIONS: The point-of-care verification of blood culture volume using a scale was feasible to implement. Since we have met our pre-established criterion for success, a future, definitive trial is likely to proceed.

Effects of Early versus Standard Central Line Removal on the Growth of Preterm Infants with Very Low Birth Weight: A Non-Inferiority, Randomized Clinical Trial.

Very preterm infants are usually supported by parenteral nutrition delivered through central lines (CLs) while progressing with enteral intake, although the optimal time point for their removal is unclear. This study evaluated the impact of the CL discontinuation time on the short-term growth outcomes of preterm infants. A non-inferiority, parallel-group, randomized controlled trial was conducted in four neonatal intensive care units in Poland. Preterm infants with very low birth weight (VLBW) without congenital abnormalities were eligible. Patients were allocated to discontinue central access at an enteral feeding volume of 100 mL/kg/day (intervention group) or 140 mL/kg/day (control group). The study's primary outcome was weight at 36 weeks' postmenstrual age, with a non-inferiority margin of -210 g. Overall, 211 patients were allocated to the intervention or control groups between January 2019 and February 2021, of which 101 and 100 were eligible for intention-to-treat analysis, respectively. The mean weight was 2232 g and 2200 g at 36 weeks' postmenstrual age in the intervention and control groups, respectively. The mean between-group difference was 32 g (95% confidence interval, -68 to 132; p = 0.531), which did not cross the specified margin of non-inferiority. No intervention-related adverse events were observed. Early CL removal was non-inferior to the standard type for short-term growth outcomes in VLBW infants.

Effect of early versus standard central line removal on growth of very low birthweight premature infants: a protocol for a non-inferiority randomised controlled trial.

INTRODUCTION: Uncertainty exists regarding the optimal time for removal of central lines used to provide parenteral nutrition in preterm infants. The aim of this study is to determine whether earlier central line removal is non-inferior to its removal after reaching full enteral intake, in respect to growth outcome of preterm infants. METHODS AND ANALYSIS: Very low birthweight premature infants will be recruited. Eligible infants will be randomised in equal proportions between two groups. In the intervention group central lines will be removed when infants reach 100 mL/kg/day of enteral intake. In the control group central lines will be removed when infants reach 140 mL/kg/day of enteral intake (full enteral intake). The primary outcome measure will be the difference between the two groups in weight at 36 weeks' postmenstrual age. Non-inferiority will be declared if the mean weight of children in the intervention group will be no worse than the mean weight of children from the control group, by a margin of -210 g. ETHICS AND DISSEMINATION: The Bioethics Committee of the Medical University of Warsaw approved the study protocol prior to recruitment. The findings of this trial will be submitted to a peer-reviewed journal (neonatology, paediatrics or nutrition). Abstracts will be submitted to relevant national and international conferences. TRIAL REGISTRATION NUMBER: NCT03730883. PROTOCOL VERSION: Version 3. 14.08.2019.

Should empiric antibiotic therapy be withheld when aetiology of preterm birth is non-infectious? A protocol for a systematic review.

INTRODUCTION: Preterm birth (PTB) at <37 weeks of gestation is the leading cause of perinatal morbidity and mortality in developed countries. The traditional approach has been based on the assumption that PTB is primarily a result of intrauterine infection, which triggers preterm labour and puts the newborn at risk of early onset sepsis (EOS). We are currently experiencing a rise in prematurity that results from maternal and fetal diseases unrelated to infection. We have designed a systematic review to assess whether chemoprophylaxis should be withheld when the aetiology of preterm birth is non-infectious. METHODS AND ANALYSIS: Our study will focus on studies evaluating EOS in preterm infants. We will conduct a comprehensive search of literature available up to 28 February 2018. An information specialist will search for eligible studies in Medline (Ovid interface, 1948 and onwards), Embase (Ovid interface, 1980 onwards) and the Cochrane Central Register of Controlled Trials (Wiley interface, current issue). We will search databases and registries including records of ongoing research, conference proceedings and thesis (clinical trials, WHO International Clinical Trials Registry Platform). Two authors will independently extract data from eligible studies and assess risk of bias. For continuous outcomes, which follow discrete distribution, mean difference will be calculated. Dichotomous data will be presented using risk ratios, while count data will be expressed using rate ratios. Time-to-event outcomes will be reported as HRs. All estimates will be presented together with 95% CI. Studies comparable with respect to methodology and reporting the same outcomes will be combined in a meta-analysis. ETHICS AND DISSEMINATION: Our systematic review does not require approval from the research and ethics board. We will use the findings to prepare a future multicentre randomised control trial in order to establish safe and adequate antibiotics policies for preterm infants, based on the aetiology of PTB. PROSPERO REGISTRATION NUMBER: CRD42016029707.