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Antibiotic exposure at the beginning of life can lead to increased antimicrobial resistance and perturbations of the developing microbiome. Early-life microbiome disruption increases the risks of developing chronic diseases later in life. Fear of missing evolving neonatal sepsis is the key driver for antibiotic overtreatment early in life. Bias (a systemic deviation towards overtreatment) and noise (a random scatter) affect the decision-making process. In this perspective, we advocate for a factual approach quantifying the burden of treatment in relation to the burden of disease balancing antimicrobial stewardship and effective sepsis management. Fear of missing neonatal sepsis has led to early in life antibiotic administration, even without culture-proven sepsis. Here, the authors discuss the potential impact on antimicrobial resistance, and chronic disease later in life, due to effect on the developing microbiome, suggesting a factual based approach in quantifying burden of treatment in relation to the burden of disease.

ObjectiveTo investigate the mental health of children and adolescents admitted to neonatal intensive/special care units (NICUs) in infancy.MethodsThis cross-sectional study used a provincially representative cohort from the 2014 Ontario Child Health Study. Parents provided data on psychiatric disorders using the MINI International Neuropsychiatric Interview for Children and Adolescents in 3141 children aged 4–11 years (NICU n=389; control n=2752) and in 2379 children aged 12–17 years (NICU n=298; control n=2081). Additionally, 2235 adolescents aged 12–17 years completed the interview themselves (NICU n=285; control n=1950). Odds of psychiatric disorder were compared in those admitted and controls.ResultsBased on parent reports, NICU graduates aged 4–11 years had increased adjusted ORs (95% CI) of 1.78 (1.39 to 2.28) for any psychiatric disorder, with a marginal prevalence of 32.4% in NICU participants and 27.6% in controls. At this age, NICU graduates also had increased ORs of 1.74 (1.25 to 2.40) for psychiatric comorbidity, 1.48 (1.04 to 2.11) for oppositional defiant disorder, 1.61 (1.19 to 2.19) for attention-deficit hyperactivity disorder, 4.11 (2.33 to 7.25) for separation anxiety disorder and 2.13 (1.37 to 3.31) for specific phobia. At 12–17 years, 40.5% and 30.5% of NICU graduates and 30.6% and 17.9% of controls had any psychiatric disorder as reported by parents and self-report, respectively. Parents and adolescents, respectively, reported increased adjusted ORs (95% CI) of 1.63 (1.18 to 2.26) and 1.55 (1.13 to 2.11) for any disorder, 1.64 (1.06 to 2.54) and 1.74 (1.11 to 2.73) for psychiatric comorbidity, and 1.89 (1.22 to 2.93) and 3.17 (2.03 to 4.95) for oppositional defiant disorder.ConclusionsNICU graduates are at increased risk for psychiatric disorders during childhood and adolescence.

PurposeThis paper aims to examine the experiences of diverse interprofessional participants in an Equity, Diversity and Inclusion (EDI) working group with a common interest in EDI in one of the largest pediatric teaching hospitals in Canada and how the impacts of this experience extend outside of the group.Design/methodology/approachThis qualitative research utilized an inductive approach in line with the Gioia methodology (Gioia et al., 2013) to explore individual experiences as participants in an EDI working group. Seven group members were interviewed in-depth and engaged in storytelling and journaling to capture their experiences and perspectives. The perspectives of six members are reflected here, representing diversity across ethnicity, professions and subjective experiences, with a common interest in working together to improve EDI knowledge dissemination, training and practice in a healthcare setting in Canada.FindingsRetrospective research activities facilitated a co-constructed account. The analysis reveals that EDI group participation is a positive learning experience for individuals described as thriving in their careers. Analysis of collaborative perspectives emphasizes how collective identity cultivates vitality in the EDI group environment. EDI group members exhibit agency as proponents of social change, navigating and negotiating institutional norms in varying professional spaces.Research limitations/implicationsThe participants included members of an EDI working group in healthcare. Six perspectives are reflected here. Implications for personal experience and career development in organizations are discussed.Originality/valueThis study contributes to understanding how participating in specific interest groups, such as a group focused on EDI, informs personal and career development. It also contributes to our understanding of intrinsic motivation, as evidenced among volunteers in this healthcare setting. Our study also depicts an environment of vitality and learning and that collective thriving can be produced and may have extra-role implications.

Background/Objectives: Preterm infants are at high risk of extrauterine growth restriction and suboptimal neurological development due to cumulative nutrient deficits. Standard fortification (SF) of human milk does not account for individual macronutrient variability, potentially leading to inadequate intake. Target fortification (TFO) adjusts supplementation based on the measured macronutrient content, aimed at providing macronutrient intake aligned with ESPGHAN (European Society for Paediatric Gastroenterology, Hepatology and Nutrition) recommendations and optimize growth and development. This study aims to evaluate the effects of TFO compared to SF on growth, body composition, and neurological outcomes at 18 months corrected age. Methods: In this double-blind, randomized controlled trial, preterm infants (<30 weeks gestation) received either SF or TFO for at least three weeks. Macronutrient levels in breast milk were analyzed three times per week, with modular adjustments in the TFO group. Growth parameters, body composition at 36 weeks postmenstrual age, and Bayley Scales of Infant and Toddler Development III (BSID-III) scores at 18 months corrected age were assessed (n = 69). Results: TFO significantly increased protein, fat, and carbohydrate intake compared to SF, leading to higher weight gain (2514 ± 289 g vs. 2283 ± 332 g, p < 0.01) and growth velocity (21.7 ± 2.3 g/kg/d vs. 19.2 ± 2.2 g/kg/d, p < 0.001). In infants whose mother’s milk had low protein levels, fat-free mass was significantly higher with TFO compared to SF. BSID-III scores were higher in the TFO group across cognitive, language, and motor domains, with significant improvements in expressive language scores in infants whose mother’s milk had high protein levels (p < 0.05). The number of preterm infants with a motor BSID-III score of ≤70 was significantly lower in the TFO group compared to the SF group (0 vs. 3, p < 0.05). Conclusions: TFO enhanced growth and body composition and may support better neurological outcomes in preterm infants. While most BSID-III differences were not statistically significant, the data suggest that TFO may reduce the risk of developmental delays. Larger, multicenter trials are needed to confirm these findings.

Background: Diagnosis of neonatal early-onset sepsis is difficult because clinical signs and laboratory tests are non-specific. Early antibiotic therapy is crucial for treatment success. Objective: To evaluate the effect of procalcitonin (PCT)-guided decision-making on duration of antibiotic therapy in suspected neonatal early-onset sepsis. Methods: This single-center, prospective, randomized intervention study was conducted in a tertiary neonatal and pediatric intensive care unit in the Children’s Hospital of Lucerne, Switzerland, between June 1, 2005 and December 31, 2006. All term and near-term infants (gestational age ≧34 weeks) with suspected early-onset sepsis were randomly assigned either to standard treatment based on conventional laboratory parameters (standard group) or to PCT-guided treatment (PCT group). Minimum duration of antibiotic therapy was 48–72 h in the standard group, whereas in the PCT group antibiotic therapy was discontinued when two consecutive PCT values were below predefined age-adjusted cut-off values. Results: 121 newborns were randomly assigned either to the standard group (n = 61) or the PCT group (n = 60). The two groups were similar for baseline demographics, risk factors for early-onset sepsis, likelihood of infection as assessed by the attending physician and early conventional laboratory findings. There was a significant difference in the proportion of newborns treated with antibiotics ≧72 h between the standard group (82%) and the PCT group (55%) (absolute risk reduction 27%; odds ratio 0.27 (95% CI 0.12–0.62), p = 0.002). On average, PCT-guided decision-making resulted in a shortening of 22.4 h of antibiotic therapy. Clinical outcome was similar and favorable in both groups but sample size was insufficient to exclude rare adverse events. Conclusion:Serial PCT determinations allow to shorten the duration of antibiotic therapy in term and near-term infants with suspected early-onset sepsis. Before this PCT-guided strategy can be recommended, its safety has to be confirmed in a larger cohort of neonates.

BackgroundHealthcare organisations face widespread challenges in optimising their safety culture, especially amid conflicting stakeholder needs, staffing shortages and increasing acuity of patients. McMaster University Children’s Hospital Neonatal Intensive Care Unit developed a safety culture programme that prioritises the needs of patients, hospital staff and learners altogether.MethodsThe safety culture programme and activities revolve around six primary drivers: psychological safety, provider well-being, equity, diversity and inclusion, teamwork and communication, organisational learning and leadership. We describe how these drivers influence safety culture, the ongoing activities being implemented, stakeholder feedback and contextual factors. We evaluated the maturity of our safety culture using the Manchester Patient Safety Framework (MaPSaF) questionnaire.ResultsMaPSaF assessments were conducted three times over 4 years. Most domains of safety culture in MaPSaF maintained their position despite COVID-19 while some indicators declined or have been maintained.ConclusionsWe provide a framework for implementing a safety culture programme that addresses the needs of diverse stakeholders. Transformation of the safety culture takes time and the failure to improve the patient safety measures over the period may be attributed to rapidly increasing workload and worsening patient acuity. These challenges underscore the imperative of balancing transactional and transformational projects to preserve a safety culture.

PurposeRemote ischemic conditioning (RIC) is a maneuver involving brief cycles of ischemia reperfusion in an individual’s limb. In the early stage of experimental NEC, RIC decreased intestinal injury and prolonged survival by counteracting the derangements in intestinal microcirculation. A single-center phase I study demonstrated that the performance of RIC was safe in neonates with NEC. The aim of this phase II RCT was to evaluate the safety and feasibility of RIC, to identify challenges in recruitment, retainment, and to inform a phase III RCT to evaluate efficacy.MethodsRIC will be performed by trained research personnel and will consist of four cycles of limb ischemia (4-min via cuff inflation) followed by reperfusion (4-min via cuff deflation), repeated on two consecutive days post randomization. The primary endpoint of this RCT is feasibility and acceptability of recruiting and randomizing neonates within 24 h from NEC diagnosis as well as masking and completing the RIC intervention.ResultsWe created a novel international consortium for this trial and created a consensus on the diagnostic criteria for NEC and protocol for the trial. The phase II multicenter-masked feasibility RCT will be conducted at 12 centers in Canada, USA, Sweden, The Netherlands, UK, and Spain. The inclusion criteria are: gestational age < 33 weeks, weight ≥ 750 g, NEC receiving medical treatment, and diagnosis established within previous 24 h. Neonates will be randomized to RIC (intervention) or no-RIC (control) and will continue to receive standard management of NEC. We expect to recruit and randomize 40% of eligible patients in the collaborating centers (78 patients; 39/arm) in 30 months. Bayesian methods will be used to combine uninformative prior distributions with the corresponding observed proportions from this trial to determine posterior distributions for parameters of feasibility.ConclusionsThe newly established NEC consortium has generated novel data on NEC diagnosis and defined the feasibility parameters for the introduction of a novel treatment in NEC. This phase II RCT will inform a future phase III RCT to evaluate the efficacy and safety of RIC in early-stage NEC.

Background Late-onset infections (LOI) are a major cause of morbidity and mortality among patients in the neonatal intensive care unit (NICU). Gloving after hand hygiene may be a pragmatic approach to prevent infections that arise when healthcare workers’ hands transmit pathogens to neonates. Objective To determine the feasibility of conducting a multicenter, open-labeled randomized controlled trial (RCT) to determine whether a protocol that requires healthcare workers (HCWs) in a level 3 NICU to wear non-sterile gloves plus hand hygiene reduces the occurrence of a late-onset infection, compared to hand hygiene alone. Methods In this single-center pilot study, we recruited neonates admitted to the McMaster Children’s Hospital NICU from June 2017 to May 2018. The NICU was randomized to begin with the standard (control) arm for 6 months (June 2017 to Dec 2017), followed by the gloving (GloveCare) arm for 6 months (Jan 2018 to July 2018), with a 2-week washout period in-between to educate healthcare workers about gloving. We measured numerous feasibility outcomes including enrollment, event rate, and compliance with hand hygiene (Moment 1: before patient contact, Moment 2: before clean procedure, Moment 3: after body fluid contact, Moment 4: after patient contact) and gloving compliance. Results We enrolled 750 neonates (390 Standard care, 360 GloveCare) and achieved 100% enrollment. We found higher hand hygiene compliance during the standard care arm compared to the GloveCare for all four moments of hand hygiene (Moment 1: 87% vs 79%, OR=1.86 (1.34, 2.59); Moment 2: OR=1.73 (1.00, 3.01); Moment 3: OR=1.11 (0.62, 1.98); Moment 4: OR=1.65 (1.27, 2.14)). We developed and validated a method to calculate glove compliance, which ranged from 48 to 85%, and was highest for moment 3 (doffing after a procedure or body fluid exposure risk). No adverse events were documented for patients or staff. Discussion Reduction in hand hygiene compliance in the GloveCare arm presents a pragmatic challenge in ascertaining the effectiveness of gloving to prevent LOI. Most LOIs were non-sterile-site infections, which is considered a less patient-important or clinically relevant outcome compared to sterile-site LOI. Ensuring efficient collection and validation of hand hygiene and gloving data is imperative. Conclusion The pilot study demonstrated the feasibility of this intervention though modifications to improve hand hygiene compliance during GloveCare will be important prior to a multicenter cluster RCT to assess the efficacy of non-sterile glove-based care in preventing LOI in the NICU. Trial registration Clinicaltrials.gov, NCT03078335

IntroductionQuality improvement (QI) is a growing field of inquiry in healthcare, including neonatology. However, there is limited information on the study setting, and the methodologic approaches used to develop, implement and evaluate QI interventions in neonatology studies. In this study, we describe these intervention characteristics and approaches.MethodsArticles were taken from a previous publication. There, we searched MEDLINE for publications of QI studies from 2016 to 16 April 2020. We retrieved all relevant full-text publications and sampled 100 of these articles for data abstraction, stratified by the year of publication. For each QI study, we described several methodological characteristics that included: the clinical topic of QI, setting, whether the study was multicentre, stakeholder engagement, root cause analysis and related problem identification methods, implementation techniques for QI interventions, types of outcomes and statistical analysis methods used.ResultsWe assessed 100 studies; most were conducted in the USA (56%). Academic settings and multicentre settings comprised 44% and 24% of studies, respectively. Most studies reported stakeholder engagement (81%), but infrequently reported engagement with leadership (32%) and caregivers (10%). Frequently used techniques for implementing interventions include provider education (82%), formal QI methods (42%) and audit, feedback and benchmarking (40%). Both patient-important clinical outcomes (78%) and process outcomes (89%) were frequently reported. P values were frequently reported (80%), but other statistical techniques were infrequently used.ConclusionQI studies in neonatology use diverse multicomponent interventions. Reporting of these methodologic details can be useful in designing, implementing and evaluating QI studies in clinical practice.

IntroductionQuality improvement (QI) is a growing field of inquiry in healthcare, but the reporting quality of QI studies in neonatology remains unclear. We conducted a systematic survey of the literature to assess the reporting quality of QI studies and factors associated with reporting quality.MethodsWe searched Medline for publications of QI studies from 2016 to 16 April 2020. Pairs of reviewers independently screened citations and assessed reporting quality using a 31-item modified Standards for Quality Improvement Reporting Excellence, 2nd edition (SQUIRE 2.0) checklist. We reported the number (percentage) of studies that reported each item and their corresponding 95% CIs. We used Poisson regression to explore factors associated with reporting quality, namely, journal endorsement of SQUIRE 2.0, declaration of funding sources, year of publication and number of authors. The results were reported as incidence rate ratio (IRR) and 95% CI.ResultsOf 1921 citations, 336 were eligible; among them, we randomly selected 100 articles to assess reporting quality. The mean (standard deviation) number of SQUIRE 2.0 items adhered to was 22.0 (4.5). Percentage of articles reporting each item varied from 26% to 100%. Journal endorsement of SQUIRE 2.0 (IRR=1.11, 95% CI 1.02 to 1.21, p=0.015), declaration of funding sources and increasing number of authors were significantly associated with better reporting.ConclusionsReporting quality of QI studies in neonatology is inadequate. Endorsing the SQUIRE 2.0 guideline is a step that journals can implement to enhance the completeness of reporting.