Meconium Concentrations of Pesticides and Risk of Hypospadias: A Case-Control Study in Brittany, France.

BACKGROUND: Hypospadias is a male genital tract defect for which an increase in prevalence has been documented over the last few decades. A role for environmental risk factors is suspected, including prenatal exposure to pesticides. OBJECTIVES: To study the risk of hypospadias in association with multiple pesticide measurements in meconium samples. METHODS: The Brittany Registry of Congenital Anomalies (France) conducted a case-control study between 2012 and 2018. Cases were hypospadias, ascertained by a pediatrician and a pediatric surgeon, excluding genetic conditions, following European Surveillance of Congenital Anomalies guidelines (N = 69). Controls (N = 135) were two male infants without congenital anomaly born after each case in the same maternity unit. Mothers in the maternity units completed a self-administered questionnaire, we collected medical data from hospital records, and medical staff collected meconium samples. We performed chemical analysis of 38 pesticides (parent compound and/or metabolite) by UHPLC/MS/MS following strict quality assurance/quality control criteria and blind to case-control status. We carried out logistic regression accounting for frequency-matching variables and major risk factors. RESULTS: Among the 38 pesticides measured, 16 (42%) were never detected in the meconium samples, 18 (47%) were in <5% of samples, and 4 (11%) in ≥5% of the samples. We observed an association between the detection of fenitrothion in meconium and the risk of hypospadias (OR = 2.6 [1.0-6.3] with n cases = 13, n controls = 21), but not the other pesticides. CONCLUSIONS: Our small study provides a robust assessment of fetal exposure. Fenitrothion's established antiandrogenic activities provide biologic plausibility for our observations. Further studies are needed to confirm this hypothesis.

Early exposure to mercury and cardiovascular function of seven-year old children in Guadeloupe (French West Indies).

BACKGROUND: The cardiotoxicity of prenatal exposure to mercury has been suggested in populations having regular contaminated seafood intake, though replications in the literature are inconsistent. METHODS: The Timoun Mother-Child Cohort Study was set up in Guadeloupe, an island in the Caribbean Sea where seafood consumption is regular. At seven years of age, 592 children underwent a medical examination, including cardiac function assessment. Blood pressure (BP) was taken using an automated blood pressure monitor, heart rate variability (HRV, 9 parameters) and electrocardiogram (ECG) characteristics (QT, T-wave parameters) were measured using Holter cardiac monitoring during the examination. Total mercury concentrations were measured in cord blood at birth (median = 6.6 µg/L, N = 399) and in the children's blood at age 7 (median = 1.7 µg/L, N = 310). Adjusted linear and non-linear modelling was used to study the association of each cardiac parameter with prenatal and childhood exposures. Sensitivity analyses included co-exposures to lead and cadmium, adjustment for maternal seafood consumption, selenium and polyunsaturated fatty acids (n3-PUFAs), and for sporting activity. RESULTS: Higher prenatal mercury was associated with higher systolic BP at 7 years of age (ßlog2 = 1.02; 95% Confidence Interval (CI) = 0.10, 1.19). In boys, intermediate prenatal exposure was associated with reduced overall HRV and parasympathetic activity, and longer QT was observed with increasing prenatal mercury (ßlog2 = 4.02; CI = 0.48, 7.56). In girls, HRV tended to increase linearly with prenatal exposure, and no association was observed with QT-wave related parameters. Mercury exposure at 7 years was associated with decreased BP in girls (ßlog2 = -1.13; CI = -2.22, -0.004 for diastolic BP). In boys, the low/high-frequency (LF/HF) ratio increased for intermediate levels of exposure. CONCLUSION: Our study suggests sex-specific and non-monotonic modifications in some cardiac health parameters following prenatal exposure to mercury in pre-pubertal children from an insular fish-consuming population.

Qualitative analysis of mothers' perception related to the delivery of information regarding preterm births.

BACKGROUND: Preterm birth is a major health issue due to its potential outcomes and socioeconomic impact. Prenatal counseling is of major importance for parents because it is believed that the risk of preterm birth is associated with a higher parental mental burden. Nowadays in France, the content and delivery of antenatal counseling is based on personal experience since there is a lack of official guidelines. The goal of the study was to evaluate maternal perception of antenatal information delivered in the setting of preterm births. METHODS: A qualitative study was performed using semi-structured individual interviews of 15 mothers with a child born > 26-34 GW. Data analysis was based on a constant comparative method. RESULTS: Concerning prenatal counseling content, parents wanted to be informed of their role in the care of their preterm child more so than statistics that were not always considered relevant. Parents' reactions to the announcement of the risk of a preterm birth was dominated by stupefaction, uncertainty and anxiety. When it comes to the setting of prenatal counseling, patients' room was deemed an appropriate setting by parents and ideally the presence of a coparent was appreciated as it increased patients' understanding. The physicians' attitude during the counseling was considered appropriate and described as empathic and optimistic. The importance of support throughout the hospitalization in the form of other parents' experiences, healthcare professionals and the possibility to preemptively visit the NICU was emphasized by participants. Delivery experience was dominated by a sense of uncertainty, and urgency. Some leads for improvement included additional support of information such as virtual NICU visit; participants also insisted on continuity of care and the multidisciplinary aspect of counseling (obstetrician, neonatologist, midwife, nurse, lactation consultant and psychologist). CONCLUSION: Highlighting parents' expectations about prenatal counseling could lead to the establishment of overall general guidelines. However, some topics like the use of statistics and mentioning the risk of death underline the importance of a personalized information.

Learning curves of novice residents on cataract surgery simulator: the E3CAPS pedagogic study.

INTRODUCTION: Training novice ophthalmology residents on the EyeSi® simulator increases cataract surgery safety. However, there is no consensus regarding how much training residents should perform before their first time on patients. We evaluated the French national training program through the analysis of the learning curves of novice residents. METHODS: This prospective multicentric pedagogic study was conducted with French novice residents. Each resident completed the recommended four two-hour training sessions and performed a standardized assessment simulating standard cataract surgery before the first session (A0), at the end of the first (A1), second (A2), third (A3) and fourth (A4) sessions. For each surgical step of each attempt, the following data were collected: score, odometer, completion time, posterior capsular rupture and cumulative energy delivered (ultrasounds) during phacoemulsification. A performance threshold was set at a score of 80/100 for each surgical step, 400/500 for the overall procedure. Only descriptive statistics were employed. RESULTS: Sixteen newly nominated ophthalmology residents were included. Median score progressively increased from 95 [IQR 53; 147]) at A0 to 425 [IQR 411; 451] at A4. Despite a significant progression, the "emulsification" step had the lowest A4 scores 86 [IQR 60; 94] without reduction in completion time, odometer or ultrasounds delivered. The rate of posterior capsular rupture decreased linearly from 75% at A0 to 13% at A4 during "emulsification" and from 69 to 0% during "irrigation and aspiration". At A4, only 25% [8; 53] of residents had > 80 at each step and only 75% [47; 92] had > 400/500 overall. CONCLUSION: A training program consisting of four two-hour sessions on the EyeSi simulator over four consecutive days effectively enhances the surgical skills of novice ophthalmology residents. Undergoing more training sessions may improve scores and decrease the incidence of surgical complications, particularly at the emulsification step of cataract surgery. The learning curves presented here can reassure residents who are progressing normally and help identify those who need a further personalized training program.  TRIAL REGISTRATION: ClinicalTrials registration number: NCT05722080 (first submitted 22/12/2022, first posted 10/02/2023).

Cardiorespiratory alterations in a newborn ovine model of systemic viral inflammation.

BACKGROUND: Respiratory viruses can be responsible for severe apneas and bradycardias in newborn infants. The link between systemic inflammation with viral sepsis and cardiorespiratory alterations remains poorly understood. We aimed to characterize these alterations by setting up a full-term newborn lamb model of systemic inflammation using polyinosinic:polycytidylic acid (Poly I:C). METHODS: Two 6-h polysomnographic recordings were carried out in eight lambs on two consecutive days, first after an IV saline injection, then after an IV injection of 300 µg/kg Poly I:C. RESULTS: Poly I:C injection decreased locomotor activity and increased NREM sleep. It also led to a biphasic increase in rectal temperature and heart rate. The latter was associated with an overall decrease in heart-rate variability, with no change in respiratory-rate variability. Lastly, brainstem inflammation was found in the areas of the cardiorespiratory control centers 6 h after Poly I:C injection. CONCLUSIONS: The alterations in heart-rate variability induced by Poly I:C injection may be, at least partly, of central origin. Meanwhile, the absence of alterations in respiratory-rate variability is intriguing and noteworthy. Although further studies are obviously needed, this might be a way to differentiate bacterial from viral sepsis in the neonatal period. IMPACT: Provides unique observations on the cardiorespiratory consequences of injecting Poly I:C in a full-term newborn lamb to mimic a systemic inflammation secondary to a viral sepsis. Poly I:C injection led to a biphasic increase in rectal temperature and heart rate associated with an overall decrease in heart-rate variability, with no change in respiratory-rate variability. Brainstem inflammation was found in the areas of the cardiorespiratory control centers.

Criteria for assessing the quality of clinical practice guidelines in paediatrics and neonatology: a mixed-method study.

BACKGROUND: Evidenced-based practice is a key component of quality care. This study aims to explore users' expectations concerning paediatric local clinical practice guidelines. METHODS: A mixed method approach was applied, including material from quantitative questionnaire and semi-structured interviews. Data were analysed using descriptive statistics and qualitative content analysis. Data were analysed with constant comparative method. Qualitative data were parsed and categorized to identify themes related to decision-making. RESULTS: A total of 83 physicians answered the survey (response rate 83%). 98% of the participants wanted protocols based on international guidelines, 80% expected a therapeutic content. 24 semi-structured interviews were conducted to understand implementation processes, barriers and facilitators. Qualitative analysis revealed 5 emerging themes: improvement of local clinical practice guidelines, patterns of usage, reasons for non-implementation, alternative sources and perspectives. CONCLUSION: Some criteria should be considered for the redaction of local clinical practice guidelines: focus on therapeutic, ease of access, establish local clinical practice guidelines based on international guidelines adapted to the local setting, document references and include trainees such as residents in the redaction.

Parents' and healthcare professionals' perceptions of the use of live video recording in neonatal units: a focus group study.

BACKGROUND: The emerging use of video in neonatology units raises ethical and practical questions. This study aims to gain a better understanding of the suitability, limitations and constraints concerning the use of live video as a tool in neonatal clinical practice. The perceptions of parents and healthcare professionals in regard to live video were examined. METHODS: Nine focus groups were conducted in four neonatal units involving 20 healthcare professionals and 19 parents. Data were triangulated using transcripts and field notes and analyzed using inductive and semantic thematic analysis. RESULTS: The seven major themes that emerged from the healthcare professionals focus groups were (i) the impact of video recording on healthcare professionals' behavior; (ii) the impact on parents; (iii) forensic issues;(iv) guarantee of use; (v) benefits for the newborn; (vi) methodology of use; and (vii) technical considerations & feasibility. The five major themes that emerged from parents focus groups were (i) benefits for the newborn and care enhancement; (ii) impact on parents and potential benefits in case of newborn child/parent separation; (iii) informed consent and guarantee of use;(iv) concern about a possible disruptive impact on healthcare professionals; and (v) data protection. CONCLUSION: Both parents and healthcare professionals found video recording useful and acceptable if measures were taken to protect the data and mitigate any negative impacts on healthcare professionals.

French neonatal society position paper stresses the importance of an early family-centred approach to discharging preterm infants from hospital.

AIM: The families of hospitalised preterm infants risk depression and post-traumatic stress and the preterm infants risk re-hospitalisation. The French neonatal society's aim was to review the literature on how the transition from hospital to home could limit these risks and to produce a position paper. METHODS: A systematic literature review was performed covering 1 January 2000 to 1 January 2018, and multidisciplinary experts examined the scientific evidence. RESULTS: We identified 939 English and French papers and 169 are quoted in the position paper. Most studies stressed the importance of early, personalised and progressive involvement of the family. Healthcare staff and families should assess discharge preparations jointly. This evaluation should assess the capacities of the newborn infant, with regard to its physiological maturity. It should also assess the family's ability to supply the medical, psychological and social assistance required before and after discharge. There should be a structured follow-up process that includes effective communication, various tools, interventions, networks, health and social professionals. CONCLUSION: Discharge preparations may improve the transition from hospital to home and the outcomes for the parents and newborn preterm infant. This early family-centred approach should be structured, coordinated and based on individual needs and circumstances.

Sequelae of Congenital Cytomegalovirus Following Maternal Primary Infections Are Limited to Those Acquired in the First Trimester of Pregnancy.

BACKGROUND: The known relationship between the gestational age at maternal primary infection an the outcome of congenital CMV is based on small, retrospective studies conducted between 1980 and 2011. They reported that 32% and 15% of cases had sequelae following a maternal primary infection in the first and second or the third trimester, respectively. We aimed to revisit this relationship prospectively between 2011 and 2017, using accurate virological tools. METHODS: We collected data on women with a primary infection and an infected child aged at least 1 year at the time of analysis. An accurate determination of the timing of the primary infection was based upon serial measurements of immunoglobulin (Ig) M and IgG and on IgG avidity in sera collected at each trimester. The case outcome was assessed according to a structured follow-up between birth and 48 months. RESULTS: We included 255 women and their 260 fetuses/neonates. The dating of the maternal infection was prospective in 86% of cases and retrospective in 14%. At a median follow-up of 24 months, the proportion of sensorineural hearing loss and/or neurologic sequelae were 32.4% (95% confidence interval [CI] 23.72-42.09) after a maternal primary infection in the first trimester, 0 (95% CI 0-6.49) after an infection in the second trimester, and 0 (95% CI 0-11.95) after an infection in the third trimester (P < .0001). CONCLUSIONS: These results suggest that a cytomegalovirus infection can be severe only when the virus hits the fetus in the embryonic or early fetal period. Recent guidelines recommend auditory follow-ups for at least 5 years for all infected children. This raises parental anxiety and generates significant costs. We suggest that auditory and specialized neurologic follow-ups may be recommended only in cases of a maternal infection in the first trimester.

Safety of a Triple-chamber Bag Parenteral Nutrition in Children Ages up to 24 Months: An Observational Study.

OBJECTIVES: Hypermagnesemia has been reported in preterm neonates treated with commercial pediatric triple-chamber bag (3CB) parenteral nutrition (PN). This postmarketing study was requested by the European Medicines Agency to assess the safety of a 3CB PN product in full-term neonates and children up to 24 months of age. METHODS: This prospective, multicenter, observational study enrolled hospitalized, full-term, newborn infants and children up to 24 months of age receiving >70% of nutrition as PN and requiring ≥50% of nutrition as PN for ≥5 days. All patients received 3CB PN during the study for ≤15 days. The primary outcome was serum magnesium, summarized by age group (0-1, >1-12, and >12-24 months). Secondary outcomes were nutritional intake and adverse events (AEs), including clinically significant abnormal laboratory results and vital signs. RESULTS: A total of 102 eligible patients were included. Median (interquartile range) parenteral magnesium intake was 0.23 (0.18-0.30) mmol ·â€Škg ·â€Šday. Mean serum magnesium showed no consistent changes during treatment in any age group. One moderate and 3 mild AEs of hypermagnesemia were reported in 4 patients (3.9%), all ages 0 to 1 month. Other AEs in >2 patients were hypertriglyceridemia (6.9%), laryngitis (3.9%), hyperkalemia, hypokalemia, hyponatremia, hypophosphatemia, and neonatal hypotension (each 2.9%). Other serum electrolytes were stable, and revealed no safety concerns. CONCLUSIONS: Mean serum magnesium levels were not affected by 3CB PN in full-term neonates and children up to 24 months of age. The risk of hypermagnesemia AEs was low when providing median parenteral magnesium of 0.2 to 0.3 mmol ·â€Škg ·â€Šday in this population.

Early-onset neonatal sepsis is associated with a high heart rate during automatically selected stationary periods.

AIM: This study examined the heart rate variability characteristics associated with early-onset neonatal sepsis in a prospective, observational controlled study. METHODS: Eligible patients were full-term neonates hospitalised with clinical signs that suggested early-onset sepsis and a C-reactive protein of >10 mg/L. Sepsis was considered proven in cases of symptomatic septicaemia, meningitis, pneumonia or enterocolitis. Heart rate variability parameters (n = 16) were assessed from five-, 15- and 30-minute stationary sequences automatically selected from electrocardiographic recordings performed at admission and compared with a control group using the U-test with post hoc Benjamini-Yekutieli correction. Stationary sequences corresponded to the periods with the lowest changes of heart rate variability over time. RESULTS: A total of 40 full-term infants were enrolled, including 14 with proven sepsis. The mean duration of the cardiac cycle length was lower in the proven sepsis group than in the control group (n = 11), without other significant changes in heart rate variability parameters. These durations, measured in five-minute stationary periods, were 406 (367-433) ms in proven sepsis group versus 507 (463-522) ms in the control group (p < 0.05). CONCLUSION: Early-onset neonatal sepsis was associated with a high mean heart rate measured during automatically selected stationary periods.

Mild head injury and attention deficit hyperactivity disorder in children.

PURPOSE: Post-concussion syndrome is a well-described complication following moderate and severe head trauma but whether it occurs after mild head injury in children remains unclear. The aim of this study was to evaluate whether exposure to mild head injury with potential additional risk factors (non-surgical lesion on computed tomographic, high kinetic trauma, or Glasgow Coma Scale <15) is associated with attention deficit hyperactivity disorder (ADHD) after the head trauma. METHODS: This study was performed in an emergency department on children admitted between 2009 and 2013. It compared victims of mild head injury aged 6-16 years with matched children presenting isolated non-surgical forearm fracture (ratio1/2). ADHD was assessed using Conners' Global Index-Parent short version 3-40 months after the trauma. The patients were compared using chi-square test or Fisher's exact test, t test or u-test as appropriate with a p value set at 0.05. RESULTS: During the study period, 676 patients were admitted for mild head injury. Among them, 34 (5 %) fulfilled the inclusion criteria and were compared with 64 matched patients admitted for a forearm fracture. The groups were comparable. ADHD was observed in both groups (18 % in the mild head injury group, 11 % in the control group) with no significant differences between groups. The prevalence was high when compared to an expected frequency of 3.5-5.6 % in children aged 6-12 years in the general population. CONCLUSIONS: These results suggest that pre-existing ADHD may have contributed to injury proneness in both groups and does not argue for a specific risk of ADHD induced by mild head injury. The diagnosis of ADHD should be evoked at admission of children aged 6-16 years presenting with a trauma.

Recursive Model Identification for the Evaluation of Baroreflex Sensitivity.

A method for the recursive identification of physiological models of the cardiovascular baroreflex is proposed and applied to the time-varying analysis of vagal and sympathetic activities. The proposed method was evaluated with data from five newborn lambs, which were acquired during injection of vasodilator and vasoconstrictors and the results show a close match between experimental and simulated signals. The model-based estimation of vagal and sympathetic contributions were consistent with physiological knowledge and the obtained estimators of vagal and sympathetic activities were compared to traditional markers associated with baroreflex sensitivity. High correlations were observed between traditional markers and model-based indices.

Early detection of late-onset neonatal sepsis from noninvasive biosignals using deep learning: A multicenter prospective development and validation study.

BACKGROUND: Neonatal sepsis is responsible for significant morbidity and mortality worldwide. Its accurate and timely diagnosis is hindered by vague symptoms and the urgent necessity for early antibiotic intervention. The gold standard for diagnosing the condition is the identification of a pathogenic organism from normally sterile sites via laboratory testing. However, this method is resource-intensive and cannot be conducted continuously. OBJECTIVE: This study aimed to predict the onset of late-onset sepsis (LOS) with good diagnostic value as early as possible using non-invasive biosignal measurements from neonatal intensive care unit (NICU) monitors. METHODS: In this prospective multicenter study, we developed a multimodal machine learning algorithm based on a convolutional neural network (CNN) structure that uses the power spectral density (PSD) of recorded biosignals to predict the onset of LOS. This approach aimed to discern LOS-related pathogenic spectral signatures without labor-intensive manual artifact removal. RESULTS: The model achieved an area under the receiver operating characteristic score of 0.810 (95 % CI 0.698-0.922) on the validation dataset. With an optimal operating point, LOS detection had 83 % sensitivity and 73 % specificity. The median early detection was 44 h before clinical suspicion. The results highlighted the additive importance of electrocardiogram and respiratory impedance (RESP) signals in improving predictive accuracy. According to a more detailed analysis, the predictive power arose from the morphology of the electrocardiogram's R-wave and sudden changes in the RESP signal. CONCLUSION: Raw biosignals from NICU monitors, in conjunction with PSD transformation, as input to the CNN, can provide state-of-the-art prediction performance for LOS without the need for artifact removal. To the knowledge of the authors, this is the first study to highlight the independent and additive predictive potential of electrocardiogram R-wave morphology and concurrent, sudden changes in the RESP waveform in predicting the onset of LOS using non-invasive biosignals.

Risk factors for unexpected infant death among very premature infants in France.

BACKGROUND: Prematurity is one of the risk factors for sudden unexpected infant death (SUID), a phenomenon that remains poorly explained. MATERIALS AND METHODS: The analysis of specific factors associated with SUID among very premature infants (VPI) was performed through a retrospective review of data collected in the French SUID registry from May 2015 to December 2018. The factors associated with SUID among VPI were compared with those observed among full-term infants (FTI). Results are expressed as means (standard deviation [SD]) or medians (interquartile range [IQR)]. RESULTS: During the study period, 719 cases of SUID were included in the registry, 36 (incidence: 0.60 ‰) of which involved VPI (gestational age: 29.2 [2] weeks, 1157 [364]) g] and 313 (0.18 ‰) involved FTI (gestational age: 40 [0.8] weeks, 3298 [452] g). The infants' postnatal age at the time of death was similar in the two groups: 15.5 (12.2-21.8) vs. 14.5 (7.1-23.4) weeks. We observed low breastfeeding rates and a high proportion of fathers with no occupation or unemployment status among the VPI compared to the FTI group (31% vs. 55 %, p = 0.01 and 32% vs. 13 %, p = 0.05, respectively). Among the VPI, only 52 % were in supine position, and 29 % were lying prone at the time of the SUID (compared to 63 % and 17 %, respectively, in the FTI group). CONCLUSION: This study confirms prematurity as a risk factor for SUID with no difference in the SUID-specific risk factors studied except for breastfeeding and socioeconomic status of the fathers. VPI and FTI died at similar chronological ages with a high proportion of infants dying in prone position. These results argue for reinforcement of prevention strategies in cases of prematurity.

The development and preliminary evaluation of a clinician e-learning training platform for a neonatal sepsis risk monitor for use in ICU settings.

BACKGROUND: Training clinicians on the use of hospital-based patient monitoring systems (PMS) is vital to mitigate the risk of use errors and of frustration using these devices, especially when used in ICU settings. PMS training is typically delivered through face-to-face training sessions in the hospital. However, it is not always feasible to deliver training in this format to all clinical staff given some constraints (e.g., availability of staff and trainers to attend in-person training sessions and the costs associated with face-to-face training). OBJECTIVE: The literature indicates that E-learning has the potential to mitigate barriers associated with time restrictions for trainers and trainees and evidence shows it to be more flexible, and convenient for learners in healthcare settings. This study aimed to develop and carry out a preliminary evaluation via a case study of an e-learning training platform designed for a novel neonatal sepsis risk monitor system (Digi-NewB). METHODS: A multi-modal qualitative research case study approach was used, including the analysis of three qualitative data sources: (i) audio/video recordings of simulation sessions in which participants were asked to operate the system as intended (e.g., update the clinical observations and monitor the sepsis risk), (ii) interviews with the simulation participants and an attending key opinion leader (KOL), who observed all simulation sessions, and (iii) post-simulation survey. RESULTS: After receiving ethical approval for the study, nine neonatal intensive care unit (NICU) nurses completed the online training and participated in the simulation and follow-up interview sessions. The KOL was also interviewed, and seven out of the nine NICU nurses answered the post-simulation survey. The video/audio analysis of the simulations revealed that participants were able to use and interpret the Digi-NewB interface. Interviews with simulation participants and the KOL, and feedback extracted from the survey, revealed that participants were overall satisfied with the training platform and perceived it as an efficient and effective method to deliver medical device training. CONCLUSIONS: This study developed an online training platform to train clinicians in the use of a critical care medical device and carried out a preliminary evaluation of the platform via a case study. The e-learning platform was designed to supplement and enhance other training approaches. Further research is required to evaluate the effectiveness of this approach.

Educational Concerns About the Safety of Cataract Surgery During Residency: The E3CAPS Pedagogic Study.

INTRODUCTION: Cataract surgery is the most common surgical procedure performed in France. While the incidence of intraoperative complications affecting visual prognosis is extremely low, given the large number of patients operated on, the absolute number of patients affected by complications is quite high. Complication rates are significantly higher when ophthalmology residents (ORs) perform the surgery. Although lack of experience remains the main risk factor, sleep deprivation may adversely affect ORs' successful surgery rate. The value of the EyeSi® surgical simulator in initial training has been demonstrated to increase cataract surgery safety through the transfer of surgical skills from the simulator to the operating room. However, there is no consensus regarding how much training is needed before the first-time ORs are allowed to operate. There is also no scientific evidence that sleep deprivation is associated with a decrease in surgical performance. Establishing a validated protocol for cataract surgery training using the EyeSi surgical simulator (referred to further as the EyeSi) and identifying risk factors for intraoperative complications related to sleep deprivation will improve cataract surgery safety and lead to the reorganization of our healthcare systems. METHODS AND PLANNED OUTCOMES: This multi-centre educational cohort study will include two distinct axes which will both aim to reduce the risks of cataract surgery. Enrollment will include 16 first-year ORs for Axis 1 and 25 experienced residents for Axis 2, all from the University Hospitals of Nantes, Tours, Angers and Rennes. Axis 1 will focus on investigating the learning curve of first-year ORs using the EyeSi, following the training program recommended by the "College des Ophtalmologistes Universitaires de France" in order to set up a future "licence to operate." Axis 2 will evaluate the impact of sleep deprivation on the surgical performance of experienced ORs using the EyeSi. TRIAL REGISTRATION: ClinicalTrial.gov identifier: NCT05722080.

Benefits of a new pediatric triple-chamber bag for parenteral nutrition in preterm infants.

OBJECTIVES: The aim of this study was to evaluate the efficacy, safety, flexibility, and ease of handling and use of the Ped3CB-A 300  mL, the first ready-to-use multichamber parenteral nutrition (PN) system, with optional lipid bag activation, specially designed for administration to preterm infants. MATERIALS AND METHODS: In this prospective, open-label, multicenter, noncomparative, phase III clinical trial, preterm infants were treated with Ped3CB-A for 5 to 10 consecutive days. RESULTS: A total of 113 preterm infants were enrolled in the study and 97 (birth weight 1382 ±â€Š520 g; gestational age 31.2 ±â€Š2.5 weeks; postnatal age administration 5.6 ±â€Š6.1 days) were included in the per protocol analysis accounting for 854 perfusion days. Double-chamber bag activation was used for 32 perfusion days. Macronutrient, electrolyte, and mineral supplements were primarily administered through a Y-line or directly in the activated bag. In all, 199 additions (mainly sodium, 95%) were made to the Ped3CB-A bags on 197 infusion days (23.1%) in 43 infants (44.3%). More than 1 of these nutrients was added to the bag on only 1 perfusion day. Mean and maximum parenteral nutrient intakes were 2.8 ±â€Š0.7 and 3.6 ±â€Š0.8  g amino acids per kilogram per day, and 80 ±â€Š20 and 104 ±â€Š22  kcal · kg(-1) · day(-1). Mean weight gain represented 10.0, 21.5, and 22. 6 g · kg(-1) · day(-1) according to age at inclusion (0-3, 4-7, or >7 days of life). A visual analog scale was completed and produced positive results. No adverse events were attributable to the design of the Ped3CB-A system. CONCLUSIONS: Ped3CB-A provides easy-to-use, well-balanced, and safe nutritional support. Nutritional intakes and weight gain were within the recent PN recommendations in preterm infants.