Neonatal Safety Research Articles

Parent Perception of Child Safety following Admission to a Neonatal Unit.

Parent partnership is a key aspect of neonatal hospital care. However, there is a lack of information regarding parents' perception of neonatal safety. This study explores parents' opinions on safety during their child's hospitalization to identify points for improvement. We used a questionnaire, validated by the Spanish National Healthcare Authorities, on perception of safety with respect to hospital health care. Thirty-seven parents of 20 newborns treated in the neonatal intensive care unit (NICU) and 139 parents of newborns in intermediate care (IC) participated in this study. With regard to overall perception of safety, more than 96% of parents felt "very safe" or "fairly safe." In the NICU, an area for improvement detected was to ask parents more often their opinion about the care or treatment provided to their child. In IC, three points for improvement were identified from the group of parents whose child was admitted directly to IC: the consistency of the information received, the request for consent for procedures, and the request for an opinion on their child's care and treatment. Only four parents reported that their child suffered an incident. Regarding incident management, parents were not completely satisfied with the information they received. To the best of our knowledge, this is the first study of parent perception of patient safety in a neonatal unit using a validated questionnaire. Our findings suggest that parents can provide valuable information on neonatal safety, which can then be used to identify areas for improvement. · There is a lack of information regarding parents' perception of neonatal safety.. · This study explores parent's opinion about safety of their child during the hospitalization.. · Our findings suggest that parents can provide valuable information to identify improvement areas..

Efficacy and safety of oral misoprostol vs transvaginal balloon catheter for labor induction: An observational study within the SWEdish Postterm Induction Study (SWEPIS).

Induction of labor is increasing. A common indication for induction of labor is late term and postterm pregnancy at 41 weeks or more. We aimed to evaluate if there are any differences regarding efficacy, safety, and women's childbirth experience between oral misoprostol and transvaginal balloon catheter for cervical ripening in women with a low-risk singleton pregnancy and induction of labor at 41+0 to 42+0 to 1 weeks of gestation. In this observational study, based on data from the Swedish Postterm Induction Study (SWEPIS), a multicenter randomized controlled trial, a total of 1213 women with a low-risk singleton pregnancy at 41 to 42 weeks of gestation were induced with oral misoprostol (n=744) or transvaginal balloon catheter (n=469) at 15 Swedish delivery hospitals. The primary efficacy outcome was vaginal delivery within 24h and primary safety outcomes were neonatal and maternal composite adverse outcomes. Secondary outcomes included time to vaginal delivery and mode of delivery. Women's childbirth experience was assessed with the Childbirth Experience Questionnaire (CEQ 2.0) and visual analog scale. We present crude and adjusted mean differences and relative risks (RR) with 95% CI. Adjustment was performed for a propensity score based on delivery hospital and baseline characteristics including Bishop score. Vaginal delivery within 24h was significantly lower in the misoprostol group compared with the balloon catheter group (46.5% [346/744] vs 62.7% [294/469]; adjusted RR 0.76 95% CI 0.640.89]). Primary neonatal and maternal safety outcomes did not differ between groups (neonatal composite 3.5% [36/744] vs 3.2% [15/469]; adjusted RR 0.77 [95% CI 0.31-1.89]; maternal composite 2.3% [17/744] vs 1.9% [9/469]; adjusted RR 1.70 [95% CI 0.58-4.97]). Adjusted mean time to vaginal delivery was increased by 3.8h (95% CI 1.3-6.2h) in the misoprostol group. Non-operative vaginal delivery and cesarean delivery rates did not differ. Women's childbirth experience was positive overall and similar in both groups. Induction of labor with oral misoprostol compared with a transvaginal balloon catheter was associated with a lower probability of vaginal delivery within 24h and a longer time to vaginal delivery. However, primary safety outcomes, non-operative vaginal delivery, and women's childbirth experience were similar in both groups. Therefore, both methods can be recommended in women with low-risk postdate pregnancies.

The addition of fetal scalp blood lactate measurement as an adjunct to cardiotocography to reduce caesarean sections during labour: The Flamingo randomised controlled trial.

Fetal scalp blood sampling for lactate measurement (FBSLM) is sometimes used to assist in identification of the need for expedited birth in the presence of an abnormal cardiotocograph (CTG). However, there is no randomised controlled trial evidence to support this. To determine whether adding FBSLM reduces the risk of birth by emergency caesarean section in labours complicated by an abnormal CTG, compared with CTG without FBS. Labouring women at a tertiary maternity hospital in Melbourne, Australia with a singleton, cephalic presentation, at ≥37weeks gestation with an abnormal CTG pattern were randomised to the intervention (n=61), with intermittent FBSLM in addition to CTG monitoring, or control (CTG without FBS, n=62). The primary outcome was rate of birth by caesarean section. Secondary outcomes included overall operative birth and fetal and neonatal safety endpoints. ACTRN12611000172909. The smaller than anticipated sample was unable to demonstrate an effect from adding FBSLM to CTG monitoring on birth by caesarean section vs monitoring by CTG without FBS (25/61 and 28/62 respectively, P=0.64, risk ratio 0.91, 95% confidence intervals 0.60-1.36). One newborn infant in the CTG group met the criteria for the composite neonatal outcome of death or serious outcome, neonatal encephalopathy, five-minute Apgar score<4, neonatal resuscitation, admission to neonatal intensive care unit for 96h or more. We were unable to provide robust evidence of the effectiveness of FBSLM to improve the specificity of the CTG in the assessment of fetal wellbeing.

Maternal and neonatal health care worker well-being and patient safety climate amid the COVID-19 pandemic

ObjectiveTo assess maternal and neonatal healthcare workers (HCWs) perspectives on well-being and patient safety amid the COVID-19 pandemic.Study designAnonymous survey of HCW well-being, burnout, and patient safety over the prior conducted in June 2020. Results were analyzed by job position and burnout status.ResultWe analyzed 288 fully completed surveys. In total, 66% of respondents reported symptoms of burnout and 73% felt burnout among their co-workers had significantly increased. Workplace strategies to address HCW well-being were judged by 34% as sufficient. HCWs who were “burned out” reported significantly worse well-being and patient safety attributes. Compared to physicians, nurses reported higher rates of unprofessional behavior (37% vs. 14%, p = 0.027) and difficulty focusing on work (59% vs. 36%, p = 0.013).ConclusionThree months into the COVID-19 pandemic, HCW well-being was substantially compromised, with negative ramifications for patient safety.

COMPARISON OF INTRAPARTUM MANAGEMENT BETWEEN INTERNATIONAL STANDARDS WITH THE MALAYSIAN GUIDELINES

Evidence-based recommendations on intrapartum care are important to ensure the safety of mothers and neonates. The objective of this study was to compare two established guidelines for intrapartum care to provide clinicians with more comprehensive recommendations on intrapartum management. We carried out a descriptive analysis of guidelines from the Integrated Management of Pregnancy and Childbirth (IMPAC) guidelines published by the World Health Organization, and the Perinatal Care Manual published by the Ministry of Health Malaysia, on intrapartum care to determine differences, if any, with regards to management. Latent, active and the second phase of labour are defined differently in both guidelines. Both guidelines showed high similarity in the steps of clinical management for all phases of labour but differed in foetal monitoring methods, indications for episiotomy, mood and behavior assessment, universal precautions, pain management, and placental disposal. Both guidelines had similar managements for most of the problems encountered during the intrapartum period except for preterm labour and multiple births which have substantial differences. Malaysian guidelines highlight additional systems such as the red alert system, and referral and retrieval system, which would enhance the quality of intrapartum management. The IMPAC guidelines emphasize supportive care, birth companionship, maternal care and monitoring up to one hour after placental delivery; and home birth management; these are inadequately explained or lacking in Malaysian guidelines. From the comparison, it was seen that substantial variation exists in intrapartum management between both guidelines that indicates the need for better evidences to synthesize a more comprehensive set of guidelines for the improvement in intrapartum care.

Safety of tocilizumab in COVID-19 pregnant women and their newborn: A retrospective study.

What is known and objectiveTocilizumab is an IL‐6 receptor inhibitor agent which has been proposed as a candidate to stop the inflammatory phase of infection by the severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2). However, safety data of tocilizumab in pregnant women and their newborn are scarce. We aimed to describe maternal and neonatal safety outcomes associated with tocilizumab treatment in pregnant women with severe COVID‐19.MethodsThis is a retrospective study of severe COVID‐19 pregnant women, treated with tocilizumab in two Spanish hospitals between 1 March and 31 April 2020. Demographics, medical history, clinical and radiologic findings, treatment information and laboratory data of mothers and their newborns were collected from electronic medical records.Results and discussionA total of 12 pregnant women were identified to have received tocilizumab during pregnancy in the two hospitals. Median gestational age at admission was 27.7 weeks (interquartile range, 18.0–36.4). Most of them received lopinavir/ritonavir, azithromycin and hydroxychloroquine, two patients received corticosteroids and one received interferon beta 1B. All 12 pregnancies resulted in live births. Somatometric values were normal for all newborns, and evolution at 14 and 28 days was favourable for all of them. Hepatotoxicity was observed in 2 patients, which improved or resolved at discharge. Cytomegalovirus reactivation was detected in another patient who had also received corticosteroids for 15 days, causing a congenital infection in her newborn. Both hepatotoxicity and viral reactivation adverse events were classified as possibly related to tocilizumab administration according to Naranjo's causality algorithm.What is new and conclusionsIt does not appear that tocilizumab has detrimental effects for the mother and newborn. Close monitoring of infections should be considered, especially if other immunosuppressive agents are used.

French Ambulatory Cesarean: Mother and Newborn Safety

(Int J Gynecol Obstet. 2020;148:198–204) Cesarean delivery involves a longer length of hospital stay, higher rates of morbidity, and greater costs and need for care compared with vaginal delivery. Misgav Ladach cesarean (MLC) is a widely used cesarean procedure, though it may impede future fertility. French Ambulatory Cesarean Section (FAUCS) appears to shorten recovery time. This study aimed to assess the results of FAUCS for maternal and neonatal safety in a unit that introduced FAUCS in January 2018.

Peripartum cardiomyopathy.

Peripartum cardiomyopathy is now increasingly recognized as a cause of heart failure in the later months of pregnancy and early postpartum period. Clinical diagnosis may be challenging as it closely resembles several common medical and obstetric complications. Complex pathogenesis, unpredictable onset, staggered recovery, and unanticipated fetomaternal risks pose unique challenge to clinicians. Prevalence seems to vary with race, geographic location, and diagnostic criteria. The presence of multiple risk factors substantially elevates the risk of PPCM. Transthoracic echocardiographic examination can exclude the majority of the mimickers. Symptomatic presentation is initially limited to, varying grades of low cardiac output syndrome. Rarely, PPCM begins with decompensated heart failure and cardiovascular collapse. Guideline-directed medical therapy involves graded initiation and titration of heart failure medications while ensuring the fetal and neonatal safety. Anesthetic and obstetric management should be individualized to improve fetomaternal outcomes. However, emergent cesarean delivery may be required in women with decompensated heart failure and cardiovascular collapse. An early institution of mechanical circulatory support has shown to improve outcome. Bromocriptine and other experimental drugs designed to target pathogenic pathway have yielded mixed results. A further change in approach to management requires a comprehensive understanding of pathophysiology and fetomaternal safety profiles of heart failure medications.

Neonatal Safety and Medical Products to Support Feeding

Neonatal Safety and Medical Products to Support Feeding

Outcomes of the novel Odon Device in indicated operative vaginal birth

BackgroundNo new method of assisting vaginal birth has been introduced into clinical practice since the development of the vacuum extractor in the 1950s. The Odon Device is a new device that employs a circumferential air cuff over the fetal head to assist birth. In this study, the Odon Device has been used to assist vaginal birth for standard clinical indications.ObjectiveThis study aimed to investigate the clinical impact, safety, and acceptability of the Odon Device to women, their babies, and clinicians and to assess the feasibility of recruiting women to an interventional intrapartum research study.Study DesignThis is a nonrandomized, single-arm interventional feasibility study of the Odon Device for operative vaginal birth undertaken in a single maternity unit: Southmead Hospital, Bristol, United Kingdom. The Odon Device was used to assist birth in 40 women who required the birth to be assisted for suspected fetal compromise and/or prolonged second stage of labor. The primary clinical outcome was the proportion of births successfully assisted with the Odon Device, and the primary feasibility outcome was the proportion of eligible women who were approached and who agreed to participate. Neonatal outcome data were reviewed at day 28, and maternal outcomes were investigated up to day 90.ResultsBetween October 2018 and January 2019, 298 of 384 approached, eligible women (77.6%) consented to participate. Of these women, 40 received the intervention—the use of the Odon Device. Birth was assisted in all cephalic (occiput anterior, occiput transverse, and occiput posterior) fetal positions, at all stations at or below the ischial spine and with or without regional analgesia. The Odon Device was effective in 19 of 40 cases (48%). Of the 40 births, 21 (52.5%) required additional assistance: 18 of 40 births (45%) were completed using nonrotational forceps, 1 of 40 births (3%) required rotational forceps, and 2 of 40 births (5%) required an emergency cesarean delivery. There was no serious maternal or neonatal adverse event related to the use of the device, and there was no serious adverse device effect. There were 4 devices (10%) that were ineffective because of a manufacturing fault. Furthermore, 39 of 40 women (98%) reported a high birth perception score. All practitioners were able to use the device as intended, although some steps in using the device were reported to be easier to perform (setup and deflation of air chamber) than others (application of the device and withdrawal of the applicator).ConclusionRecruitment to an interventional study of a new device for operative vaginal birth was feasible; 78% of eligible women were willing to participate, often expressing an aspiration for an alternative to forceps and vacuum. The success rate of the Odon Device was lower than reported success rates of vacuum and forceps; however, in this study, the device had been used to assist birth for standard clinical indications. There was no significant maternal or neonatal safety concern associated with the use of the device, although the number of births studied was small. Further feasibility study to establish iterative changes to the device, technique, and clinical indications is necessary.

Fetal physiology cardiotocography training, a regional evaluation

IntroductionCardiotocography (CTG) has its limits in detecting fetal acidosis and intrapartum asphyxia. Our aim was to evaluate a CTG training programme based on fetal physiology in the Mediterranean perinatal network. MethodsProfessionals from 41 maternity units of the Mediterranean network were invited to participate in a CTG masterclass based on fetal physiology in March 2019 and October 2019. They were asked to react to three practical cases by a physiological approach before the training course (T0), one month after (T1) and six to seven months after (T2). The mean scores were compared by using a mixed model including lapse of time to evaluation, profession of participants and level of the maternity unit as fixed effects. ResultsA total of 248 professionals from 32 maternity units finally participated in the organizational audit. By using a mixed model, we found a significant improvement of the mean score at T1=6.44/10 compared to T0=4.97/10 (p<0.0001), and a significant improvement of the mean score obtained at T2=6.17/10 compared to T0 (p<0.0001). T2 scores were not significantly different from T1 scores (p=0.143). DiscussionA CTG training programme based on fetal physiology showed a significant improvement in the professionals’ interpretation of CTG at short term and stable results at long term. Continuing medical education could help maintain and improve knowledge to ensure neonatal safety.

A Neonatal Intensive Care Unit's Experience with Implementing an In-Situ Simulation and Debriefing Patient Safety Program in the Setting of a Quality Improvement Collaborative.

Extensive neonatal resuscitation is a high acuity, low-frequency event accounting for approximately 1% of births. Neonatal resuscitation requires an interprofessional healthcare team to communicate and carry out tasks efficiently and effectively in a high adrenaline state. Implementing a neonatal patient safety simulation and debriefing program can help teams improve the behavioral, cognitive, and technical skills necessary to reduce morbidity and mortality. In Simulating Success, a 15-month quality improvement (QI) project, the Center for Advanced Pediatric and Perinatal Education (CAPE) and California Perinatal Quality Care Collaborative (CPQCC) provided outreach and training on neonatal simulation and debriefing fundamentals to individual teams, including community hospital settings, and assisted in implementing a sustainable program at each site. The primary Aim was to conduct two simulations a month, with a goal of 80% neonatal intensive care unit (NICU) staff participation in two simulations during the implementation phase. While the primary Aim was not achieved, in-situ simulations led to the identification of latent safety threats and improvement in system processes. This paper describes one unit’s QI collaborative experience implementing an in-situ neonatal simulation and debriefing program.

Operative vaginal delivery and third grade educational outcomes

Operative vaginal delivery rates continue to drop nationally with many citing neonatal safety concerns as a primary driver of this decrease. Previous evidence on short-term neonatal outcomes does not support this concern. This study aimed to better understand the impact of delivery mode on childhood educational outcomes. A statewide retrospective cohort was created in which third grade Rhode Island Department of Education data for 2014 to 2017 were linked to Rhode Island Department of Health birth certificate data. Children's third grade reading and math proficiencies were compared by the mode of delivery listed in their birth certificates. The study population was limited to children who were term, singleton births without congenital anomalies. The mode of delivery was classified as operative vaginal (forceps or vacuum), primary cesarean, or spontaneous vaginal delivery. Children born via repeat cesarean delivery were excluded. Bivariate analyses were conducted to assess differences in demographic variables between mothers and children by mode of delivery and between reading and math proficiencies and mode of delivery. Bivariable and multivariable log-binomial regression was used to examine the association between subject proficiency and predictors including mode of delivery, gestational age, sex, race/ethnicity, and lunch subsidy. Of the 18,247 children who met the inclusion criteria, 6% were delivered by operative vaginal delivery, 19% by primary cesarean delivery, and the remaining 75% by spontaneous vaginal delivery. After adjustment for confounders including gestational age at delivery, child's race/ethnicity, sex, and socioeconomic factors, there was no difference in reading proficiency (adjusted risk ratio, 1.03; 95% confidence interval, 0.96-1.10) or math proficiency (adjusted risk ratio, 1.01; 95% confidence interval, 0.95-1.08) in those born by operative vaginal delivery compared with primary cesarean delivery, and no difference was found in either proficiency when spontaneous vaginal delivery was compared with primary cesarean delivery (reading, adjusted risk ratio, 0.97; 95% confidence interval, 0.93-1.01; math, adjusted risk ratio, 0.98; 95% confidence interval, 0.94-1.01). Operative vaginal delivery was not associated with differences in later childhood educational outcomes after adjusting for baseline differences. This should assuage previous concerns about long-term safety outcomes after operative vaginal delivery and may assist in shared decision making when operative vaginal or primary cesarean delivery is being considered.

Retrospective Analysis of Obstetric Intensive Care Unit Admissions Reveals Differences in Etiology for Admission Based on Mode of Conception

(Anesth Analg. 2020;130:436–444) As births using assisted reproductive technology increase, the maternal and neonatal safety of these pregnancies continues to be of concern. There are established associations between assisted reproductive technology pregnancies and a number of adverse outcomes, including gestational diabetes, hypertensive disorders of pregnancy, obstetric hemorrhage, abnormal placentation, and cesarean delivery. There is a lack of studies examining the risk of intensive care unit (ICU) admission in women using assisted reproductive technology. This study compared parturients who conceived via in vitro fertilization (IVF) and those who did not in terms of etiology and course of ICU admission, particularly focusing on postpartum hemorrhage.

Single Dose Abacavir Pharmacokinetics and Safety in Neonates Exposed to Human Immunodeficiency Virus (HIV).

Abacavir is a potential option for prophylaxis and early treatment of human immunodeficiency virus (HIV), but no data are available in neonates. Ten neonates administered a single abacavir dose of 8 mg/kg before 15 days of life had substantially higher exposures than those reported in infants and children, with no reported adverse events.

Barriers of Medication Administration Error Reporting in Neonatal and Neonatal Intensive Care Units

Introduction: Medication administration error is the most common type of error in the field of medicine which is a risk factor for neonatal safety. These errors should be reported in order to prevent or mitigate their occurrence. In this regard, the present study aimed to determine the barriers of reporting medication administration errors from the point of view of nurses in neonatal and neonatal intensive care units. Materials and Methods: This descriptive cross-sectional study was performed on 157 nurses who were selected using the census sampling method. The participants were nurses of neonatal and neonatal intensive care units in the hospitals affiliated to Shahid Beheshti University of Medical Sciences in Tehran, Iran. Moreover, the required data were collected using the second part of the Medication Administration Error Reporting Survey whose psychometric properties (content validity, face validity, construct validity, and reliability) were determined beforehand. Results: Results of factor analysis indicated the fitness of the data of the Persian version of the scale with 16 items and four factors. Based on the findings, from the point of view of nurses, “fear” and “administrative response” were the most important barriers to reporting errors, in that order. The most and least common fears of nurses were the fear of negative perceptions and complaints of the family of patients (4.95±1.28) and the fear of reprimand by physicians (3.22±1.43), respectively. Moreover, the most important barrier in reporting the errors concerning the administrative response was the lack of positive feedback regarding the correct medication administration (4.22±1.62). Conclusion: According to the results, it can be concluded that from the viewpoint of nurses, fear and administrative response are barriers to reporting medication administration errors.

Neonatal Intubation: Past, Present, and Future.

* Abbreviations: NEAR4NEOS: : National Emergency Airway Registry for Neonates 3D-CT: : 3-dimensional computed tomography Neonatal intubation is a lifesaving skill that has been performed by clinicians for over 200 years. Throughout history, the techniques used for neonatal intubation have improved and will continue to advance in the future. Although the incidence of neonatal intubation has decreased over time, the focus on neonatal intubation safety has increased. Current and future efforts to improve neonatal intubation success and safety are critical to improving neonatal outcomes. After completing this article, readers should be able to: 1. Summarize the history of neonatal intubation. 2. Recognize trends in the incidence of neonatal intubation. 3. Describe current and future efforts to improve neonatal intubation safety. Neonatal intubation is a lifesaving procedure. Neonatal intubation has been an essential skill in the practice of neonatology since the subspecialty was founded in the 1970s; however, the origins of neonatal intubation date back over 200 years. (1)(2)(3) Multiple advances have taken place in the practice of neonatal intubation since it was first described. Continued advances will undoubtedly take place in the future. Although the incidence of neonatal intubation has decreased over time, intubation remains a critical skill for neonatal clinicians. Current and future efforts focused on improving neonatal intubation safety are critical to improving neonatal outcomes. In this review, we examine the past, present, and future of neonatal intubation. ### The First Intubation Techniques The earliest accounts of neonatal resuscitation date back to the mid-1700s when Benjamin Pugh used a small tube made of coiled wire and covered in leather to ventilate the lungs of asphyxiated newborns. (2)(4) The Copenhagen obstetrician Paul Scheel published the first detailed description of neonatal tracheal intubation in 1798:“Having cleaned the throat, we come to the trachea itself. I believe it is best evacuated with a syringe attached to a long flexible tube, the diameter of which fits in the …

Comparison of the effects of epidural and spinal anesthesia on analgesia and blood gases in neonates born by natural vaginal delivery: A clinical trial study

Introduction: One of the concerns of painless deliveries is the safety of neonates. This clinical trial study aimed to compare the effects of epidural and spinal anesthesia on the mortality rate of neonates.&#x0D; Methods: This clinical trial was conducted in Hamadan Hospital in Iran. Ninety women, ages 18 to 45, were randomly assigned to receive epidural or subdural anesthesia. Using a checklist, the following were collected: demographic information, midwifery, hemodynamic status, mothers' pain intensity, and analyses of the baby's umbilical cord blood. The data were analyzed by SPSS version 16 for statistical analysis. Twenty-two of the patients with spinal anesthesia and epidural anesthesia were excluded from the study.&#x0D; Results: There was no significant difference between the two groups in terms of age, gestational age, parity, and severity of pain before or after anesthesia. The hemodynamic status of the mothers before and during the first postoperative period was in the normal range, except that in the spinal group, a decrease in systolic blood pressure was observed in normal range compared with the epidural anesthesia group. In blood gas analysis, the mean pH, partial pressure of carbon dioxide (PCO2), and bicarbonate (HCO3) did not show significant differences between the two groups (p &gt; 0.05). The only complications were acidosis and epidural anesthesia.&#x0D; Conclusion: Based on the findings of the present study, both spinal and epidural opioids have no adverse effects on the health of neonates. However, both spinal and epidural opioid are preferred due to fewer changes in the hemodynamic changes in mothers and in umbilical cord blood gas.

Assessment and Optimization of the Pediatric Parenteral Nutrition Preparation Process in a Hospital Pharmacy.

Parenteral nutrition (PN) is associated with risks that could threaten the clinical condition of premature neonates hospitalized in the neonatal intensive care unit. In this work, risk-analysis methodology was implemented to contain the risks associated with the PN production process and improve PN safety. The Failure Modes, Effects, and Criticality Analysis was performed by a multidisciplinary team. All potential failure modes of the PN preparation process were recorded, and associated risks were scored based on their severity, occurrence, and detectability, with a risk priority number (RPN). All identified failure scenarios and the respective work stages were ranked in descending order of criticality. Corrective actions were proposed to address critical points, and the safety of the process was reassessed by the same method in a prospective manner. The highest RPN scores were obtained with the PN composition calculation performed manually (RPN: 530) or electronically (RPN: 478), completion of the PN medical order form (RPN: 354), manual compounding of PN admixtures (RPN: 258), and the structure/organization/maintenance of the PN preparation unit (RPN: 133). The quality and safety of PN admixtures could be compromised by many critical factors, such as the increased particle-microbial load in the unit and the inadequate training/experience of the involved health professionals and their incompliance with the given instructions. The implementation of the proposed corrective measures is expected to reduce the risks of the overall PN production process by 67.5%. Improvement of the PN production process through risk-analysis methodologies enhances safety for premature neonates.

Conceptual and ethical problems underpinning calls to abandon vaginal breech birth

The view that vaginal breech birth is unjustifiable due to neonatal safety concerns has resulted in continued calls for breech pregnancies to be managed via a policy of planned caesarean birth. Vaginal breech birth has of course always occurred, but women with term breech pregnancies who seek to have a vaginal birth often face coercive pressures to have a caesarean birth instead. In this paper I argue that even if there is population level evidence that vaginal birth is relatively riskier for the breech presenting fetus, implementing a policy of planned caesarean birth would essentially be an unjustified attempt at forced medical intervention upon women. Advocates of a policy of planned caesarean birth often conflate the acceptability of allocating participants to a treatment group (policy) within the context of a randomized controlled trial with the justifiability of doing that as part of individual health care. Calls for obstetricians to “abandon vaginal breech birth” mistakenly position vaginal breech birth itself as a form of medical intervention that can simply be removed as an option for women by obstetricians. In reality, abandoning vaginal breech birth would entail abandoning women by denying them access to healthcare options that are otherwise available to any woman having a vaginal birth.