Building a NICU quality & safety infrastructure.

The American Academy of Pediatrics (AAP) Standards for Levels of Neonatal Care, published in 2023, highlights key components of a Neonatal Patient Safety and Quality Improvement Program (NPSQIP). A comprehensive Neonatal Intensive Care Unit (NICU) quality and safety infrastructure (QSI) is based on four foundational domains: quality improvement, quality assurance, safety culture, and clinical guidelines. This paper serves as an operational guide for NICU clinical leaders and quality champions to navigate these domains and develop their local QSI to include the AAP NPSQIP standards.

The entwined circles of quality improvement & advocacy.

Health policy and quality improvement initiatives exist symbiotically. Quality projects can be spurred by policy decisions, such as the creation of financial incentives for high-value care. Then, advocacy can streamline high-value care, offering opportunities for quality improvement scholars to create projects consistent with evidenced-based care. Thirdly, as pediatrics and neonatology reconcile with value-based payment structures, successful quality initiatives may serve as demonstration projects, illustrating to policy-makers how best to allocate and incentivize resources that optimize newborn health. And finally, quality improvement (QI) can provide an essential link between broad reaching advocacy principles and boots-on-the-ground local or regional efforts to implement good ideas in ways that work practically in particular environments. In this paper, we provide examples of how national legislation elevated the importance of QI, by penalizing hospitals for low quality care. Using Medicaid coverage of pasteurized human donor milk as an example, we discuss how advocacy improved cost-effectiveness of treatments used as tools for quality projects related to reduction of necrotizing enterocolitis and improved growth. We discuss how the future of QI work will assist in informing the agenda as neonatology transitions to value-based care. Finally, we consider how important local and regional QI work is in bringing good ideas to the bedside and the community.

Use of a SimBox, a Video-Augmented, Newborn Resuscitation Simulation for Prehospital Providers to Measure Clinical Performance and Educational Experience.

OBJECTIVES: Few studies have described the current clinical practices, adherence to guidelines, and outcomes of newborn resuscitations attended by emergency medical services (EMS). SimBox, a novel, video-augmented simulation, was used to describe the adherence of prehospital providers to Neonatal Resuscitation Program guidelines, to measure satisfaction with the simulation intervention, and to describe the self-reported improvement in knowledge, skills, and attitudes after the simulation. METHODS: A prospective observational cohort study of EMS providers was designed and conducted using SimBox, an open-access simulation platform, and facilitated by EMS educators. Clinical performance measures were collected using a five-item checklist. Simulation satisfaction measures were collected through net promoter scores. Learners' demographics, and self-reported knowledge, skills, and attitudes were measured using a retrospective survey of 25 questions. RESULTS: In total, 33 facilitator and 55 learner surveys were collected across Connecticut, Colorado, and Alaska between July 2021 and September 2022. At least one deviation from clinical guidelines occurred in 22/30 (73.3%) of the sessions, with 10/30 (33.3%) teams inappropriately performing chest compressions, 5/31 (16.1%) teams not warming, drying, stimulating, and suctioning the newborn, and 7/31 (22.6%) teams not performing positive pressure ventilation correctly. Lastly, 10/30 (33.3%) teams administered an incorrect dose of dextrose-containing fluids. Very high levels of satisfaction were reported with net promoter scores of 97 and 82 out of 100 for the facilitator and learner surveys, respectively. Finally, all 55/55 (100%) of the learners strongly or somewhat agreed that the simulation improved their knowledge, teamwork, communication, and psychomotor skills. CONCLUSIONS: In this cohort of prehospital providers, clinical management decisions during a newborn resuscitation simulation often deviated from the gold-standard, newborn resuscitation guidelines. Free, online, open-access simulation resources like SimBox can be used to identify and measure practice deviations from standardized resuscitation protocols in the prehospital setting.

Nurses' knowledge and practice about neonatal pain management in public hospitals in West Oromia, Ethiopia, 2022: multi-centered cross-sectional study.

BACKGROUND: In low-and middle-income countries inadequate neonatal pain management persists as a significant public health issue despite the availability of guidelines. Newborns often experience pain from routine medical and surgical procedures, with limited nurses' knowledge and suboptimal practices posing common obstacles to effective neonatal pain management in hospital settings. Hence, this study aimed to evaluate nurses' knowledge and practices related to neonatal pain management and the factors influencing them in public hospitals in West Oromia, Ethiopia, in 2022. METHODS: A multicenter cross-sectional study was conducted among 203 nurses working in public hospitals in West Oromia from 8th May-6th June 2022. Data was gathered using structured, self-administered questionnaire and sampled through simple random sampling. The collected data were coded and entered into a computer using Epi-Data version 4.6 Statistical Software. They were analyzed using the Statistical Package for Social Science (SPSS; IBM Corporation) version 26. Binary logistic regression was used to identify significant independent variables at p < 0.05. FINDINGS: In this study, 127 (62.6%) exhibited adequate knowledge, while 33 (16.3%) nurses demonstrated good practice in neonatal pain management. Attending lectures or receiving training about neonatal pain management was found to be significantly associated with nurses' knowledge of neonatal pain management [AOR, 2.31, 95%CI; 1.29-4.27]. On the other, having adequate knowledge of neonatal pain management [AOR, 3.3, 95%CI; 1.14-9.32]; the presence of a pain management policy in place [AOR, 5.44, 95% CI; 1.92-15.37] and attending lectures on neonatal pain management [AOR, 2.55, 95% CI; 1.09-5.97] were found to be significantly associated to nurses' practices. CONCLUSION: Given the substandard level of nurses' practice in neonatal pain management. It is suggested to enhance the nurses' knowledge and practice about neonatal pain management by providing refreshment courses, training sessions, or facilitating nurses' opportunity access to reading resources about neonatal pain management.

Prioritizing Disease Diagnosis in Neonatal Cohorts through Multivariate Survival Analysis: A Nonparametric Bayesian Approach.

Understanding the intricate relationships between diseases is critical for both prevention and recovery. However, there is a lack of suitable methodologies for exploring the precedence relationships within multiple censored time-to-event data, resulting in decreased analytical accuracy. This study introduces the Censored Event Precedence Analysis (CEPA), which is a nonparametric Bayesian approach suitable for understanding the precedence relationships in censored multivariate events. CEPA aims to analyze the precedence relationships between events to predict subsequent occurrences effectively. We applied CEPA to neonatal data from the National Health Insurance Service, identifying the precedence relationships among the seven most commonly diagnosed diseases categorized by the International Classification of Diseases. This analysis revealed a typical diagnostic sequence, starting with respiratory diseases, followed by skin, infectious, digestive, ear, eye, and injury-related diseases. Furthermore, simulation studies were conducted to demonstrate CEPA suitability for censored multivariate datasets compared to traditional models. The performance accuracy reached 76% for uniform distribution and 65% for exponential distribution, showing superior performance in all four tested environments. Therefore, the statistical approach based on CEPA enhances our understanding of disease interrelationships beyond competitive methodologies. By identifying disease precedence with CEPA, we can preempt subsequent disease occurrences and propose a healthcare system based on these relationships.

Early and extended erythropoietin monotherapy after hypoxic ischaemic encephalopathy: a multicentre double-blind pilot randomised controlled trial.

OBJECTIVE: To examine the feasibility of early and extended erythropoietin monotherapy after hypoxic ischaemic encephalopathy (HIE). DESIGN: Double-blind pilot randomised controlled trial. SETTING: Eight neonatal units in South Asia. PATIENTS: Neonates (≥36 weeks) with moderate or severe HIE admitted between 31 December 2022 and 3 May 2023. INTERVENTIONS: Erythropoietin (500 U/kg daily) or to the placebo (sham injections using a screen) within 6 hours of birth and continued for 9 days. MRI at 2 weeks of age. MAIN OUTCOMES AND MEASURES: Feasibility of randomisation, drug administration and assessment of brain injury using MRI. RESULTS: Of the 154 neonates screened, 56 were eligible; 6 declined consent and 50 were recruited; 43 (86%) were inborn. Mean (SD) age at first dose was 4.4 (1.2) hours in erythropoietin and 4.1 (1.0) hours in placebo. Overall mortality at hospital discharge occurred in 5 (19%) vs 11 (46%) (p=0.06), and 3 (13%) vs 9 (40.9%) (p=0.04) among those with moderate encephalopathy in the erythropoietin and placebo groups. Moderate or severe injury to basal ganglia, white matter and cortex occurred in 5 (25%) vs 5 (38.5%); 14 (70%) vs 11 (85%); and 6 (30%) vs 2 (15.4%) in the erythropoietin and placebo group, respectively. Sinus venous thrombosis was seen in two (10%) neonates in the erythropoietin group and none in the control group. CONCLUSIONS: Brain injury and mortality after moderate or severe HIE are high in South Asia. Evaluation of erythropoietin monotherapy using MRI to examine treatment effects is feasible in these settings. TRIAL REGISTRATION NUMBER: NCT05395195.

Performance and incidence of diarrhea in suckling Jersey calves supplemented with mineral-vitamin complex and Virginiamycin.

The rearing of calves is an essential activity of a dairy system, as it impacts the future production of these animals. This study aims to evaluate the incidence of diarrhea, performance, and blood parameters of suckling calves that received mineral-vitamin supplementation in milk plus virginiamycin that was offered in milk (via the abomasum) or by esophageal tube (via the rumen). Twenty-seven calves were used, from the first week to 60 days of age, submitted to the following treatments: CONTROL, without supplementation; MILK, supplementation of 20 g of a mineral-vitamin complex with 100 mg of virginiamycin, diluted in milk; RUMEN, supplementation of 20 g of a mineral-vitamin complex diluted in milk and 100 mg of virginiamycin in gelatin capsules via an esophageal applicator. MILK and RUMEN calves had lower fecal consistency scoring, fewer days with scores 2 and 3 throughout the experimental period, and lower spending on medication compared to the CONTROL animals. Supplemented calves had higher fat and protein intake and reached feed intake of 600 g earlier than CONTROL animals, but did not differ in performance and hematological parameters. Supplementation with virginiamycin and vitamin-mineral complex for suckling calves reduced the incidence and days of diarrhea, and reduced medication costs, with no difference in performance, but the supplemented animals had higher initial protein and fat intake and reached targeted feed intake earlier to begin the weaning process.

Neonatal sepsis with meningitis, ventriculitis and brain abscess caused by Edwardsiella tarda.

A case of neonatal sepsis caused by Edwardsiella tarda, an uncommon pathogen typically associated with aquatic lifeforms, is described. The infant presented in septic shock with seizures and respiratory failure and was found to have meningitis, ventriculitis and a brain abscess requiring drainage. Only a small number of case reports of neonatal E. tarda infection, several with sepsis with poor auditory or neurodevelopmental outcomes or meningitis, have been described in the literature. This case report suggests that E. tarda, while uncommon, can be a cause of serious central nervous system disease in the neonatal population and that an aggressive approach to pursuing and treating complications may lead to improved neurodevelopmental outcomes.

Postexchange transfusion-related acute lung injury in a term neonate.

We report a successful case where a newborn with transfusion-related acute lung injury following an exchange transfusion was effectively treated using conservative methods, eliminating the need for surfactant therapy. Very few instances of this complication have been documented globally. A low birth weight, small for gestational age, term neonate, diagnosed with hyperbilirubinaemia due to Rh incompatibility, experienced sudden respiratory distress in the form of severe retractions, tachypnoea and cyanosis 3 hours after the procedure. Neonate required mechanical ventilation on the grounds of mixed acidosis and diffuse alveolar infiltrates on the chest radiograph. The medical team suspected and treated the baby for transfusion-related acute lung injury through conservative measures. Transfusion-related acute lung injury, an acute life-threatening complication of blood component transfusion, can exhibit symptoms in neonates that are frequently misinterpreted as sepsis. The baby was discharged in good health after successful management after 19 days.

Retinal abnormalities in a patient with cutis marmorata telangiectatica congenita.

Cutis marmorata telangiectatica congenita is a rare congenital vascular malformation characterised by cutaneous vascular abnormalities, typically diagnosed at birth or in the early postnatal period. Although typically benign, this disease is associated with other systemic abnormalities, including rare ocular alterations, such as congenital glaucoma, cataracts and retinopathy.This manuscript describes a female infant, who presented with generalised livedo reticularis, a band of alopecia and cutaneous atrophy in the temporal region above the coronal suture. The patient was diagnosed with cutis marmorata telangiectatica congenita by a paediatrician, and an ophthalmological evaluation was requested. A funduscopy examination in both eyes showed temporal and superior retina with avascular areas with new vessels, venous dilations and shunts, and no retinal detachments. Given these findings, we performed retinal photocoagulation laser treatment with excellent results.This case report highlights the importance of early ophthalmological evaluation of children with this disease to prevent secondary complications, such as vitreous haemorrhage and tractional retinal detachment.

Persistent omphalomesenteric duct in an infant with trisomy 21.

We present the case of a term newborn with trisomy 21 who presented to the paediatric emergency department with periumbilical flare and green-brown discharge from a clamped umbilical cord, initially suspected to be omphalitis. However, it was noticed later, that when the infant strained or cried, a thick, bubbling and offensive green-brown discharge came out of the clamped umbilical cord with umbilical flatus. An ultrasound abdomen and umbilical cord confirmed the presence of a persistent omphalomesenteric duct (POMD). He was then transferred to the paediatric surgical unit. There, he underwent a laparotomy and surgical resection of the POMD and was discharged home 2 days later.

Congenital glottic stenosis as a clinical manifestation of FREM1-associated disorders in a neonate with respiratory distress and aphonia.

A female infant born at 38 weeks and 2 days via induced vaginal delivery was admitted to the neonatal intensive care unit for respiratory distress soon after birth. Noted to have aphonia on examination, the patient underwent direct laryngoscopy and was diagnosed with an anterior glottic web and subglottic stenosis. The patient underwent a genetic workup including whole exome sequencing which resulted in a diagnosis of a FREM1-associated disorder. Congenital glottic webs and subglottic stenoses have not been previously described as clinical manifestations of FREM1-associated disorders.

The effects of anaesthesia on cell death in a porcine model of neonatal hypoxic-ischaemic brain injury.

Background: Hypothermia is neuroprotective after neonatal hypoxic-ischaemic brain injury. However, systemic cooling to hypothermic temperatures is a stressor and may reduce neuroprotection in awake pigs. We compared two experiments of global hypoxic-ischaemic injury in newborn pigs, in which one group received propofol-remifentanil and the other remained awake during post-insult hypothermia treatment. Methods: In both studies, newborn pigs were anaesthetised using halothane during a 45-min global hypoxic-ischaemic insult induced by reducing Fio2 and graded hypotension until a low-voltage <7 µV electroencephalogram was achieved. On reoxygenation, the pigs were randomly allocated to receive 24 h of normothermia or hypothermia. In the first study (n=18) anaesthesia was discontinued and the pigs' tracheas were extubated. In the second study (n=14) anaesthesia was continued using propofol and remifentanil. Brain injury was assessed after 72 h by classical global histopathology, Purkinje cell count, and apoptotic cell counts in the hippocampus and cerebellum. Results: Global injury was nearly 10-fold greater in the awake group compared with the anaesthetised group (P=0.021). Hypothermia was neuroprotective in the anaesthetised pigs but not the awake pigs. In the hippocampus, the density of cleaved caspase-3-positive cells was increased in awake compared with anaesthetised pigs in normothermia. In the cerebellum, Purkinje cell density was reduced in the awake pigs irrespective of treatment, and the number of cleaved caspase-3-positive Purkinje cells was greatly increased in hypothermic awake pigs. We detected no difference in cleaved caspase-3 in the granular cell layer or microglial reactivity across the groups. Conclusions: Our study provides novel insights into the significance of anaesthesia/sedation during hypothermia for achieving optimal neuroprotection.

Tiny Tummies, Big Challenges: A Case Series of Neonatal Gastric Perforations.

The main aim of this article is to highlight the clinical features indicating gastric perforation in neonates so that prompt surgery can provide a good outcome for an otherwise fatal condition. Data was collected retrospectively from all neonates who presented to our tertiary care institute with subsequent diagnosis of gastric perforation from January 2020 to December 2023 (three years). Simple statistical analysis involving sums, means, averages, and percentages was used. Five neonates were operated over a period of three years with a diagnosis of gastric perforation. Two of them were spontaneous. Of the remaining three, each one was associated with malrotation, prematurity, and COVID-19. All five cases could be diagnosed with the finding of free gas in the peritoneum on the abdominal radiograph. Overall mortality was 60% (three of five neonates). Neonatal gastric perforation typically occurs in the first week of life, specifically within the second to seventh day. Symptom onset is usually sudden, with abdominal distension as the first sign, with acidic contents causing severe peritonitis and rapid progression to sepsis and shock. Early diagnosis with subsequent timely resuscitation and surgical repair is crucial to good outcomes. Massive pneumoperitoneum on abdominal radiographs with typical signs in a neonate should raise suspicion of gastric perforation, especially in the first week of life.

Vayu bubble continuous positive airway pressure is a promising solution with favorable treatment outcomes for respiratory distress syndrome in newborns: a qualitative study in Bangladesh.

Background: According to Bangladesh Demographic and Health Survey (2022), neonatal mortality, comprising 67% of under-5 deaths in Bangladesh, is significantly attributed to prematurity and low birth weight (LBW), accounting for 32% of neonatal deaths. Respiratory distress syndrome (RDS) is a prevalent concern among preterm and LBW infants, leading to substantial mortality. The World Health Organization (WHO) recommends bubble continuous positive airway pressure (bCPAP) therapy, but the affordability and accessibility of conventional bCPAP devices for a large number of patients become major hurdles in Bangladesh due to high costs and resource intensiveness. The Vayu bCPAP, a simple and portable alternative, offers a constant flow of oxygen-enriched, filtered, humidified, and pressurized air. Our study, conducted in five health facilities, explores the useability, acceptability, and perceived treatment outcome of Vayu bCPAP in the local context of Bangladesh. Methods: A qualitative approach was employed in special care newborn units (SCANUs) of selected facilities from January to March 2023. Purposive sampling identified nine key informants, 40 in-depth interviews with service providers, and 10 focus group discussions. Data collection and analysis utilized a thematic framework approach led by trained anthropologists and medical officers. Results: Service providers acknowledged Vayu bCPAP as a lightweight, easily movable, and cost-effective device requiring minimal training. Despite challenges such as consumable shortages and maintenance issues, providers perceived the device as user-friendly, operable with oxygen cylinders, and beneficial during referral transportation. Treatment outcomes indicated effective RDS management, reduced hospital stays, and decreased referrals. Though challenges existed, healthcare providers and facility managers expressed enthusiasm for Vayu bCPAP due to its potential to simplify advanced neonatal care delivery. Conclusions: The Vayu bCPAP device demonstrated useability, acceptability, and favorable treatment outcomes in the care of neonates with RDS. However, sustained quality service necessitates continuous monitoring, mentoring and retention of knowledge and skills. Despite challenges, the enthusiasm among healthcare providers underscores the potential of Vayu bCPAP to save lives and simplify neonatal care delivery. Development of Standard Operating procedure on Vayu bCPAP is required for systematic implementation. Further research is needed to determine how the utilization of Vayu bCPAP devices enhances accessibility to efficient bCPAP therapy for neonates experiencing RDS.

The impact of antenatal telehealth services on maternal and neonatal outcomes, a comparison of results before and during the COVID-19 pandemic: A systematic review and meta-analysis (The impact of telehealth services on maternal and neonatal outcomes).

OBJECTIVE: This review was conducted to examine the effectiveness of antenatal follow-up using telehealth in the pre-COVID-19 and active pandemic periods. DESIGN: A systematic review and meta-analysis of randomized controlled trials. METHODS: Searches were conducted from inception to September 2023 through PubMed, the Cochrane Library, EBSCO, Embase, Web of Science, all via Ovid SP, the National Thesis Center, TR Index, Turkiye Clinics, and DergiPark Academic. Data were combined in the meta-analysis. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool and quality of evidence according to the Grading of Recommendations Assessment, Development and Evaluation guidelines. RESULTS: The meta-analysis examining the effectiveness of antenatal telehealth services included 35 studies with a total sample size of 16 033. The combined results of the studies revealed that antenatal telehealth services were similar to face-to-face follow-ups for many maternal and newborn health outcomes. Maternal outcomes included abortion, preterm delivery, gestational diabetes, weight gain, hypertensive disorders, maternal hospitalization, number of antenatal follow-ups, use of induction, vaginal and instrumental delivery, planned and emergency cesarean section, shoulder dystocia, episiotomy, perineal laceration, childbirth under the supervision of qualified personnel, breastfeeding problems and postpartum depression. Neonatal outcomes included an APGAR score of <7, neonatal hypoglycemia, hyperbilirubinemia, admission into the neonatal intensive care unit, respiratory distress syndrome, neonatal death, birth weight, low birth weight and macrosomia. However, statistically significant reductions in excessive weight gain (p<0.001) and a 1.23-fold increase in vaccination administration (p=0.001) were observed with telehealth services. Additionally, the effects of telehealth services on preterm and cesarean delivery rates were similar in the pre-pandemic and pandemic periods. CONCLUSION AND IMPLICATIONS FOR PRACTICE AND RESEARCH: This review reveals that while antenatal telehealth services are comparable to face-to-face care in terms of multiple pregnancy, delivery, and neonatal outcomes, they contribute to improvements in preventing extreme weight gain and vaccination hesitancy. These findings suggest that the telehealth method can be used as an alternative to face-to-face monitoring in antenatal follow-ups.

Increased incidence and mortality from Listeria monocytogenes infection in Spain.

BACKGROUND: Listeria monocytogenes (LM) is a health treat worldwide given its high mortality and the growing of high-risk susceptible populations. METHODS: All hospitalizations with a diagnosis of LM in the National Registry of Hospital Discharges were examined in Spain from 2000 to 2021. RESULTS: A total of 8,152 hospital admissions with LM were identified. The mean age was 59.5 years and 48% were immunosuppressed (IS). The rate of LM hospitalizations increased from 5 per 1 million population in 2000 to 8.9 in 2021 (p<0.001). A foodborne outbreak in Andalusia determined a sharp increase of admissions with LM during 2019. The COVID-19 pandemic and lockdowns were associated with a fall in LM admissions. The overall in-hospital mortality was 16.7%. The number of deaths in patients hospitalized with LM rose from 7.8 per 100,000 deceased in 2000 to 18 in 2021 (p<0.001). After adjustment, age >65 years-old (Odds ratio [OR]=2.16), sepsis (OR=2.60), meningoencephalitis (OR=1.72), endocarditis (OR=2.0), neonatal listeriosis (OR=2.10) and IS (OR=2.09) were associated with mortality. CONCLUSIONS: The number of patients hospitalized with LM in Spain has risen significantly from 2000 to 2021. The increase in the rate of admissions and deaths was largely driven by the growing proportion of elderly and of immunosuppressed patients.

Diet Management in Congenital Diarrheas and Enteropathies - General Concepts and Disease-Specific Approach, a Narrative Review.

Congenital diarrheas and enteropathies (CODE) are a group of rare, heterogenous, monogenic disorders that lead to chronic diarrhea in infancy. Definitive treatment is rarely available, and supportive treatment is the mainstay. Nutritional management in the form of either specialized formulas, restrictive diet, or parenteral nutrition support in CODE with poor enteral tolerance, is the cornerstone of CODE treatment and long-term growth. The evidence to support the use of specific diet regimens and nutritional approaches in most CODE disorders is limited due to the rarity of those diseases and the scant published clinical experience. The goal of this review is to create a comprehensive guide for nutritional management in CODE, based on the currently available literature, disease mechanism and the PediCODE group experience. Enteral diet management in CODE can be divided into 3 distinct conceptual frameworks - nutrient elimination, nutrient supplementation, and generalized nutrient restriction. Response to nutrient elimination or supplementation can lead to resolution or significant improvement in the chronic diarrhea of CODE and resumption of normal growth. This pattern can be seen in CODE due to carbohydrate malabsorption, defects in fat absorption and occasionally in electrolyte transport defects. In contrast, general diet restriction is mainly supportive. However, occasionally it allows parenteral nutrition weaning or reduction overtime mainly in enteroendocrine defects and rarely in epithelial trafficking and polarity defects. Further research is required to better elucidate the role of diet in the treatment of CODE and the appropriate diet management for each disease.

Maternal COVID-19 vaccination status and association with neonatal congenital anomalies.

Introduction: Despite recommendations for COVID-19 vaccination in pregnant people, the effect of vaccination on neonatal outcomes remains unknown. We sought to determine the association between COVID-19 vaccination status in pregnancy and presence of neonatally diagnosed congenital anomalies. Methods: A comprehensive vaccine registry was combined with a delivery database to create a cohort including all patients aged 16-55 years with a delivery event between December 10, 2020 and December 31, 2021 at a hospital within the Mayo Clinic Health System. Pregnancy and neonatal outcomes were analyzed in relation to vaccination status and timing, including a composite measure of congenital anomalies diagnosed in neonatal life. Comparisons between cohorts were conducted using chi-square test for categorical and Kruskal-Wallis test for continuous variables. A multivariable logistic regression was modeled to assess the association with congenital anomalies. Results: 5,096 mother-infant pairs were analyzed. A total of 1,158 were vaccinated, with 314 vaccinated in the first trimester. COVID-19 vaccination status, including vaccination during the first trimester of pregnancy, was not associated with an increased risk of composite congenital anomalies. When further examining congenital anomalies by organ system, we did demonstrate a significant difference in eye, ear, face, neck anomalies between vaccinated and not vaccinated groups (Table 3, Not vaccinated = 2.3%, Vaccinated = 3.3%, p-value 0.04) however we did not demonstrate this difference between the 1st trimester and not vaccinated groups (Not vaccinated = 2.3%, 1st Trimester = 2.5%, p-value 0.77). No differences were found between not vaccinated, vaccinated, or 1st trimester vaccinated groups for any other organ systems. There were no differences in birthweight by gestational age, APGAR scores, incidence of NICU admission, or living status of the neonate by vaccination status. Conclusion: We add additional information regarding the safety of COVID-19 vaccination status and timing as it pertains to neonatal composite congenital anomalies, with no association demonstrated. Our findings agree with prior literature that COVID-19 vaccination is not associated with adverse pregnancy outcomes or small for gestational age neonates. Further research is needed to elucidate the association between COVID-19 vaccination and eye, ear, face, neck, anomalies.