The Impact of Maternal Characteristics on the Moderately Premature Infant: An Antenatal Maternal Transport Clinical Prediction Rule

Background: Moderately premature infants, defined here as those born between 30 $\frac{0}{7}$ and 34 $\frac{6}{7}$ weeks gestation, comprise 3.9% of all births in the United States and 32% of all preterm births. While long-term outcomes for these infants are better than for less mature infants, morbidity and mortality are still substantially increased in comparison to infants born at term. There is an added survival benefit resulting from birth at a tertiary neonatal care center, and although many of these infants require tertiary level care, delivery at lower level hospitals and subsequent neonatal transfer are still common. Objective: Our primary aim was to determine the impact of maternal characteristics and antenatal medical management on the early neonatal course of the moderately premature infant. The secondary aim was to create a clinical prediction rule to determine which infants require intubation and mechanical ventilation in the first 24 hours of life. Such a prediction rule could inform the decision to transfer maternal-fetal patients prior to delivery to a facility with a Level III Neonatal Intensive Care Unit (NICU), where optimal care could be provided without the requirement for a neonatal transfer. Methods: Data for this analysis came from the cohort of infants in the Moderately Premature Infant Project (MPIP) database, a multi-center cohort study of 850 infants born at gestational age 30 $\frac{0}{7}$ to 34 $\frac{6}{7}$ weeks, who were discharged home alive. We built a logistic regression model to identify maternal characteristics associated with need for tertiary care, as measured by administration of surfactant. Using statistically significant covariates from this model, we then created a numerical decision rule to predict need for tertiary care. Results: In multivariate modeling, 4 factors were associated with reduction in the need for tertiary care, including, surfactant administration, including non-White race (OR=0.5, [0.3, 0.7], older gestational age, female gender (OR=0.6 [0.4, 0.8]) and use of antenatal corticosteroids (OR=0.5, [0.3, 0.8]). The clinical prediction rule to discriminate between infants who received surfactant, versus those who did not, had an area under the curve of 0.77 [0.73, 0.8]. Conclusions: Four antenatal risk factors are associated with a requirement for Level III NICU care as defined by the need for surfactant administration. Future analyses will examine a broader spectrum of antenatal characteristics and revalidate the prediction rule in an independent cohort

Factors influencing decision making in neonatology: inhaled nitric oxide in preterm infants.

ObjectiveWe studied decision making regarding inhaled nitric oxide (iNO) in preterm infants with Pulmonary Hypertension (PH).Study designWe asked members of the AAP-Society of Neonatal-Perinatal Medicine and Division-Chiefs to select from three management options- initiate iNO, engage parents in shared decision making or not consider iNO in an extremely preterm with PH followed by rating of factors influencing their decision.ResultsThree hundred and four respondents (9%) completed the survey; 36.5% chose to initiate iNO, 42% to engage parents, and 21.5% did not consider iNO. Provider's prior experience, safety, and patient-centered care were rated higher by those who initiated or offered iNO; lack of effectiveness and cost considerations by participants who did not chose iNO.ConclusionsMost neonatologists offer or initiate iNO therapy based on their individual experience. The minority who chose not to consider iNO placed higher value on lack of effectiveness and cost. These results demonstrate a tension between evidence and pathophysiology-based-therapy/personal experience

Newborn Sequencing in Genomic Medicine and Public Health

The rapid development of genomic sequencing technologies has decreased the cost of genetic analysis to the extent that it seems plausible that genome-scale sequencing could have widespread availability in pediatric care. Genomic sequencing provides a powerful diagnostic modality for patients who manifest symptoms of monogenic disease and an opportunity to detect health conditions before their development. However, many technical, clinical, ethical, and societal challenges should be addressed before such technology is widely deployed in pediatric practice. This article provides an overview of the Newborn Sequencing in Genomic Medicine and Public Health Consortium, which is investigating the application of genome-scale sequencing in newborns for both diagnosis and screening

Clinical Sequencing Exploratory Research Consortium: Accelerating Evidence-Based Practice of Genomic Medicine

Despite rapid technical progress and demonstrable effectiveness for some types of diagnosis and therapy, much remains to be learned about clinical genome and exome sequencing (CGES) and its role within the practice of medicine. The Clinical Sequencing Exploratory Research (CSER) consortium includes 18 extramural research projects, one National Human Genome Research Institute (NHGRI) intramural project, and a coordinating center funded by the NHGRI and National Cancer Institute. The consortium is exploring analytic and clinical validity and utility, as well as the ethical, legal, and social implications of sequencing via multidisciplinary approaches; it has thus far recruited 5,577 participants across a spectrum of symptomatic and healthy children and adults by utilizing both germline and cancer sequencing. The CSER consortium is analyzing data and creating publically available procedures and tools related to participant preferences and consent, variant classification, disclosure and management of primary and secondary findings, health outcomes, and integration with electronic health records. Future research directions will refine measures of clinical utility of CGES in both germline and somatic testing, evaluate the use of CGES for screening in healthy individuals, explore the penetrance of pathogenic variants through extensive phenotyping, reduce discordances in public databases of genes and variants, examine social and ethnic disparities in the provision of genomics services, explore regulatory issues, and estimate the value and downstream costs of sequencing. The CSER consortium has established a shared community of research sites by using diverse approaches to pursue the evidence-based development of best practices in genomic medicine

Cost Analyses of Genomic Sequencing: Lessons Learned from the MedSeq Project.

ObjectiveTo summarize lessons learned while analyzing the costs of integrating whole genome sequencing into the care of cardiology and primary care patients in the MedSeq Project by conducting the first randomized controlled trial of whole genome sequencing in general and specialty medicine.MethodsCase study that describes key methodological and data challenges that were encountered or are likely to emerge in future work, describes the pros and cons of approaches considered by the study team, and summarizes the solutions that were implemented.ResultsMajor methodological challenges included defining whole genome sequencing, structuring an appropriate comparator, measuring downstream costs, and examining clinical outcomes. Discussions about solutions addressed conceptual and practical issues that arose because of definitions and analyses around the cost of genomic sequencing in trial-based studies.ConclusionsThe MedSeq Project provides an instructive example of how to conduct a cost analysis of whole genome sequencing that feasibly incorporates best practices while being sensitive to the varied applications and diversity of results it may produce. Findings provide guidance for researchers to consider when conducting or analyzing economic analyses of whole genome sequencing and other next-generation sequencing tests, particularly regarding costs

Cost Analyses of Genomic Sequencing: Lessons Learned from the MedSeq Project.

ObjectiveTo summarize lessons learned while analyzing the costs of integrating whole genome sequencing into the care of cardiology and primary care patients in the MedSeq Project by conducting the first randomized controlled trial of whole genome sequencing in general and specialty medicine.MethodsCase study that describes key methodological and data challenges that were encountered or are likely to emerge in future work, describes the pros and cons of approaches considered by the study team, and summarizes the solutions that were implemented.ResultsMajor methodological challenges included defining whole genome sequencing, structuring an appropriate comparator, measuring downstream costs, and examining clinical outcomes. Discussions about solutions addressed conceptual and practical issues that arose because of definitions and analyses around the cost of genomic sequencing in trial-based studies.ConclusionsThe MedSeq Project provides an instructive example of how to conduct a cost analysis of whole genome sequencing that feasibly incorporates best practices while being sensitive to the varied applications and diversity of results it may produce. Findings provide guidance for researchers to consider when conducting or analyzing economic analyses of whole genome sequencing and other next-generation sequencing tests, particularly regarding costs

California and Oregon NICU Wildfire Disaster Preparedness Tools

The 2020 wildfire season was devastating to the Western United States and affected the region’s NICUs. In this study, we ask the question, “what tools/strategies do medical professionals deem as important and most helpful as they are preparing for wildfire disaster response?” It is a follow up to our previous study: Learning from Wildfire Disaster Experience in California NICUs. We reevaluated how California NICUs dealt with the 2020 wildfires and expanded to Oregon and Southwest (SW) Washington NICUs. We conducted a survey with eleven Oregon and SW Washington NICUs about their wildfire evacuation preparedness. We also interviewed two neonatologists about their wildfire disaster experience evacuating their NICU or preparing to evacuate. Our findings suggest there is more work needed to fully prepare NICUs for wildfire disasters. We hope that by bringing light to the strategies used by affected clinicians, we can educate and support future NICU disaster preparedness responses

Economics of Home Monitoring for Apnea in Late Preterm Infants

BACKGROUND: Apnea of prematurity affects a small proportion but large absolute number of late preterm infants, with out-patient management variably utilized despite relative clinical equipoise and potential for improved cost-effectiveness. METHODS: Over a 5-y period, from 2009 to 2013, infants born at \u3e /=34 weeks gestational age at a level IIIB academic center in Boston, Massachusetts, with discharge-delaying apnea, bradycardia, and desaturation (ABD) events were identified. In-patient costs for discharge-delaying ABD events were compared with hypothetical out-patient management. Out-patient costs took into account 4-10 d of in-patient observation for ABD events before caffeine initiation, 3-5 d of additional in-patient observation before discharge, daily caffeine until 43 weeks corrected gestational age, home pulse oximetry monitoring until 44 weeks corrected gestational age, and consideration of variable readmission rates ranging from 0 to 10%. RESULTS: A total of 425 late preterm and term infants were included in our analysis. Utilization of hypothetical out-patient management resulted in cost savings per eligible patient ranging from $2,422 to$62, dependent upon variable periods of in-patient observation. Sensitivity analysis demonstrated few instances of decreased relative cost-effectiveness. CONCLUSIONS: Out-patient management of discharge-delaying ABD events in a late preterm and term population was a cost-effective alternative to prolonged in-patient observation

Factors influencing decision making in neonatology: inhaled nitric oxide in preterm infants.

ObjectiveWe studied decision making regarding inhaled nitric oxide (iNO) in preterm infants with Pulmonary Hypertension (PH).Study designWe asked members of the AAP-Society of Neonatal-Perinatal Medicine and Division-Chiefs to select from three management options- initiate iNO, engage parents in shared decision making or not consider iNO in an extremely preterm with PH followed by rating of factors influencing their decision.ResultsThree hundred and four respondents (9%) completed the survey; 36.5% chose to initiate iNO, 42% to engage parents, and 21.5% did not consider iNO. Provider's prior experience, safety, and patient-centered care were rated higher by those who initiated or offered iNO; lack of effectiveness and cost considerations by participants who did not chose iNO.ConclusionsMost neonatologists offer or initiate iNO therapy based on their individual experience. The minority who chose not to consider iNO placed higher value on lack of effectiveness and cost. These results demonstrate a tension between evidence and pathophysiology-based-therapy/personal experience

all These People Saved Her Life, but She Needs Me Too : Understanding and Responding to Parental Mental Health in the NICU

To explore the mental health needs of parents of infants in a neonatal intensive care unit (NICU), as well as barriers and solutions to meeting these needs