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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 and 34 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 to 34 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
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