Anatomical and developmental differences of the parental-offspring interface among experimental animals and humans throughout gestation are reviewed focusing on biodistribution of immunoglobulins (IgG). The formation of the extraembryonic membranes, uteroplacental circulation, and characteristics of the placenta (gross shape, modes of implantation, surface modifications that increase surface area, and extent of embryonic invasion into maternal tissue) are reviewed. Placental physiology and function are covered with attention to transfer of xenobiotics. Placental transfer of immunoglobulins in the human, non-human primate (NHP), rodent, and rabbit is discussed and the transfer of human fragment crystallizable (Fc)-containing biopharmaceuticals and potential impact on developmental toxicity risk assessment are specifically addressed. Safety assessment is often limited to the NHP as the only pharmacologically relevant model, despite poor statistical power as employed in current experimental designs. Although data are limited, the gestational timing of placental IgG transfer in rabbits appears to be more consistent with that of humans (i.e. occurring at the very end and after completion of organogenesis) than that of rodents, making the rabbit a reasonable choice assuming it is pharmacologically relevant. The rodent is not considered the most appropriate model for human placental transfer of Fc-containing biopharmaceuticals because it is currently believed to overestimate exposure during organogenesis. Nevertheless, the rodent may provide a conservative approach for hazard identification. It is clear that additional experimentation is needed to further clarify the timing of prenatal transfer of Fc-containing biopharmaceuticals in various species.
OBJECTIVES: To describe the characteristics and outcomes of children discharged from the hospital with new nasoenteral tube (NET) use after acute hospitalization. METHODS: Retrospective cohort study using multistate Medicaid data of children <18 years old with a claim for tube feeding supplies within 30 days after discharge from a nonbirth hospitalization between 2016 and 2019. Children with a gastrostomy tube (GT) or requiring home NET use in the 90 days before admission were excluded. Outcomes included patient characteristics and associated diagnoses, 30-day emergency department (ED-only) return visits and readmissions, and subsequent GT placement. RESULTS: We identified 1815 index hospitalizations; 77.8% were patients ≤5 years of age and 81.7% had a complex chronic condition. The most common primary diagnoses associated with index hospitalization were failure to thrive (11%), malnutrition (6.8%), and acute bronchiolitis (5.9%). Thirty-day revisits were common (49%), with 26.4% experiencing an ED-only return and 30.9% hospital readmission. Revisits with a primary diagnosis code for tube displacement/dysfunction (10.7%) or pneumonia/pneumonitis (0.3%) occurred less frequently. A minority (16.9%) of patients progressed to GT placement within 6 months, 22.3% by 1 year. CONCLUSIONS: Children with a variety of acute and chronic conditions are discharged from the hospital with NET feeding. All-cause 30-day revisits are common, though revisits coded for specific tube-related complications occurred less frequently. A majority of patients do not progress to GT within a year. Home NET feeding may be useful for facilitating discharge among patients unable to meet their oral nutrition goals but should be weighed against the high revisit rate.
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