Alcohol exposure during pregnancy results in impaired growth, stillbirth, and fetal alcohol spectrum disorder. Fetal alcohol deficits are lifelong issues with no current treatment or established diagnostic or therapeutic tools to prevent and/or ameliorate some of these adverse outcomes. Despite the recommendation to abstain, almost half of the women consume alcohol in pregnancy in the United States. This review focuses on the trends in prenatal alcohol exposure, implications for maternal and fetal health, and evidence suggesting that preconception and the prenatal period provide a window of opportunity to intervene, mitigate, and ideally curtail the lifetime effects of fetal alcohol spectrum disorder.

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Oral administration of engineered immunoglobulins has the potential to prevent enteric pathogen-induced diarrhea in infants. To prevent infection, these antibodies need to survive functionally intact in the proteolytic environment of the gastrointestinal tract. This research examined both ex vivo and in vivo the functional survival across infant digestion of palivizumab, a model FDA-approved recombinant antibody against respiratory syncytial virus (RSV) F protein. Palivizumab-fortified feed (formula or human milk), infant gastric, and intestinal samples were incubated to simulate in vivo digestion (ex vivo digestion). Palivizumab-fortified human milk was also fed to infants, followed by collection of gastric and intestinal samples (in vivo digestion). Palivizumab was purified from the samples of digestate using protein G spin columns followed by filtration through molecular weight cutoff membranes (30 kDa). Palivizumab functional survival across ex vivo and in vivo digestion was determined via an anti-idiotype ELISA and an RSV plaque reduction neutralization test. Palivizumab concentration and RSV neutralization capacity both decreased when incubated in intestinal samples (ex vivo study). The concentration and neutralization activity of orally-supplemented palivizumab also decreased across infant digestion (in vivo study). These results indicate that if recombinant IgGs were selected for oral supplementation to prevent enteric infections, appropriate dosing would need to account for degradation occurring in the digestive system. Other antibody formats, structural changes, or encapsulation could enhance survival in the infant gastrointestinal tract.

Objectives: To assess the effects of Bifidobacterium infantis EVC001 administration on the rate of necrotizing enterocolitis (NEC) in preterm infants in a single Level IV NICU. Study Design: This was a retrospective observational analysis of 2 cohorts of VLBW infants (+/- B. infantis EVC001 probiotic) at OHSU from 2014 to 2020. Outcomes included NEC rates and NEC-associated mortality, including subgroup analysis of ELBW infants. Fishers exact test and log binomial models were used to determine differences between cohorts and risk reduction of NEC. Adjusted number needed to treat was calculated from the cohort coefficient of the model. Results: In this analysis of 483 infants, the difference in rates of NEC between cohorts was statistically significant (11.0% vs. 2.7%, P = 0.0008). The EVC001-fed cohort had a 73% risk reduction of NEC compared to the No EVC001 cohort (adjusted risk ratio 0.270, 95% CI 0.094, 0.614, P = 0.0054) resulting in an adjusted number needed to treat of 12.4 (95% CI 10.0, 23.5) for B. infantis EVC001. There was no NEC-related mortality in the EVC001-fed cohort, yielding statistically significant differences from the No EVC001 cohort overall (0% vs. 2.7%, P = 0.0274) and the ELBW subgroup (0% vs. 5.6%, P = 0.0468). Conclusion(s): B. infantis EVC001 feeding was associated with a significant reduction in the rate of NEC and NEC-related mortality in an observational study of 483 VLBW infants. B. infantis EVC001 supplementation may be considered safe and effective for reducing morbidity and mortality in the NICU.