Vitamin K refusal among US newborns nearly doubles from 2017 to 2024

Routine intramuscular vitamin K administration at birth has been a standard preventive practice in the United States for more than 60 years and has nearly eliminated vitamin K deficiency bleeding. However, new national data suggest that a growing proportion of newborns are not receiving this intervention, according to a large retrospective cohort study published online in JAMA.^1,2

Using data from Epic Systems’ Cosmos research platform, investigators evaluated trends in intramuscular vitamin K administration among infants born between January 2017 and December 2024. The analysis included more than 5 million newborns from 403 hospitals across all 50 states and the District of Columbia, offering one of the most comprehensive assessments of vitamin K administration practices to date.

Study design and population

The investigators conducted a retrospective cohort study of infants born at 35 to 43 weeks’ gestation whose birth hospitals reported at least 10 deliveries per year during each year of the study period. The Epic Cosmos platform includes deidentified, patient-level electronic health record data from participating health systems nationwide.

The primary outcome was nonreceipt of routine intramuscular vitamin K prophylaxis at birth. Maternal and infant characteristics associated with vitamin K nonreceipt were examined, and trends over time were assessed using both unadjusted analyses and multivariable logistic regression models. Adjusted percentages accounted for covariates associated with vitamin K administration in bivariate analyses.

Increasing rates of vitamin K nonreceipt

Among 5,096,633 newborns included in the analysis, 199,571 infants (3.92%) did not receive intramuscular vitamin K at birth. The proportion of newborns not receiving vitamin K increased steadily over the study period, from 2.92% in 2017 to 5.18% in 2024. This upward trend was statistically significant in unadjusted analyses.

After multivariable adjustment, the estimated percentage of newborns not receiving vitamin K also increased over time, rising from 2.57% (95% CI, 2.52%–2.63%) in 2017 to 4.62% (95% CI, 4.55%–4.70%) in 2024. The authors noted that maternal and infant characteristics remained largely stable across the study period, suggesting that the observed increase was not driven by demographic shifts in the population.

Characteristics associated with vitamin K nonreceipt

Several maternal and infant factors were associated with a higher likelihood of vitamin K nonreceipt. Rates were highest among infants identified as non-Hispanic White or classified as other or unknown race and ethnicity. Vaginal delivery was also associated with a higher rate of nonreceipt compared with cesarean delivery.

Insurance type, residential setting, infant sex, and birth weight showed minimal differences between infants who did and did not receive vitamin K. Social vulnerability, as measured by the Centers for Disease Control and Prevention Social Vulnerability Index, was not strongly associated with nonreceipt.

Context and clinical implications

The authors compared their findings with prior studies and noted that the observed rates were higher than those reported in some earlier multi-state analyses but consistent with data from certain state-level studies conducted before the COVID-19 pandemic. Importantly, the increase in vitamin K nonreceipt appeared to begin before 2020, suggesting that pandemic-related skepticism toward preventive health interventions may not fully explain the trend.

Vitamin K deficiency bleeding is rare but can be severe, including late-onset intracranial hemorrhage. Newborns are particularly vulnerable due to limited placental transfer of vitamin K, low concentrations in breast milk, and immature gastrointestinal absorption. Routine intramuscular prophylaxis at birth remains the most effective preventive strategy.

The study did not capture reasons for vitamin K nonreceipt, as parental refusal data and clinician documentation regarding counseling were not available. Additionally, births occurring outside of hospital settings were not included, which may result in an underestimation of nonreceipt rates, given higher refusal rates reported in planned home births.

Need for further evaluation

The authors emphasized the need for additional research to determine whether rising rates of vitamin K nonreceipt are associated with increased rates of major bleeding events. They also highlighted the importance of standardized clinician communication and public health strategies to support evidence-based newborn care.

Although the findings are limited to infants born at 35 weeks’ gestation or later and to hospitals participating in the Epic Cosmos platform, the large sample size and national scope provide valuable insight into evolving patterns of newborn preventive care in the United States.

References

1. Scott K, Miller E, Culhane JF, et al. Trends in Vitamin K Administration Among Infants. JAMA. Published online December 8, 2025. doi:https://doi.org/10.1001/jama.2025.21460
2. Loyal J, Shapiro ED. Refusal of intramuscular vitamin K by parents of newborns: a review. Hosp Pediatr. 2020;10(3):286-294. doi:10.1542/hpeds.2019-0228