The proportion of US newborns not receiving prophylactic intramuscular vitamin K at birth increased from 3% to 5% between 2017 and 2024, according to a research letter published in JAMA.
The retrospective cohort study analyzed data from more than 5 million newborns across 403 hospitals in all 50 states and the District of Columbia using the Epic Systems' Cosmos research platform. Overall, 199,571 of 5,096,633 newborns (4%) did not receive intramuscular vitamin K during the study period.
"A multipronged approach composed of interventions including public health regulation at the state level and standardized practice regarding clinician communication with patients regarding vitamin K refusal at the hospital level is urgently needed to improve rates of highly effective prophylactic intramuscular vitamin K administration to prevent bleeding and its associated morbidity and mortality," wrote lead study author Kristan Scott, MD, of the Division of Neonatology at The Children's Hospital of Philadelphia, and colleagues.
The study included newborns of 35 to 43 weeks' gestation born at hospitals with at least 10 births per year throughout the entire study period. Race and ethnicity data, along with maternal and newborn characteristics, were obtained from electronic health records.
Researchers identified several factors associated with not receiving vitamin K. Non-Hispanic White newborns had the highest rate of nonreceipt at 4%, compared with 3% among Hispanic newborns and 3% among non-Hispanic Black newborns among the fewest rates. Newborns delivered vaginally were more likely not to receive vitamin K (4%) compared with those delivered via cesarean (3%). The rate was also higher among newborns in the "other or unknown" race and ethnicity category at 6%.
No maternal or infant characteristics changed significantly over time during the study period.
The researchers noted that while the increase in nonreceipt may be associated with public skepticism regarding pediatric preventive interventions following the COVID-19 pandemic, the upward trend began subtly prior to 2020. Routine newborn intramuscular vitamin K prophylaxis has nearly eliminated vitamin K deficiency bleeding in the US since initiation of universal administration in 1961.
Newborns require prophylaxis at birth because of minimal vitamin K placental transfer, poor gastrointestinal absorption, and low concentrations in breast milk. Some parents refuse vitamin K administration in newborns, citing concerns about necessity, injection pain, and possible adverse effects.
The findings are consistent with a 2016 North Carolina study of more than 18,000 newborns but higher than rates reported in a 2018 study of 102,878 newborns across 34 states (1%).
Study limitations include lack of data from parents or clinicians on reasons for nonreceipt, though refusal is likely the major contributor. The findings are generalizable only to infants of at least 35 weeks' gestation. Vitamin K administration in out-of-hospital births was not captured, so observed rates of nonreceipt may be an underestimate, as vitamin K refusal rates are higher for planned home births.
The researchers called for further study to evaluate whether these trends are associated with increased risk of major bleeding such as intracranial hemorrhage.
The Children's Hospital of Philadelphia Institutional Review Board deemed this study to be non-human subjects research.
Mr Miller reported grants from the Centers for Disease Control and Prevention, and Dr McKenney reported grants from the Office of the Assistant Secretary for Health, Department of Health and Human Services. No other disclosures were reported.
Source: JAMA Network
