Research In Practice Blog
In a new Research Letter published by JAMA Network Open, a team of researchers from Clinical Futures at Children’s Hospital of Philadelphia (CHOP) investigated the declining rates of Vitamin K and Hepatitis B Vaccine administration in newborns. The researchers aimed to determine if newborn sex influences parental acceptance of these interventions.
What is known about Vitamin K and Hepatitis B Vaccine Administration:
Newborn intramuscular vitamin K (VK) prophylaxis prevents potentially life-threatening complications associated with vitamin K deficiency bleeding (VKDB), including catastrophic intracranial or gastrointestinal hemorrhage that can result in permanent brain damage or death. Administration of the Hepatitis B vaccine (HBV) within 24 hours of birth is recommended for all newborns weighing more than 2 kg (or about 4 pounds). This practice aims to prevent vertical transmission of hepatitis B from mother to infant, which can result in chronic liver disease or liver cancer.
In the University of Pennsylvania health system, VK is administered to all newborns shortly after birth unless parents decline. HBV is given to medically stable newborns with parental consent. Due to a six-fold increased bleeding risk in the absence of VK prophylaxis, many hospitals have policies requiring that male infants be administered VK prior to receiving a circumcision during the birth hospitalization. Study authors hypothesized that preferences regarding circumcision may influence parental acceptance of VK and other newborn care practices, and that sex-specific differences in VK and HBV administration may occur.
How this study was performed:
The research team, which includes Clinical Futures experts Sarah Coggins, MD, MSCE; Dustin Flannery, DO, MSCE; Sagori Mukhopadhyay, MD, MMSc; and Karen Puopolo, MD, PhD, conducted a retrospective study of all live births occurring between 2018 and 2025 at three centers within the University of Pennsylvania Health System in Philadelphia, PA. This analysis involved approximately 93,000 newborns eligible for well-newborn care, specifically those born at or above 35 weeks of gestation.
The team extracted maternal and newborn characteristics from electronic medical records, along with VK and HBV administration during the birth hospitalization. Researchers estimated the relationship between newborn sex and parental refusal of VK and HBV using multivariable logistic regression, and calculated sex-specific annual rates of VK and HBV administration.
What this research adds:
Female newborns were significantly less likely to receive VK prophylaxis and the hepatitis B vaccine, though the impact of female sex was stronger upon VK nonreceipt compared to HBV nonreceipt. Two-thirds of newborns not administered VK were female. VK and HBV administration decreased significantly among both sexes between 2018 and 2025.
Clinical Implications
Rising misinformation and distrust of the medical system are implicated in VK and HBV refusal, despite the demonstrated safety of both interventions. Sociocultural, religious, and individual factors likely influence parental decisions to decline recommended, evidence-based newborn care. Researchers determined that further studies are necessary to examine sex-specific rates of newborn VK and HBV administration, as well as rates of VKDB and neonatal hepatitis B infection on a national level. Innovative strategies are needed to reduce sex-specific disparities in VK and HBV administration and limit life-threatening morbidity among female newborns.
There are minimal available data describing parental attitudes to newborn care practices through an infant sex-specific perspective. Researchers hypothesize that a desire for circumcision may influence VK acceptance among otherwise-hesitant parents of male newborns. These data reinforce that vitamin K refusal rates are increasing, disproportionately affecting female newborns, and placing more newborn infants at risk for severe bleeding and death.
Clinical Futures authors: Sarah Coggins, MD, MSCE, Dustin Flannery, DO, MSCE, Sagori Mukhopadhyay, MD, MMSc, and Karen Puopolo, MD, PhD
Citation: