Late-onset vitamin K deficiency bleeding in an extremely preterm infant fed an exclusively human milk-based diet.

All newborns need extra phylloquinone (vitamin K1; K1) to prevent vitamin K deficiency bleeding (VKDB). In preterm babies, the main sources are prophylactic K1 given at birth and parenteral and/or enteral feeding thereafter. Preterm babies are at risk of late-onset VKDB if ongoing K1 supplementation is inadequate. For extremely preterm infants fed an exclusive human milk diet, the low K1 content of human milk may predispose them to vitamin K deficiency. Human milk fortification with either bovine milk-derived fortifier or human milk-based fortifier (HMF) made from pooled donor milk is a widely used strategy to improve the micronutrient and growth status of preterm infants. However, the K1 content of HMF is markedly lower than that of bovine-based preparations. We present an unusual case of late-onset VKDB in an extremely preterm infant who received an exclusive human milk diet and HMF and quantify total K1 intake prior to the bleeding.

Take the Shot: A Review of Vitamin K Deficiency.

Vitamin K is essential for the process of coagulation. In its absence, severe and sometimes fatal bleeding events can occur, especially in newborns. Vitamin K prophylaxis at birth has been shown to prevent morbidity and mortality associated with vitamin K deficiency bleeding (VKDB) and is recommended by multiple organizations including the American Academy of Pediatrics and the World Health Organization. Pediatricians should feel comfortable explaining the risks and benefits of vitamin K prophylaxis to families and should be equipped to recognize signs of VKDB, especially given increasing rates of parental refusal. This article aims to improve understanding of VKDB, including prevention, early recognition, and treatment. [Pediatr Ann. 2023;52(2):e42-e45.].

Attention to diseases that re-emerge due to refusal of vitamin K: an infant case.

Intramuscular vitamin K injection is recommended for all newborns to prevent bleeding. However, the number of parents who reject vitamin K is at an increase. We present a 1-month girl who presented with haemorrhagic shock due to extraordinary intra-thoracic bleeding. The patient was treated with thoracentesis and blood transfusion. Parents were informed the about the benefits of Vitamin K and they were convinced to continue a routine immunization programme.

Neonatologists and vitamin K hesitancy.

Hemorrhagic disease of the newborn, more aptly termed "Vitamin K Deficiency Bleeding (VKDB)," has long been recognized as a cause of significant morbidity and mortality in early infancy. A single intramuscular dose of vitamin K administered at birth has virtually eliminated VKDB, and this prophylactic regimen has been recommended by the American Academy of Pediatrics since 1961. Although most newborns in the United States receive vitamin K at birth, a growing number of parents are hesitant about this intervention, citing concerns about harm from the injection, preservatives contained in the medication, and clashes with personal belief systems. Ultimately, there is distrust in the medical establishment as many of these parents also opt out of newborn ophthalmic prophylaxis and importantly, childhood vaccinations, establishing a dangerous public health precedent that will lead to resurgence of vaccine-preventable diseases. Various shared decision making models and educational efforts can assist newborn health care professionals in addressing these parental concerns so that VKDB can be effectively prevented in all newborns.

Hemorrhagic Disease of the Newborn: A Case Series Illustrating Preventable Harm.

Newborns are susceptible to postnatal Vitamin K deficiencies from limited placental transfer, gastrointestinal absorption, and bioavailability in breast milk and formula preparations. For over 50 years, the American Academy of Pediatrics has recommended prophylactic vitamin K to prevent hemorrhagic disease in newborns. Yet, public skepticism contributes to increasing refusal rates. We present three cases of vitamin K-dependent bleeding following parental refusal of postnatal prophylaxis. Two patients experienced intracranial hemorrhage with resultant neurological devastation and mortality, respectively. The third child presented with symptomatic hematuria. Perinatal providers must partner with families and advocate vitamin K prophylaxis to limit unnecessary morbidity and mortality.

Midwives' Perspectives about Vitamin K Prophylaxis Against Vitamin K Deficiency Bleeding of the Newborn.

BACKGROUND: The American Academy of Pediatrics recommends one intramuscular (IM) vitamin K injection at birth to prevent Vitamin K Deficiency Bleeding of the Newborn (VKDB). Among factors associated with IM vitamin K refusal, investigators have reported an increased frequency of IM vitamin K refusal among parents who select midwife-assisted deliveries. Reasons behind this association are unclear. METHODS: To understand the perspectives of midwives on IM vitamin K prophylaxis and approach to counseling parents using qualitative methodology, we conducted in-depth semi-structured interviews of midwives associated with 3 tertiary academic medical centers and surrounding communities in Connecticut, Iowa and Michigan. We used the grounded theory approach and the constant comparative method until saturation was reached. RESULTS: We interviewed 19 white female midwives from different training pathways. Participants who were Certified Nurse Midwives (CNMs) routinely recommended IM vitamin K prophylaxis and Certified Professional Midwives (CPMs) took a more neutral approach. The following 4 themes emerged: (1) Emphasis on an educational approach to counseling that supports parents' decision-making authority; (2) Low-intervention philosophy in the midwifery model of care attracts certain parents; (3) Need for relationship building between midwives and pediatricians and (4) Opportunities for the future. CONCLUSIONS: Midwives in our study perceived that the midwifery model of care, the focus on physiologic birth and prioritizing parents' decision-making autonomy appears to attract a sub-set of expectant parents with certain belief systems who question interventions such as IM vitamin K prophylaxis. There are opportunities for better collaboration between midwives and pediatricians.

Vitamin K and the Newborn Infant.

Intramuscular administration of vitamin K for prevention of vitamin K deficiency bleeding (VKDB) has been a standard of care since the American Academy of Pediatrics recommended it in 1961. Despite the success of prevention of VKDB with vitamin K administration, the incidence of VKDB appears to be on the rise. This increase in incidence of VKDB is attributable to parental refusal as well as lowered efficacy of alternate methods of administration. The aim of this statement is to discuss the current knowledge of prevention of VKDB with respect to the term and preterm infant and address parental concerns regarding vitamin K administration.

Belgian Consensus Recommendations to Prevent Vitamin K Deficiency Bleeding in the Term and Preterm Infant.

Neonatal vitamin K prophylaxis is essential to prevent vitamin K deficiency bleeding (VKDB) with a clear benefit compared to placebo. Various routes (intramuscular (IM), oral, intravenous (IV)) and dosing regimens were explored. A literature review was conducted to compare vitamin K regimens on VKDB incidence. Simultaneously, information on practices was collected from Belgian pediatric and neonatal departments. Based on the review and these practices, a consensus was developed and voted on by all co-authors and heads of pediatric departments. Today, practices vary. In line with literature, the advised prophylactic regimen is 1 or 2 mg IM vitamin K once at birth. In the case of parental refusal, healthcare providers should inform parents of the slightly inferior alternative (2 mg oral vitamin K at birth, followed by 1 or 2 mg oral weekly for 3 months when breastfed). We recommend 1 mg IM in preterm <32 weeks, and the same alternative in the case of parental refusal. When IM is perceived impossible in preterm <32 weeks, 0.5 mg IV once is recommended, with a single additional IM 1 mg dose when IV lipids are discontinued. This recommendation is a step towards harmonizing vitamin K prophylaxis in all newborns.

Vitamin K prophylaxis in newborns.

We looked at existing recommendations and supporting evidence on the effectiveness of vitamin K given after birth in preventing the haemorrhagic disease of the newborn (HDN).We conducted a literature search up to the 10th of December 2019 by using key terms and manual search in selected sources. We summarized the recommendations and the strength of the recommendation when and as reported by the authors. We summarized the main findings of systematic reviews with the certainty of the evidence as reported.All newborns should receive vitamin K prophylaxis, as it has been proven that oral and intramuscular prophylactic vitamin K given after birth are effective for preventing classical HDN. There are no randomized trials looking at the efficacy of vitamin K supplement on late HDN. There are no randomized trials comparing the oral and intramuscular route of administration of prophylactic vitamin K in newborns. From older trials and surveillance data, it seems that there is no significant difference between the intramuscular and the oral regimens for preventing classical and late HDN, provided that the oral regimen is duly completed. Evidence assessing vitamin K prophylaxis in preterm infants is scarce.

[The importance of administering vitamin K intramuscularly in neonates]. / Het belang van intramusculaire vitamine K-toediening bij pasgeborenen.

BACKGROUND: Infants who are born in The Netherlands receive oral vitamin K to prevent bleeding due to a vitamin K deficiency. However the incidence of such bleedings are higher compared to other European countries. Therefore, the Dutch Health Council advised in 2017 to change this guideline from oral to intramuscular administration. CASE DESCRIPTION: A 2 months old girl presented with a fatal intracranial hemorrhage. A day before she developed a hematoma on her foot and orbit. Despite daily oral vitamin K, blood results revealed a severe vitamin K deficiency-related bleeding. Postmortem liver biopsy and genetic studies showed cholestasis as the most likely cause of malabsorption of fat soluble vitamins due to a heterozygous pathogenic variant in the ABCB11 gene, which could possibly be transient. CONCLUSION: Our case illustrates the importance of revising the national guideline for vitamin K prophylaxis to intramuscular administration, according to the recommendation of the Dutch Health Council.

Trends in and Documentation of Refusal of Common Routine Newborn Interventions: 2013-2019.

BACKGROUND: Refusals of intramuscular (IM) vitamin K, ocular prophylaxis, and hepatitis B vaccine (HBV) during the birth hospitalization continue to occur. Refusal of IM vitamin K increases the risk of life-threatening vitamin K deficiency bleeding. Trends in refusal rates and how well clinicians document IM vitamin K refusal is unknown. METHODS: We reviewed charts of livebirths admitted to 5 well newborn units from 2013 to 2019. We report trends in rates of refusal and documentation of no IM vitamin K by clinicians during the birth hospitalization and within the first 6 months of life at emergency department (ED) visits. RESULTS: Of 67 750 live births, 283 (0.4%) did not receive IM vitamin K, and 1645 (2.4%) did not receive ocular prophylaxis. Rates of IM vitamin K refusal increased slightly over time (P < .05). For HBV, 7551 (11.1%) did not receive the birth dose, but refusal rates decreased from 16.1% to 8.7% (P < .0001). Of 283 newborns who did not receive IM vitamin K, refusal was documented in 49.8% of discharge summaries, 17 (6%) had an invasive procedure without documentation of IM vitamin K administration, and 30 (10.6%) infants <6 months old had ED visits. A total of 4 infants were evaluated for potential bleeding, and there was no documentation about IM vitamin K prophylaxis. CONCLUSION: Refusal rates of IM vitamin K and ocular prophylaxis remained low, and uptake of HBV increased over time. Documentation of IM vitamin K refusal by clinicians during the birth hospitalization, before invasive procedures, and in ED visits can be improved.

Uso profiláctico de la vitamina K para prevenir la enfermedad hemorrágica del recién nacido / Prophylactic use of vitamin K to prevent hemorrhagic disease of the newborn

El déficit de vitamina K al nacimiento supone un factor de riesgo para desarrollar la enfermedad hemorrágica del recién nacido (EHRN). Este estado pro hemorrágico puede producir sangrados graves principalmente a nivel cutáneo, gastrointestinal y cerebral. Hay buena evidencia de que la administración de vitamina K en el recién nacido (RN) es segura y eficaz, los daños potenciales son leves, por lo que está claro el beneficio neto a favor de la administración. El grupo PrevInfad recomienda administrar a todos los recién nacidos 1 mg de vitamina K de forma profiláctica por vía intramuscular para prevenir la EHRN. En el documento, se hacen consideraciones especiales para prematuros y para niños cuyos padres rechazan la profilaxis intramuscular. Asimismo, se presenta una propuesta operativa e información para padres (AU)

Vitamin K deficiency at birth is a risk factor for Haemorrhagic disease of the newborn. This bleeding prone situation can produce severe hemorrhages mainly in the skin, gastrointestinal tract and brain.There is strong evidence that the administration of vitamin K to the newborn is safe and effective, potential side effects are mild, so there is a clear benefit of its administration.PrevInfad workgroup recommends the prophylactic administration of 1 mg intramuscular Vitamin K to prevent the Haemorrhagic disease of the newborn.Some special considerations for preterm newborns and for children whose parents reject intramuscular prophylaxis are explained in the document. Moreover, an operative proposal and information for parents are presented. (AU)

Pediatric Emergency Medicine Simulation Curriculum: Vitamin K Deficiency in the Newborn.

Introduction: The American Academy of Pediatrics recommends vitamin K prophylaxis at birth for all newborns to prevent vitamin K deficiency bleeding (VKDB). Despite a lack of evidence for serious harms, barriers to prophylaxis, including parental refusal, are rising, as are cases of VKDB. Methods: This simulation involved an infant presenting to the emergency department who decompensated due to a cerebral hemorrhage caused by VKDB and was treated by pediatric and emergency providers. The case was incorporated into the fellow and division monthly curricula, and participants completed postsimulation surveys. The patient required a secure airway, seizure management, vitamin K, and a fresh frozen plasma infusion upon suspicion of the diagnosis, plus a coordinated transfer to definitive care. The case included a description of the simulated case, learning objectives, instructor notes, an example of the ideal flow of the scenario, anticipated management mistakes, and educational materials. Results: The simulations were carried out with 48 total participants, including 40 fellows and eight attendings, from five different training institutions over 1 year. In surveys, respondents gave overall positive feedback. Ninety-four percent of participants gave the highest score on a Likert scale indicating that the simulation was relevant, and over 80% gave the highest score indicating that the experience helped them with medical management. Discussion: This simulation trained physicians how to recognize and treat a distressed infant with VKDB. The case was perceived to be an effective learning tool for both fellow and attending physicians.

The challenge to define the optimal prophylactic regimen for vitamin K deficiency bleeding in infants.

Infants are at risk of vitamin K deficiency that may lead to vitamin K deficiency bleeding (VKDB). Although many vitamin K prophylactic regimens have been developed throughout the years, still cases of late form VKBD may occur. The introduction of combined prophylactic strategy with prolonged oral prophylaxes after the intramuscular dose at birth has showed a decrease of the late severe VKDB incidence. Nevertheless, there is still lack of consensus about the administration scheme after the first dose at birth. CONCLUSION: Late form VKBD is not eradicated, and the best prophylactic regimen in term and preterm infants is still an open debate.

Vitamin K Deficiency Bleeding: An Ounce of Prevention.

Vitamin K is a fat-soluble vitamin essential for the formation of factors in the clotting cascade. Newborns are born with insufficient levels of vitamin K, resulting in high risk for vitamin K deficiency bleeding (VKDB). Vitamin K deficiency bleeding can occur in the first week of life ("classic" VKDB) and also between 2 weeks and 3 months of age ("late" VKDB). Vitamin K deficiency bleeding can present as bleeding in the skin or gastrointestinal tract, with as many as half of affected neonates experiencing intracranial bleeding. A single intramuscular injection of vitamin K effectively prevents both classic and late VKDB. Although intramuscular vitamin K is safe and effective, VKDB has reemerged because of decreased utilization. Parents refuse intramuscular vitamin K for a variety of reasons, including a disproven association with childhood cancer, the desire to avoid exposure to additives, and valid concerns about early neonatal pain. Many parents request oral vitamin K, an inferior alternative strategy that requires multiple doses utilizing products not designed for neonatal oral administration. In this setting, health care professionals must understand the epidemiology of VKDB and compassionately counsel parents to assuage concerns. Delivery of intramuscular vitamin K to all newborns remains a public health imperative, benefitting thousands of infants annually.

Educating Parents on Vitamin K Prophylaxis for Newborns.

Vitamin K is important in the clotting cascade, and vitamin K prophylaxis is important in preventing vitamin K deficiency bleeding (VKDB) in newborns. Breastfed newborns have been found to be particularly vulnerable to VKDB. Although oral vitamin K is available, there is no version for newborns approved by the U.S. Food and Drug Administration (FDA), and if a dose is missed, the risk of VKDB may more than double. Therefore, an injection is recommended by the American Academy of Pediatrics to prevent VKDB in newborns. Nurses often administer the newborn vitamin K injection, and they play a key role in educating parents and helping them make informed decisions about vitamin K prophylaxis for their newborns.

Applying lessons from vaccination hesitancy to address birth dose Vitamin K refusal: Where has the trust gone?

Refusal of intramuscular Vitamin K at birth is an emerging public health issue resulting in increased rates of intracranial bleeding. Parents who refuse this intervention bear epidemiologic resemblance to vaccine-refusing parents, are geographically clustered and share a mistrust of public health interventions. We review the prevalence of Vitamin K refusal and discuss individual and societal recommendations that may reduce Vitamin K refusal, adapted from vaccine hesitancy literature. We note the prevalence of misinformation on social media as a contributor to refusal and explore how changes in healthcare practices may influence growing physician mistrust. We propose solutions to the issue including state-based mandates and a pervasive social media strategy to combat misinformation as a contributor to Vitamin K refusal.

Vitamin K Deficiency Bleeding in Infancy.

Vitamin K is essential for the synthesis of few coagulation factors. Infants can easily develop vitamin K deficiency owing to poor placental transfer, low vitamin K content in breast milk, and poor intestinal absorption due to immature gut flora and malabsorption. Vitamin K deficiency bleeding (VKDB) in infancy is classified according to the time of presentation: early (within 24 h), classic (within 1 week after birth), and late (between 2 week and 6 months of age). VKDB in infancy, particularly late-onset VKDB, can be life-threatening. Therefore, all infants, including newborn infants, should receive vitamin K prophylaxis. Exclusive breastfeeding and cholestasis are closely associated with this deficiency and result in late-onset VKDB. Intramuscular prophylactic injections reduce the incidence of early-onset, classic, and late-onset VKDB. However, the prophylaxis strategy has recently been inclined toward oral administration because it is easier, safer, and cheaper to administer than intramuscular injection. Several epidemiological studies have shown that vitamin K oral administration is effective in the prevention of VKDB in infancy; however, the success of oral prophylaxis depends on the protocol regimen and parent compliance. Further national surveillance and studies are warranted to reveal the optimal prophylaxis regimen in term and preterm infants.