Healthcare professionals, neonatal units, hospitals, and health services
Statement of standard
Prophylactic supplementation with vitamin K for all infants is given to prevent vitamin K deficiency bleeding (VKDB).
Rationale
Vitamin K deficiency bleeding (VKDB) in infants is prevented by vitamin K supplementation. Healthy newborn infants have low hepatic stores of vitamin K (1) and are at risk of developing serious bleeding, including intracranial hemorrhage, due to low hepatic synthesis of vitamin K–dependent clotting factors. (2,3) Preterm infants appear to be at even higher risk. (4) Vitamin K deficiency bleeding (VKDB) in infants is prevented by vitamin K supplementation. Postnatal supplementation of vitamin K can markedly reduce the incidence of VKDB, associated morbidity, including devastating brain injury, neurodevelopmental impairment and mortality. (5–7)
Healthy infants should either receive 1 mg of vitamin K intramuscular at birth, or three doses of 2 mg vitamin K orally at birth, at four to six days and at four to six weeks, respectively; or 2 mg vitamin K orally at birth followed by weekly doses of 1 mg orally for three months for breastfed infants. (3) Intramuscular application has the best preventive efficiency. (3) A prophylactic regimen for breastfed infants consisting of 1 mg vitamin K orally at birth, followed by low doses of either 25 or 150 μg daily during weeks 2 to 13, is less effective and does not adequately prevent VKDB in breastfed infants with (still undiagnosed) cholestasis. (8,9)
Intramuscular administration of 1 mg of vitamin K at birth efficiently prevents classical VKDB, but does not fully protect against late forms of VKDB. (10–14) VKDB, late form, should be considered when evaluating bleeding during the first months of life, even in infants who received vit. K prophylaxis at birth, especially in exclusively breastfed infants. (15)
The best protection is to administer newborns 1 mg of vitamin K intramuscular at birth. Vitamin K should be administered parenterally to newborn infants who are unwell, those with indications of cholestasis or impaired intestinal absorption, those who are unable to take oral vitamin K, those whose mothers have taken medications that interfere with vitamin K metabolism, and to preterm infants. (16) In preterm infants reduced doses of vitamin K prophylaxis of about 0.5 mg intramuscular for infants >1000 g or 0.2 mg intramuscular/intravenous for infants <1000 g appear to be adequate. (17) Vitamin K supplementation protocols should be developed and implemented in all obstetric and neonatal units. (3,18)
Benefits
Short-term benefits
Reduced risk of Vitamin K deficiency bleeding and related infant mortality and morbidity (11–13)
Long-term benefits
Reduced risk of long-term damage and neurodevelopmental handicap (12)
Reduced risk of healthcare costs arising from chronic morbidity (consensus)
Components of the standard
Component
Grading of evidence
Indicator of meeting the standard
For parents and family
Parents are informed before and after birth by healthcare professionals about the importance of vitamin K supplementation and its benefits. (10)
A (High quality) B (High quality)
Patient information sheet1
For healthcare professionals
A unit guideline on Vitamin K supplementation in all infants is adhered to by all healthcare professionals. (3)
A (High quality) B (High quality)
Guideline
Training on prevention of vitamin K deficiency bleeding (VKDB) is attended by all healthcare professionals.
A (Low quality) B (High quality)
Training documentation
Parental refusal of vitamin K prophylaxis is clearly documented.
B (High quality)
Clinical records
For neonatal unit
A unit guideline on vitamin K supplementation in all infants is available and regularly updated. (3)
A (High quality) B (High quality)
Guideline
Administration of vitamin K supplementation is monitored.
A (Low quality) B (High quality)
Audit report2
For hospital
Training on prevention of VKDB is ensured.
A (Low quality) B (High quality)
Training documentation
For health service
A national guideline on vitamin K supplementation in all infants is available and regularly updated. (3)
A (High quality) B (High quality)
Guideline
Rate of vitamin K deficiency related haemorrhage in infants is monitored.
A (Low quality)
Audit report2
1The indicator “patient information sheet” is an example for written, detailed information, in which digital solutions are included, such as web-based systems, apps, brochures, information leaflets, and booklets.
2The indicator “audit report” can also be defined as a benchmarking report.
Where to go
Further development
Grading of evidence
For parents and family
N/A
For healthcare professionals
N/A
For neonatal unit
N/A
For hospital
Participate in and implement communication strategies to promote acceptance of universal vitamin K supplementation.
A (Low quality)
For health service
Develop and implement communication strategies to promote acceptance of universal vitamin K supplementation.
A (Low quality)
Monitor the proportion of infants who receive vitamin K supplementation according to established standards across the population.
B (High quality)
Getting started
Initial steps
For parents and family
Parents are verbally informed by healthcare professionals before and after birth about the importance of vitamin K supplementation and its benefits.
For healthcare professionals
Attend training on prevention of vitamin K deficiency bleeding (VKDB).
For neonatal unit
Develop a unit guideline on vitamin K supplementation in all infants.
Develop information material on the importance of vitamin K supplementation and its benefits for parents.
For hospital
Support healthcare professionals to participate in training on prevention of VKDB.
Provide facilities and equipment for milk expression.
For health service
Develop and implement a national guideline for vitamin K supplementation in all infants.
Raise awareness of the importance of vitamin k supplementation to effectively address common concerns and disinformation.
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Koletzko B, Uauy R. Nutritional Care of Preterm Infants. Freiburg im Breisgau: Karger, S; 2014.
September 2022 / Second edition / next revision: 2025
Recommended citation
EFCNI, Koletzko B, Buonocore G et al., European Standards of Care for Newborn Health: Prevention of vitamin K deficiency bleeding (VKDB) at birth. 2022.
