Vitamin K for newborns is given from birth to prevent a rare but serious condition: spontaneous bleeding, sometimes in the brain. For a baby born at full term, the oral schedule currently used in France consists of three 2 mg doses: at birth, between day 4 and day 7, then at 1 month. The third dose mainly concerns breastfed babies.
This schedule was simplified in 2014, yet many parents still don't know it well. Here is what health authorities and medical societies say.
Why does a newborn need vitamin K?
Vitamin K is essential for producing several blood-clotting factors. Newborns have very little of it at birth, and breast milk provides only a small amount. Without a supplement, some babies develop haemorrhagic disease of the newborn.
In its update published in September 2017 in Archives de pédiatrie, the Société française de néonatologie (the French neonatology society) points out that this disease, although rare, can cause bleeding in the brain, liver or adrenal glands. It also stresses that prevention relies on giving vitamin K1 from birth.
Three forms depending on age
- The early form, in the very first hours of life.
- The classic form, during the first week.
- The late form, between a few weeks and a few months of age, and the most feared.
What are the figures without prevention?
The US Centers for Disease Control and Prevention (CDC) published reference data in November 2013. Without prophylaxis, the early and classic forms affect 0.25% to 1.7% of births. The late form affects 4.4 to 7.2 infants per 100,000.
According to the CDC fact sheet for healthcare providers, reviewed on 17 January 2025, 30% to 60% of late-form cases present as bleeding inside the skull. When vitamin K is given at birth, the late form drops below 1 case per 100,000 infants. The CDC estimates that a baby who does not receive the vitamin K injection is 81 times more likely to develop the disease.
Vitamin K for newborns: what is the schedule in France?
The summary of product characteristics for infant vitamin K1 was updated on 22 April 2025. It describes two options for a healthy full-term newborn, born at 36 weeks or later.
- By mouth: 2 mg at or shortly after birth, 2 mg between day 4 and day 7, then 2 mg at 1 month.
- By intramuscular injection: a single 1 mg dose at or shortly after birth.
For a baby fed exclusively on infant formula, the third oral dose can be left out, as infant formulas are fortified with vitamin K. For a breastfed baby, it is still needed.
The Société française de néonatologie recommends an equivalent schedule: three 2 mg oral doses, at birth, on leaving the maternity unit and at 1 month. In its March 2014 recommendation on discharge from the maternity unit, the Haute Autorité de santé (HAS, the French national health authority) lists giving vitamin K1 among the criteria for early discharge. It also includes supplementing breastfed babies in the follow-up once the family is back home.
What changed in 2014
In September 2014, the Agence nationale de sécurité du médicament (ANSM, the French medicines agency) sent healthcare professionals information about the change in dosage. This followed a European harmonisation. Previously, breastfed babies received a dose every week for as long as they were exclusively breastfed. These weekly doses were dropped and replaced by a single dose at 1 month.
Many parents still have the old schedule in mind, passed on by family and friends. The child's health record book and the discharge prescription are what count.
What about a premature baby?
Premature babies follow an adapted schedule decided by the neonatal team. The Société française de néonatologie recommends an oral dose of 2 mg a week until corrected term for babies weighing more than 1,500 g. Below 1,500 g, the weekly dose is 1 mg until they reach that weight, then 2 mg. Figures on premature birth in France are set out in our article on premature birth in France, and how to read corrected age in our article on calculating corrected age.
Declining vitamin K: what has been observed
In the United States, the CDC described four late-form cases in 2013 in infants in Tennessee whose parents had declined prophylaxis. The state had recorded no confirmed cases between 2007 and 2012, out of 493,259 births. In Nashville hospitals, around 3.4% of newborns did not receive vitamin K. In the birthing centres studied, this share reached 28%.
The reasons parents gave were fear of a leukaemia risk and a wish to avoid ‘toxins’. In France, the oral route is the most common in maternity units and avoids the injection. It does, however, require all three doses to be given.
Signs that mean you should see a doctor
Bleeding can show up in subtle ways. See a doctor promptly if your baby has:
- bleeding that won't stop, from the umbilical cord, the nose or a needle prick;
- unexplained bruises, or blood in their stools or vomit;
- paleness, unusual drowsiness, repeated vomiting;
- jaundice that lasts beyond the first few weeks.
Persistent jaundice should always be reported, as we explain in our article on newborn jaundice.
Vitamin K and other supplements
Vitamin K should not be confused with vitamin D, which is given every day during the first years. Our article on vitamin D for infants sets out the dosage rules. For breastfeeding mums, our guide to the nursing pillow covers getting comfortable day to day, and our article on breastfeeding in France brings together the official data.
Sources
- Hascoët J.-M., Picaud J.-C., Lapillonne A. et al., Société française de néonatologie, ‘La vitamine K chez le nouveau-né : mise à jour des recommandations’, Archives de pédiatrie, vol. 24, no. 9, September 2017.
- Base de données publique des médicaments (French public medicines database), Vitamine K1 Cheplapharm 2 mg/0.2 ml nourrissons, summary of product characteristics updated on 22 April 2025.
- ANSM, letter to healthcare professionals on the change in dosage of Vitamine K1 Roche 2 mg/0.2 ml nourrissons, September 2014.
- Haute Autorité de santé, Sortie de maternité après accouchement, good practice recommendation, March 2014.
- CDC, Late Vitamin K Deficiency Bleeding in Infants Whose Parents Declined Vitamin K Prophylaxis — Tennessee, 2013, MMWR, 15 November 2013.
- CDC, How to Protect Babies from Life-threatening Bleeding, fact sheet for healthcare providers, reviewed on 17 January 2025.
