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Table 4 Summary of existing recommendations

From: Vitamin K prophylaxis in newborns

Source Ref Date General recommendations for use of prophylactic vitamin K in newborns
WHO [3, 5] 2012, updated in 2017 “All newborns should be given 1 mg of vitamin K intramuscularly (IM) after birth (i.e. after the first hour by which the infant should be in skin-to-skin contact with the mother and breastfeeding should be initiated).”
(Strong recommendation, moderate quality evidence)
“Neonates requiring surgical procedures, those with birth trauma, preterm newborns, and those exposed in utero to maternal medication known to interfere with vitamin K are at especially high risk of bleeding and must be given vitamin K (1 mg IM).”
(Strong recommendation, moderate quality evidence)
[4] 2015 “Give 1 mg of vitamin K IM to all newborns, one hour after birth”
PrevInfad [6] 2010 After birth, prophylactic vitamin K should be administered to prevent HDN (Strong recommendation).
After birth, IM administration of 1 mg of vitamin K is recommended to prevent classical HDN (Strong recommendation).
After birth, IM administration of 1 mg of vitamin K is recommended to prevent late HDN (Weak recommendation).
In case of parents who do not want IM administration, oral administration of 2 mg of vitamin K is recommended followed by 1 mg weekly until 12 weeks of age in totally or partially breastfed infants (Weak recommendation).
For preterm babies:
• < 32 weeks and > 1000 g: 0.5 mg IM or IV
• < 1000 g independently of gestational age: 0.3 mg IM or IV
(Weak recommendation)
NICE [7] 2015 “All parents should be offered vitamin K prophylaxis for their babies to prevent the rare but serious and sometimes fatal disorder of vitamin K deficiency bleeding.”
“Vitamin K should be administered as a single dose of 1 mg intramuscularly as this is the most clinically and cost-effective method of administration.”
“If parents decline intramuscular vitamin K for their baby, oral vitamin K should be offered as a second-line option. Parents should be advised that oral vitamin K must be given according to the manufacturer’s instructions for clinical efficacy and will require multiple doses.”
Note: These recommendations were established in 2006 when the first clinical guideline was published, but updated in 2015.
CDC [8] Updated 2018 One shot intramuscularly in the thigh just after birth, can be delayed up to 6 h after birth.
AAP [9, 10] 2003 (updated 2020) “Vitamin K1 should be given to all newborns as a single, intramuscular dose of 0.5 to 1 mg.”
“Additional research should be conducted on the efficacy, safety, and bioavailability of oral formulations and optimal dosing regimens of vitamin K to prevent late VKDB.”
“Health care professionals should promote aware- ness among families of the risks of late VKDB associated with inadequate vitamin K prophylaxis from current oral dosage regimens, particularly for newborns who are breastfed exclusively.”
ESPGHAN [16] 2016 “Healthy newborn infants should either receive:
(a) 1 mg of Vitamin K1 by IM injection at birth, OR
(b) 3 × 2 mg Vitamin K1 orally at birth, at 4 to 6 days and at 4 to 6 weeks, OR
(c) 2 mg Vitamin K1 orally at birth, and a weekly dose of 1 mg orally for 3 months.”
“The oral route is not appropriate for preterm infants and for newborns who are unwell, have cholestasis or impaired intestinal absorption or are unable to take oral vitamin K, or those whose mothers have taken medications that interfere with vitamin K metabolism.”
CADTH [17] 2015 “Single intramuscular dose of vitamin K (0.5 mg for birthweight ≤1500 g or 1.0 mg for birthweight ≥1500 g) should be administered to all newborns within the first 6 h after birth.”
“If intramuscular vitamin K is refused by parents, an oral dose of 2 mg vitamin K was recommended at the time of first feeding, followed by a second dose at 2 to 4 weeks, and a third dose at 6 to 8 weeks.”
  1. Abbreviations: AAP American Academy of Pediatrics; CADTH Canadian Agency for Drugs and Technologies in Health; CDC Centers for Disease Control and Prevention; ESPGHAN European Society for Paediatric Gastroenterology Hepatology and Nutrition; HDN haemorrhagic disease of the newborn; IM intramuscular; IV intravenous; NICE National Institute for Health and Care Excellence; PrevInfad PrevInfad workgroup from the Spanish Association of Primary Care Pediatrics; VKDB vitamin K deficiency bleeding; WHO World Health Organization