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Vitamin K prophylaxis has been shown to reduce sub-clinical deiciency in the irst week of life measured as the presence of a protein induced by vitamin K deiciency,
or PIVKA. here was no signiicant diference between oral or IM vitamin K on subclinical deiciency in the irst week of life. Studies have also looked as prothrombin
time PT but none of the studies that included infants had a PT outside the normal range in the intervention and control groups. Two studies, which examined the efect
of vitamin K prophylaxis on prothrombin complex deiciency, reported that IM prophylaxis reduced deiciency by 72 and oral prophylaxis by 50.
Data from two observational studies showed that vitamin K prophylaxis – single dose administered at birth by either IM or oral route – reduces the incidence of late
VKDB substantially; prophylaxis by IM route was signiicantly better about 97 than that by the oral route 65–83 in reducing the incidence of late VKDB. Although
late VKDB is rare, about one third of infants with this condition die or have severe handicaps. he NNT estimated from two observational studies incidence with no
vitamin K prophylaxis, 6 per 100 000 is about 18 000. If the incidence were 30 per 100 000, the number needed to treat to prevent a case of late VKDB is about 3000. he
quality of this evidence was graded as low or very low.
5.1.2 Benefits and risks
Benefits Vitamin K prophylaxis signiicantly reduces the risk of bleeding in neonates. Twenty
neonates undergoing circumcision need to be given prophylaxis to prevent one case of bleeding ater circumcision. About 80 neonates need to be given prophylaxis to
prevent one case of non-circumcision bleeding. Late VKDB can be prevented with vitamin K prophylaxis – one case prevented per about 3000 infants treated.
Risks he irst report of a potential association between vitamin K prophylaxis and
childhood cancer appeared in 1990. Subsequent research has not substantiated this concern.
5.1.3 Acceptability and feasibility
Vitamin K intervention is efective but the disease it prevents is relatively rare. Current practice in most developed countries is to give vitamin K prophylaxis to
all newborn babies ater birth. he cost of the medicine itself is US 0.195 per 1 mg injection. Costs of the syringe and needle and the supply of vitamin K, etc. would be
additional. he costs for routine vitamin K administration may not be justiiable in low-resource settings.
5.2 Prophylactic antibiotics in newborns at risk of infection
A neonate with risk factors for infection i.e. membranes ruptured 18 hours before delivery, mother had fever 38 °C before delivery or during labour, or amniotic
luid was foul smelling or purulent should be treated with prophylactic antibiotics
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ampicillin IM or IV and gentamicin for at least 2 days. Ater 2 days, the neonate should be reassessed and treatment continued only if there are signs of sepsis or a
positive blood culture.
Strong recommendation, Very low quality evidence
he panel made this recommendation based on expert consensus as there was very low quality evidence that the intervention may prevent neonatal sepsis. here was no
evidence available to evaluate harms and the risk of increasing antibiotic resistance, injection safety, and keeping a baby in hospital up to or for 5 days.
5.2.1 Evidence and summary of findings
he Cochrane review included only two studies. here were no deaths reported in the intervention or control groups in either of the studies. Similarly, one of the studies
found no cases of sepsis in either of the groups. he quality of evidence from these two single studies is very low
see GRADE table A7.2 .
None of the infants who participated in the trials died in the neonatal period. One of the studies Wolf, 1976 reported four cases of neonatal sepsis, all of which
occurred in the control selective treatment group. his diference was statistically non-signiicant 49 participants, RR = 0.12, 95 CI 0.01 to 2.04.
Data are insuicient to provide evidence of a beneicial efect of immediate prophylactic antibiotic compared to selective use of antibiotics on either neonatal
mortality or on incidence of neonatal sepsis. he two trials were small and underpowered to detect any efect on the two outcomes of interest. he overall quality
of evidence is very low.
5.2.2 Benefits and risks
