Vitamin K deficiency bleeding in Australian infants 1993–2017: an Australian Paediatric Surveillance Unit study

Abstract

ObjectiveTo undertake surveillance of vitamin K deficiency bleeding (VKDB) in Australia from 1993 to 2017, during a time of change to national recommendations and available vitamin K formulations.MethodsPaediatricians reported cases of VKDB in infants aged <6 months and provided demographic, clinical and biochemical information via the Australian Paediatric Surveillance Unit.Results58 cases were reported, of which 5 (9%) were early, 11 (19%) classic and 42 (72%) late VKDB. 53 (91%) were exclusively breast fed. Seven (12%) received oral prophylaxis, the majority (86%) of whom did not receive all three recommended doses. The overall reported incidence was 0.84 per 100 000 live births (95% CI: 0.64 to 1.08) and the incidence of late VKDB was 0.61 per 100 000 live births (95% CI: 0.44 to 0.82), which are similar to rates reported by other countries where intramuscular vitamin K is recommended. VKDB rates were significantly higher (2.46 per 100 000 live births; 95% CI: 1.06 to 4.85) between 1993 and March 1994 when oral prophylaxis was recommended (p<0.05). Vitamin K was not given to 33 (57%) cases, primarily due to parental refusal, and the number of parental refusals increased significantly after 2006 (p<0.05). There were six deaths, all due to intracranial haemorrhage, and three associated with home delivery and parental refusal of vitamin K.ConclusionsIncidence rates of VKDB in Australia are among the lowest in the world; however, we have identified an increasing trend of parental refusal. Ongoing surveillance and educational campaigns for health professionals and parents are needed to prevent VKDB.

Delivering neonatal vitamin K prophylaxis: the continuing need for surveillance and vigilance

“…Zurynski et al 3 report that the overall VKDB incidence in Australia over the 24-year study period was 0.84 per 100 000 live births, which is comparable with the overall incidence of 0.64 in the last British 2006–2008 survey. However, the Australian data include the higher incidence of 2.5 per 100 000 during the first 15 months when oral prophylaxis (three doses of 1 mg) was in place.…”

“…A disturbing finding of the Australian data is that parental refusal of prophylaxis rose significantly over the study period accounting for 63% of VKDB cases from 2006 to 2017 compared with 32% from 1993 to 2005, rising to 85% for home deliveries 3. In the British surveys of 2000–2002 and 2006–2008, parental refusal accounted for 57% and 46% of VKDB cases, respectively.…”

“…In this context, Zurynski et al 3 report the data of the Australian Paediatric Surveillance Unit for the incidence of VKDB from 1993 to 2017. Before 1993, there had been no national surveillance of VKDB in Australia, and the recommendations of the National Health and Medical Research Council (NHMRC) had been for a single intramuscular injection of 1 mg vitamin K1.…”

“…In Australia, the oral regimen introduced in January 1993 was the same as in Germany at that time, namely three 1 mg doses in total, given at birth, 1 week and 1 month. However, within 15 months, there had been eight cases of VKDB in infants receiving oral vitamin K1, and in April 1994, the NHMRC reverted to their previous recommendation of intramuscular prophylaxis 3. From the year 2000, the Australian data3 also reflect a formulation change from Konakion Cremophor to mixed micellar Konakion MM accompanied by a posological increase of vitamin K1 from 1 mg to 2 mg for oral administration.…”

“…A reassuring finding of the Canadian study is that 99.3% of neonates received the recommended intramuscular injection and only 0.3% of parents declined prophylaxis; the remaining 0.4% received vitamin K orally 4. A major message is that parental refusal is now the most important issue3 but is less likely when units also offer oral prophylaxis.…”