Vitamin K deficiency bleeding 3
The third BPSU study on Vitamin K deficiency bleeding ran from January 2001 to January 2003. The study intended to investigate the impact of changes in vitamin K prophylaxis regimens and the introduction of vitamin K MM on the prevalence of VKDB. Whether failures to achieve the planned prophylaxis regimen remained a major cause of morbidity, and if newer regimens and preparations reduce the risk of VKDB when there was co-existing liver disease. It also investigated the reasons for vitamin K not being given and whether there were delays in presentation.
Lead investigator
Dr Andrew McNinch
About the study
The BPSU survey of Haemorrhagic Disease of the Newborn 1988-90 clearly demonstrated that the condition remained a cause of death and handicap, which was preventable by vitamin K prophylaxis. Intramuscular prophylaxis provided more reliable protection than oral in the doses then used. In 1992, there was publicity of studies suggesting a link between vitamin K prophylaxis administered to neonates and the subsequent development of childhood cancer.
Subsequent studies provided some reassurance, but it may have never been possible to exclude a 10% increase in risk. As a result, paediatricians had repeatedly reviewed their prophylaxis recommendations, and many parents were anxious about the use of vitamin K in any form.
In 1996, Konakion MM Paediatric became licensed for oral prophylaxis and was increasingly used. There was no uniformity of practice, and so continued surveillance for VKDB remains essential.
The first and second BPSU surveys of Vitamin K Deficiency Bleeding (VKDB) were carried out between 1989-1990 and 1993-1994. They demonstrated that VKDB was occurring in the British Isles despite widespread use of vitamin K prophylaxis, and VKDB was a significant cause of preventable mortality and morbidity.
Vitamin K was given in four commonly used but different regimens. In 1993, some units gave no routine prophylaxis, some gave a single oral dose, some gave multiple oral doses, and some gave intramuscular vitamin K to all infants. The relative risk of bleeding in infancy was maximum in the first and minimum in the last of these groups, with dramatic differences across the groups; babies given no prophylaxis (including those whose parents have refused it) were eighty times more likely to bleed than those given intramuscular prophylaxis.
Errors in the administration of the planned regimen or parental refusals would tend to mask these differences. Surveys of vitamin K prophylaxis in the United Kingdom in 1988 and 1993 showed an increase in the number of infants receiving prophylaxis orally. Since then, the number of infants receiving multiple oral prophylaxis regimens with Konakion K MM (Roche) or other preparations has increased. Unsuspected liver disease continued to be a high-risk factor for VKDB.
Duration
January 2001 – January 2003
Published papers
McNinch A, Busfield A, Tripp J. Vitamin K deficiency bleeding in Great Britain and Ireland: British Paediatric Surveillance Unit Surveys, 1993 94 and 2001-02. Arch Dis Child. 2007 Sep;92(9):759-66. doi: 10.1136/adc.2006.104752. Epub 2007 May 30. PMID: 17537761; PMCID: PMC2084011.
BPSU 17th Annual report 2002 – 2003