EMHJ • Vol. 19 No. 5 • 2013 Eastern Mediterranean Health Journal La Revue de Santé de la Méditerranée orientale

Case report Change in hospital protocol regarding the use of vitamin K prophylaxis in newborns following a case of spontaneous subdural haematoma in a previously healthy 40-day-old infant M.M. K. Boujan1 and K.H.S.H. Sharef2

Introduction it is most common in breastfed infants Case report who did not receive vitamin K prophy- In 1894, Townsend described a self- laxis at birth. Vitamin K content is low A 40-day-old male infant presented to limited bleeding condition that usually in mature human milk and ranges from the casualty department of our hospital occurs 1–5 days after birth in patients 1–4 µg/L. Industrial contaminants in unconscious for 1 day duration. His with non-classic haemophilia [1]. The breast milk have been implicated in Glasgow coma scale was 4 (E1 V1 M2), term haemorrhagic disease of the new- promoting VKDB. More than half of with no eye opening to stimulation, no born was adopted to describe bleeding these infants present with acute intrac- crying to stimulation and movement disorders among neonates associated ranial haemorrhages [6]. In addition, only to painful stimulation and with with a traumatic birth or haemophilia infants who have intestinal malabsorp- left-sided hemiparesis. The patient was [2]. This diagnostic term has now been tion defects (cholestatic jaundice, cystic intubated and admitted to the intensive replaced with the term vitamin K defi- fibrosis, etc.) may also have late VKDB. care unit. His computerized tomogra- ciency bleeding (VKDB) because vita- The rate of late-onset VKDB, often phy (CT) brain scan showed a large min K deficiency is not the sole cause of manifesting as sudden central nervous right subdural haematoma (Figure haemorrhagic disorders in preterm and system haemorrhage, ranges from 4.4 to 1). No history or signs of trauma were term infants [3]. Vitamin K represents 7.2 per 100 000 births, according to re- observed. No blood disease history was a group of lipophilic and hydrophobic ports from Europe and Asia. Normally, reported by the family. vitamins that promotes the hepatic VKDB infants do not require surgical The child had had an uneventful synthesis of the certain clotting factors care but in rare cases, an infant may need antenatal care period. The mother had [4,5]. neurosurgical evaluation and treatment given birth in the hospital with a normal Although some controversy sur- [7,8]. Other conditions, such as those vaginal delivery of a full-term newborn rounds postnatal timing of the initial associated with short-bowel syndrome weighing 3 kg. The child did not re- haemorrhage, VKDB of the newborn and hepatobiliary disease may require ceive vitamin K injection. The child was is usually classified by 3 distinct time surgical evaluation. Intracranial bleed- breastfed. His mother gave no history periods after birth: early-onset VKDB ing is rare and is usually associated with of ingestion of any medications during usually occurs during first 24 hours after other causes of bleeding, particularly pregnancy. Parents gave a history of an birth and is very rare; classic VKDB thrombocytopenia; however, intracra- uncomplicated circumcision at the age usually occurs after 24 hours and as late nial haemorrhage has been reported in of 14 days. as the first week of life and is also rare; VKDB and can be fatal [9]. The child’s blood investigation and late-onset VKDB in a newborn who We present here a case of spontane- revealed the followings: prothrombin did not receive a vitamin K shot, and in ous subdural haematoma in a previously time (PT) 35.0 s (control 14.0 s), in- those of Asian descent, which usually healthy 40-day-old infant and discuss ternational normalized ratio (INR) 3.7, occurs between age 2–12 weeks but can the subsequent changes in our hospital activated partial thromboplastin time be seen as long as 6 months after birth. protocol regarding the use of vitamin K (aPTT) 35.0 s (control 32.0 s), haemo- The characteristics of VKDB are that prophylaxis in newborns. globin 5.2 g/dL. Blood film showed that

1School of Medicine, University of Sulaimani, Sulaimani, Iraq (Correspondence to M.M. K. Boujan: [email protected]). 2Paediatric Hospital, Sulaimani, Iraq. Received: 08/02/12; accepted: 21/03/12

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• Should it be given routinely to every newborn or just at-risk babies? • Is there a relationship between vita- min K and child oncology? • Which is the more effective route of administration: parenteral or oral? • Which treatment is more cost-effec- tive? • What if parents refuse vitamin K prophylaxis? The efficacy of neonatal vitamin K prophylaxis (oral or parenteral) in the prevention of early VKDB is firmly established. It has been the standard of care since the American Academy of Pediatrics (AAP) recommended it in 1961 [11]. A single dose of oral vitamin K has been used for neonatal Figure 1 Computerized tomography brain scan showing a large right subdural prophylaxis, the rate has decreased to haematoma 1.4 to 6.4 per 100 000 births. Paren- teral neonatal vitamin K prophylaxis red blood cells were normochromic prevents the development of late-onset Discussion VKDB in infants, with the rare excep- with anisocytosis, few spherocytosis tion of those with severe malabsorption cells, blister cells and slight polychro- Newborn infants are at risk for vitamin syndromes [7,8]. However, parents’ masia; white blood cells showed no K deficiency because their immature refusal of prophylaxis and an increasing primitive cells; and platelets count was liver does not efficiently utilize vitamin frequency of breastfeeding may be caus- 563 ×1000 /mm3 (normal 150–500 × K. In addition, they tend to have low ing a resurgence of VKDB in developed 1000). The conclusion from the blood vitamin K stores because of the low countries [5]. film analysis was severe anaemia and vitamin K content of breast milk, a The AAP Committee on Nutrition, that vitamin K deficiency should be sterile gut and poor placental transfer stated in its report recommendations excluded. of vitamin K. The risk of developing and conclusions that vitamin K1 is For the first and second day of VKDB is further increased by maternal to be administered for the preterm as ingestion of coumarin, certain antibi- admission fresh-frozen plasma was in- well as full-term newborns as a prophy- otics (i.e. cephalosporins) and some fused, and vitamin K injections (10 mg lactic treatment against spontaneous anticonvulsants during pregnancy [10]. once daily) and factor 7 were given. haemorrhage. The recommended dose Within 2 days the child’s haematology On 13 July 2006, before this current was 0.5–1.0 mg parenteral or 1.0–2.0 was as follows: INR had dropped to patient, we received another child of mg oral, with larger doses for children 1.04 (normal), PT was 14.9 s, (control the same age with the similar condi- of mothers on anticoagulants. It also 14.2 s) and aPTT was 31.3 s. tion, although the child was saved by a stated that it is ineffective to administer The child was prepared for cra- craniotomy and haematoma evacua- vitamin K to the mother herself [11]. niotomy and a haematoma was tion, nothing was done to address this The APP Committee on the Fetus evacuated. Postoperative CT showed problem at that time. and Newborn restudied the subject in resolution of most of the haematoma. Since 1961, awareness has been 2002–03 and published its policy state- The child regained full consciousness raised about the role of routine admin- ment that vitamin K1 should be given to 5 days after the operation; muscle istration of vitamin K to newborn babies all newborns as a single, intramuscular power of the left side was back to and its role in preventing the rather un- dose of 0.5–1 mg. They also recom- normal. There were no postoperative common condition of late-onset VKBD. mended that additional research should complications. The following questions concerning be conducted on the efficacy, safety, and On follow-up at 9 months, the child administration of vitamin K to new- bioavailability of oral formulations and was well and had normal milestones. borns were raised: optimal dosing regimens of vitamin K to

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prevent late VKDB. The committee also should receive vitamin K prophy- Fresh-frozen plasma may be considered advised that health care professionals laxis and that healthy newborn infants for moderate-to-severe bleeding [20]. should promote awareness among fam- should receive vitamin K either: by In case of intracranial haemorrhage, ilies of the risks of late VKDB associated intramuscular injection of 1 mg (0.1 evacuation of life-threatening haema- with inadequate vitamin K prophylaxis mL) of Konakion® MMI or 3× 2 mg toma should be considered [21]. from current oral dosage regimens, par- (0.2 mL) oral doses of Konakion® MM, ticularly for newborns who are breastfed given at birth; or at the time of newborn exclusively [12–14]. screening (usually at 3–5 days of age) Conclusion and Other countries developed their and in the 4th week [17]. recommendations own policies regarding recommending In the United Kingdom, the Na- vitamin K administration for newborn tional Institute for Health and Clinical Our experience in Sulaimani is that children, after extensive studies. Cana- Excellence, guideline CG37 (postnatal prior to the case reported here only da, for instance, through the Fetus and care and vitamin K) was that all parents at-risk babies (e.g. premature babies) Newborn Committee of the Canadian should be offered vitamin K prophylaxis were given 1 mg vitamin K in the form Pediatric Society, and the Committee for their babies to prevent the rare but of a single injection of vitamin K1 to on Child and Adolescent Health, Col- serious and sometimes fatal disorder of the thigh. Following this patient actions lege of Family Physicians of Canada, re- VKDB. Vitamin K should be adminis- taken in our hospital are now: affirmed in 2011 that vitamin K1 should tered as a single dose of 1 mg intramus- • routine injection of newborns with be given as a single intramuscular dose cular as this is the most clinically and vitamin K; of 0.5 mg (birth weight ≤ 1500 g or less) cost-effective method of administration. • reporting spontaneous bleeding con- or 1.0 mg (birth weight > 1500 g) to all If parents decline intramuscular vitamin ditions in children; and newborns within the first 6 h after birth. K for their baby, oral vitamin K should be • increasing the awareness of health For newborn infants whose parents offered as a second-line option. Parents professionals for this condition. refuse an intramuscular injection, an should be advised that oral vitamin K We recommend expanding this oral dose of 2.0 mg vitamin K1 can be must be given according to the manu- protocol to other parts of Kurdistan and given at the time of the first feeding. This facturer’s instructions for clinical efficacy hospitals of Iraq. A wide prospective should be repeated at 2–4 weeks and and will require multiple doses [18]. study on Iraqi babies and their parents 6–8 weeks of age [15]. A large national study, the United should be done regarding the effect of In New Zealand the 2000 consensus Kingdom Childhood Cancer Study, this prophylactic regimen preventing statement recommended the intramus- included an updated pooled analysis future VKDB in our country. The fol- cular route of administration for vitamin with data for 7017 children (1174 with lowing points should be addressed: K given at birth (for term babies 0.5–1 leukaemia). It found no association mg soon after birth; for preterm babies between intramuscular vitamin K and • parental consent to administration of 0.5 mg soon after birth). If parents do not any diagnostic group. The authors con- vitamin K to their newborn children; consent to intramuscular injection but cluded that in the light of all available • circumstances when babies miss their consent to oral vitamin K, this needs to be evidence, chance was the most likely prophylactic; and given according to the following regime: explanation for early findings regarding • education for midwives about the 2 mg oral soon after birth, 2 mg oral at the link between vitamin K and child- seriousness and types of this VKDB, 3–7 days, 2 mg oral at 6 weeks [16]. hood cancer [19]. These guidelines for in case of house delivery. In Australia, the National Health management of child with this type of and Medical Research Council joint bleeding were to immediately admin- Consent: Written informed consent statement and recommendations on ister vitamin K subcutaneously (hold was obtained from the patient’s parents Vitamin K administration to newborn pressure on the site) for any infant in for publication of this case report and infants to prevent VKDB in infancy whom VKDB is suspected or who has the accompanying image. in 2010 was that all newborn infants serious, unexplained neonatal bleeding. Competing interests: None declared.

References

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