Vitamin K Deficiency In Newborn(VKDB):
Vitamin K Deficiency Bleeding (VKDB) previously known as Hemorrhage Disease of the Newborn (HDN), is a well-known clinical entity for over 100 years. Vitamin K is required for the synthesis of coagulation factors that prevent and control bleeding. All neonates have low levels of Vitamin K owing to poor transport of Vitamin K across placenta, low Vitamin K content in breast milk, and because gut colonization that is critical for its synthesis takes a few days to establish. There are three forms of VKDB.
a. Early VKDB presents with bleeding within 24 hours and occurs in newborn of mothers taking durgs such as anticoagulants, anticonvulsant (phenytoin, phenobarbitone) or anti-tubercular drug (Rifampicin). This condition can be prevented by administering Vitamin K to the mother receiving such drugs at least 24 hours before delivery, and/or replacing the offending drugs. Neonatal Vitamin K prophylaxis does not prevent this form of bleeding disorder.
b. Classical VKDB is the comments variant and presents after 24 hours but within the first week of life. The incidence of classical VKDB varies from 0. 01 to 1.5% depending upon the feeding pattern and Vitamin K prophylaxis status. Bleeding sites include the umbilical stump and GI tract, or the surgical wound (e.g. flowing circumcision). Intracranial hemorrhage (ICH) is. The incidence is higher in breastfed babies than in those who are formula-fed. Neonatal Vitamin K prophylaxis is effective in preventing classical VKDB.
c. Late VKDB is uncommon. The median incidence of late VKDB in infants who have not received any prophylaxis at birth is 30 per 100,000 births (range:4.4 to 80 ). Less developed countries have almost 10-hold higher incidence than developed nations (median: 80 vs. 7.2 per 100,000 births) with an incidence of 4.2 to 7.4 per 100,000 births. If manifests between 2-12 weeks of age primarily among breastfed infants who have received no or inadequate Vitamin K prophylaxis in addition, infants of antibiotics and those having intestinal malabsorption are at risk of this disorder. Intracranial hemorrhage is very common in this disorder and may be life threatening. Other sites of bleeding our skin. muscus membranes, and GI tract. Parenteral neonatal Vitamin K prevents late VKDB except in those with severe malabsorption syndrome.
Although, reliable estimates of VKDB from our country are not available, there is agreement among experts that the above description of the disease is applicable to our setting as well and measures should be taken for prevention.
A Corhrane review of 2000-2003 supports use of Vitamin K for all newborns. Vitamin K administration to infants soon after birth is an effective, safe and sustainable approach to preventing VKDB can be reduced to 1/1 million by the administration of vitamin K after birth.
Studies have soon a 27% relative risk reduction for classical Vitamin K deficiency bleeding with intramuscularly (IM) Vitamin K. The preferred method of Vitamin K prophylaxis is by intramuscular route. Oral Vitamin K prophylaxis request repeat does, hence not preferred. Intramuscular Vitamin K prophylaxis is a routine in neonatal practice in developed countries as well as in most tertiary care centres in our country.
VKDB is a significant threat to neonates. However, it can be prevented almost entirely by Vitamin K administration soon after birth. A single dose of intramuscular vitamin K is effective in the prevention of classic VKDB and in ameliorating late VKDB. Thus, Vitamin K prophylaxis would prevent morbidity and mortality due to bleeding in neonates.
Neonates Vitamin K prophylaxis is supported by WHO and professional bodies such as the American Academy of Pediatrics and Canadian Pediatric Society. The concerns regarding injection Vitamin K -enhancing cancer have been reported to be unfounded. Likewise, there is no risk of hyper bilirubinemia in newborn if used in the recommended dose.
Facility based newborn care training manual of MoHFW recommended that all newborn weighing more than 1000 gm should be given 1 mg of Vitamin K intramuscular after birth (i.e.the first hour by which infant should be in skin-to-skin contact with the mother and breastfeeding is initiated). For babies weighing less than 1000 gm, a dose of 0.5 mg is recommended.
Purpose of Vitamin K Prophylaxis:
The purpose of these guidelines is to
• Provide the rationale and define the protocols for administration of injection Vitamin K
• Promote the use of Injection Vitamin K in all newborns delivered in both public and private health facilities at all levels including medical colleges and tertiary care centres.
Recommendations :
1. All newborns delivered in health facilities at all levels including a sub-centre should receive Vitamin K prophylaxis.
2. Vitamin K prophylaxis is given as a single dose IM injection soon after birth. (Once the newborn is in skin-to-skin contact with the mother and breast feeding is initiated).
3. All newborns with birth weight of 1000 gm or more should be administered 1 mg of Vitamin K IM weighing list and 1000 gm should receive 0.5 mg dose.
4. Injection Vitamin K should be given IM antero-lateral aspect of the thigh using a 26 gauze needle and 1 ml syringe strictly following safe injection practices.
5. In case that needs urgent referral, Vitamin K prophylaxis may be given at the health facility where referral is made and should be recommended accordingly.
6. It should be a routine practice to record the date and those in the Labour Room/OT registers, neonatal case sheets, and referral/discharge slip.
7. Facility in-charge should ensure that medical and nursing staff will administer and document the use of prophylaxis Vitamin K newborns.
Bleeding in a newborn is a danger sign and may also occur due to causes other than Vitamin K deficiency. In case the newborn has any bleeding manifestation, appreciate referral and management should be instituted promptly as such cases may require blood product and supportive care.
8. All facilities will insure regular supplies or Vitamin K preparation, syringe, etc.
9. Records of injection Vitamin K administration should be validated from delivery room registers, case sheets, discharge, tickets, and referral registers routine monitoring visits. This information will be finally transferred into MCTS.
- Vitamin K : The recommended preparation for use is Vitamin K1 (Phytonadione injectable emulsion), which processes the same degree of activity as the naturally occurring in Vitamin K. The pharmacological action of Vitamin K is to promote the synthesis of Vitamin K-depended clotting factors (factor II, VII, IX and X) in the liver.
- Preparation: There are two commonly available preparation in the market:
a. 1 mg/1 ml
b. 1 mg/0.5 ml
3. States mein go for any of the two preparations depending on the availability. Under no circumstances should the state procure the preparation of injection Vitamin K containing 10 mg/ml.
4. Storage : Injection Vitamin K does not require refrigeration and can be stored at room temperature. As it is thermo stable, no additional expenditure on cold chain maintenance is needed.
5. Dosage: Injection Vitamin K 1 mg per 1 ml or 0.5 ml aqueous preparation.
6. Site of injection : Antero-lateral aspect of the thigh. In case any vaccination being given at birth such as Hep B then they should be given in separate thighs.
7. Logistics: Disposable Syringes (1 ml) and needles (26 G) for administering the injection.
Use of Injection Vitamin K Prophylaxis in Newborns :
Who will receive?
All newborns delivered in the facilities at all levels (both public and private)
Preparation to be used :
Injection Vitamin K1 (Phytonadione): a) 1 mg/1ml; b) 1 mg/0.5 ml
Dose to be given:
• Birth weight 1000 gm or more: 1mg
• Birth weight less than 1000 gm: 0.5 mg
Site and route of injection
• Antero-lateral aspect of the thigh, intramuscular injection
Who will give?
• Medical Officer, staff nurse or ANM
Where it will be given
• In the labour room
• It can be given in the post natal ward if missed in the labour room
• In case of referral the injections should be given at the SNCU/NBSU.
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Writer: Vandita Singh, Lucknow