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Eyes and Thighs Nisha Nair And Socorro Quimson The University of Texas Medical Branch School Of Nursing Neonatal AHA GNRS 5303.

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Presentation on theme: "Eyes and Thighs Nisha Nair And Socorro Quimson The University of Texas Medical Branch School Of Nursing Neonatal AHA GNRS 5303."— Presentation transcript:

1 Eyes and Thighs Nisha Nair And Socorro Quimson The University of Texas Medical Branch School Of Nursing Neonatal AHA GNRS 5303

2 Objectives  Discuss the history and origin of Erythromycin and Vitamin K prophylaxis of the newborn.  Examine and Learn about Texas Administrative Code for the prophylaxis against Ophthmalmia Neonatorum (ON).  Describe Ophthalmia Neonatorum and Vitamin K Deficiency Bleeding (VKBD) in detail and their negative long term consequences.  Review Erythromycin and Vitamin K function and usage in practice.  Discuss evidence base studies of Erythromycin and Vitamin K prophylaxis in preventing ON and VKDB respectively.

3 Eye Prophylaxis in the Newborn

4 Origin of Testing/Delivery Becoming Mandatory In Texas  The use of erythromycin eye ointment in newborns has its roots in the late 1800s. During that time period, approximately 10% of newborns born in maternity hospitals across Europe developed ophthalmia neonatorum (ON). This means that during the late 1800s, before antibiotics were discovered, 0.3% of infants (3 out of 1,000) were blinded from ON (Dekker, 2012, para. 1)  In 1881, a physician named Carl Crede found that by putting silver nitrate in the eyes of newborn babies, Ophthalmia Neonatorum can be prevented. The incidence of ON in Dr. Crede’s hospital went from 30-35 cases per year to 1 case in the first six months he started using silver nitrate (Dekker, 2012, para. 2).

5 Origin of Testing/Delivery Becoming Mandatory In Texas  In 1940’s and 1950’s when antibiotics became available, Penicillin was used as prophylaxis for Ophthalmia Neonatorum but abandoned because it was found out that topical use of penicillin caused patient’s allergy to penicillin. Furthermore, in the late 1970’s many strains N. Gonorrhea were resistant to penicillin.  In 1975 Infection of neonates with chlamydia trachomatis has become more common than N. Gonorrhea. There was a concern that silver nitrate is not effective in preventing infection with Chlamydia.  Povidone –iodine solution has been shown to be more effective and cause less irritation than erythromycin ointment. But is not yet approved for this use by the USA Food and Drug Administration.

6 Origin of Testing/Delivery Becoming Mandatory In Texas  Newborn eye prophylaxis to prevent neonatal gonorrhea and chlamydia infections is mandatory in Texas.  DSHS rules (and CDC guidelines) allow only three medications for this use:  Silver nitrate ophthalmic preparation – no longer available  Tetracycline ophthalmic preparations - no longer available; and  Erythromycin ophthalmic ointment and drops. The drops don’t appear to be available.

7 Origin of Testing/Delivery Becoming Mandatory In Texas Texas Administrative Code Rule 97.136 : Prophylaxis Against Ophthalmia Neonatorum ( b) Failure to perform is a Class B misdemeanor under the Texas Health and Safety Code, §81.091(g). (c) The department may provide an approved prophylaxis without charge to health-care providers if the newborn's financially responsible adult is unable to pay. The health-care provider shall not charge for the prophylaxis that is received free of charge from the department. (d) Midwives shall follow the additional requirements in Texas Health and Safety Code, §81.091.

8 Origin of Testing/Delivery Becoming Mandatory In Texas Texas Administrative Code Rule 97.136 : Prophylaxis Against Ophthalmia Neonatorum (a) A physician, nurse, midwife, or other person in attendance at childbirth shall apply, or cause to be applied, to the child's eyes a 0.5% ophthalmic erythromycin ointment in each eye within two hours after birth. If this ointment is not available due to a disruption in distribution or manufacturing, a physician, nurse, midwife, or other person subject to this section shall apply or cause to be applied to the child's eyes an alternative treatment included in guidance issued by the Department of State Health Services (department) or the Centers for Disease Control and Prevention.

9 Detail Each Part Of The Testing/Care ; Its Function And Use In Practice  Ophthalmia Neonatorum is a type of bacterial conjunctivitis or infection of the eyelid tissues, occurring among newborns during delivery. The problem arises when the eyes of a newborn get infected while passing through the birth canal of a woman suffering from Chlamydia trachomatis or Neisseria gonorrhea.  This medical condition is also referred to as: Neonatal conjunctivitis Or Conjunctivitis of the newborn.  Approximately 15% to 20% of babies will develop conjunctivitis in the first weeks of life(Gleason & Devaskar, 2012, p. 304)

10 Detail Each Part Of The Testing/Care ; Its Function And Use In Practice  The etiology of ophthalmia neonatorum / neonatal conjunctivitis can be chemical or microbial. Although several noninfectious and infectious agents can inflame the conjunctiva, the more common causes of neonatal conjunctivitis are silver nitrate solution and chlamydial, gonococcal, staphylococcal, and herpetic infections.  Chemical conjunctivitis secondary to silver nitrate solution application usually occurs in the first day of life, disappearing spontaneously within 2-4 days.  Chlamydia is the most common infectious agent that causes ophthalmia neonatorum in the United States (2-40% of neonatal conjunctivitis is caused by Chlamydia).  Neisseria gonorrhoe is a gram-negative diplococcus and is potentially the most dangerous and virulent infectious cause of neonatal conjunctivitis. Similar to chlamydia, the reservoir of N gonorrhoeae is the mother of the infant and is acquired during birth.

11 Detail Each Part Of The Testing/Care ; Its Function And Use In Practice  Newborn prophylaxis with eye ointment is currently recommended by multiple health organizations in the United States, including the U.S Preventative Services Task Force, the American Association of Family Physicians, and the American Academy of Pediatrics.  Prophylactic regimens using 1.0% tetracycline or 0.5% erythromycin ophthalmic ointment are considered equally effective in the prevention of gonococcal ophthalmia neonatorum; however, the only drug approved by the U.S. Food and Drug Administration for this indication is 0.5% erythromycin ophthalmic ointment. Tetracycline ophthalmic ointment and silver nitrate are no longer available in the United States. A 2.5% solution of povidone-iodine may be useful in preventing ophthalmia neonatorum, but it has not been approved for use in the United States at this time.

12 Detail Each Part Of The Testing/Care ; Its Function And Use In Practice Erythromycin Ophthalmic Ointment USP, 0.5% (Sterile) Description  Erythromycin Ophthalmic Ointment USP belongs to the macrolide group of antibiotics. The sterile ophthalmic ointment flows freely over the conjunctiva. Erythromycin base, as crystals or powder, is slightly soluble in water, moderately soluble in ether, and readily soluble in alcohol or chloroform. Erythromycin is an antibiotic produced from a strain of Streptomyces erythraeus. It is basic and readily forms a salt when combined with an acid. Each gram contains Erythromycin USP 5 mg in a sterile ophthalmic base of mineral oil and white petrolatum. (Bausch & Lomb Incorporated, 2008, p. 1)

13 Detail Each Part Of The Testing/Care ; Its Function And Use In Practice Microbiology  Erythromycin inhibits protein synthesis without affecting nucleic acid synthesis. Erythromycin is usually active against the following organisms in vitro and in clinical infections: Streptococcus pyogenes (group A β- hemolytic), Alpha-hemolytic streptococci (viridans group); Staphylococcus aureus, including penicillinase- producing strains (methicillin-resistant staphylococci are uniformly resistant to erythromycin); Streptococcus pneumoniae; Mycoplasma pneumoniae (Eaton Agent, PPLO); Haemophilus influenzae (not all strains of this organism are susceptible at the erythromycin concentrations ordinarily achieved); Treponema pallidum; Corynebacterium diphtheriae; Neisseria gonorrhoeae; Chlamydia trachomatis. (Bausch & Lomb Incorporated, 2008, p. 1)

14 Detail Each Part Of The Testing/Care ; Its Function And Use In Practice Indications and Usage  For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin.  For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis.  The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrhoeae is not established.  For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants. (Bausch & Lomb Incorporated, 2008, p. 1)

15 Detail Each Part Of The Testing/Care ; Its Function And Use In Practice Dosage and Administration  In the treatment of superficial ocular infections, erythromycin ophthalmic ointment approximately 1 cm in length should be applied directly to the infected eye(s) up to six times daily, depending on the severity of the infection.  For prophylaxis of neonatal gonococcal or chlamydial ophthalmia, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant. (Bausch & Lomb Incorporated, 2008, p. 1)

16 Detail Each Part Of The Testing/Care ; Its Function And Use In Practice  Adverse Reactions  The most frequently reported adverse reactions are minor ocular irritations, redness, and hypersensitivity reactions.  How Supplied  Sterile Erythromycin Ophthalmic Ointment USP, 0.5% is available as follows:  3.5 g (1/8 oz) sterile tamper-resistant tube  Do not use if cap and neck ring are not intact  Do not use if bottom ridge of tube cap is exposed  Storage  Store at 20° to 25°C (68° to 77°F)  Avoid excessive heat.  Protect from freezing. (Bausch & Lomb Incorporated, 2008, p. 1)

17 Pertinent Research Theories And Evidence Based Practice  Since the introduction of Credé’s method in 1881, instilling one eye drop of 1% silver nitrate at birth to reduce ophthalmia neonatorum has been practiced worldwide.  In1996, the efficacy of prophylactic agents other than silver nitrate was explored in a non-randomized clinical trial in Kenya. Isenberg and colleagues compared the benefits of povidone-iodine prophylaxis with the well-established benefits of silver nitrate and erythromycin ophthalmic prophylaxis. Isenberg concluded that all three agents were equally effective in the prevention of gonococcal infection, but povidone-iodine prophylaxis resulted in significantly fewer cases of ophthalmia neonatorum overall and fewer cases of C trachomatis infections in infants as well.

18 Pertinent Research Theories And Evidence Based Practice  A study compared the efficacy of erythromycin ophthalmic ointment versus 1% silver nitrate drops for the prevention of neonatal conjunctivitis or from Chlamydia trachomatis. The organism was isolated from the cervix of 67 (12%) of 572 pregnant women. They gave birth to 559 infants who were randomly assigned to either prophylaxis immediately after birth. Thirty-six of 60 infants born to Chlamydia-positive women received silver nitrate; 24 received erythromycin. Twelve (33%) of the 36 infants who received silver nitrate had chlamydial conjunctivitis, but none of the 24 infants who received erythromycin did (The journal of the American medical association [JAMA], 1980, para. 1).

19 Pertinent Research Theories and Evidence Based Practice  A meta-analysis of the efficacy of ocular prophylactic agents used for the prevention of gonococcal and chlamydial ophthalmia neonatorum had shown that Erythromycin decrease the risk of Chlamydial ophthalmia neonatorum when compared to silver nitrate (Darling & McDonald, 2010, para. 3)  A randomized Controlled Trials on Efficacy of Prophylaxis of Conjunctivitis in Newborn by Bell et all on 1993,USA had shown that compared to no prophylaxis, Erythromycin had lower rate of conjunctivitis (Moseley, 2003, p. 72).

20 Pertinent Research Theories And Evidence Based Practice  The American Academy of Pediatrics recommends prophylaxis of newborn infants with a 0.5% erythromycin ophthalmic ointment or 1% tetracycline ophthalmic ointment (which is no longer available in the United States). Each is available in single-dose forms. Use of povidone-iodine in a 2.5% solution may also be useful, but a product for this purpose is not available in the United States. Prophylaxis should be provided to all infants shortly after birth. A monitoring system to ensure prophylaxis is provided to all infants and in a timely manner is recommended. Additionally, infants born to mothers with known clinical gonorrhea infection require intravenous or intramuscular antibiotics, as topical prophylaxis alone is inadequate for these infants.

21 Pertinent Research Theories And Evidence Based Practice  The Centers for Disease Control and Prevention recommend a single application of either 0.5% erythromycin or 1% tetracycline ointment into both eyes as soon as possible after birth, with use of single-use tubes or ampoules preferable to multiple-use tubes. Establishment of a monitoring system to ensure that all infants receive prophylaxis is recommended.  In 2003, the World Health Organization recommended the application of either a 1% silver nitrate solution or 1% tetracycline ointment into the eyes of all infants at the time of birth. It also recommends additional treatment for those infants born to mothers with gonococcal infection.

22 Pertinent Research Theories And Evidence Based Practice  In 1994, the Canadian Task Force on Preventive Health Care released guidelines for gonococcal ophthalmia neonatorum, recommending universal prophylactic use of 1% silver nitrate drops or 1% tetracycline or 0.5% erythromycin ointment within one hour of birth in single-dose ampules.  In January 2009, the Canadian Pediatric Society reaffirmed its 1983 published statement on ophthalmia neonatorum, recommending that all infants receive prophylaxis with silver nitrate, tetracycline, or erythromycin as soon as possible after birth to reduce the risk of gonococcal ophthalmia neonatorum

23 Ophthalmia Neonatorum Long Term Outcome  Identifying and treating the gonococcal ophthalmia neonatorum is important because it can result in corneal scarring, ocular perforation and blindness. r  There is convincing evidence that blindness due to gonococcal ophthalmia neonatorum has become rare in the United States since the implementation of universal prophylaxis of newborns.

24 Vitamin K Prophylaxis in the Newborn

25 History Of Vitamin K Use To Prevent Hemorrhagic Disease Of The Newborn.  At the start of the 20th century the mechanisms of haemostasis were virtually unknown. Townsend had coined the term 'Haemorrhagic disease of the newborn' (HDN) in 1894 but it was not until the discovery of vitamin K ('Koagulation vitamin') by Dam and others in the 1930s that the condition became understood, allowing treatment and prophylaxis. Methods of prophylaxis (preparations used, doses and routes of administration), still widely debated, have varied with time and from one country to another (McNinch, 2010, para. 1).  The search for the cause of HDN began in 1913 when Whipple 82 postulated that a lack of prothrombin activity could be a cause of HDN. In 1929, Henrik Dam 14 noticed that chicks fed a fat-free diet suffered subcutaneous and intramuscular haemorrhages, which could be prevented if the chicks were fed seeds, cereals and green, leafy plants. Dam described the condition as a vitamin deficiency and named the deficient vitamin 'vitamin K', from the Danish word 'koagulation'.

26 History Of Vitamin K Use To Prevent Hemorrhagic Disease Of The Newborn.  Research in 1937 found that prothrombin times in normal neonates were between 30-60% adult levels, falling to 15-30% on day two, and then gradually rising again until about day 10. This research led to the continuing belief that these low levels in the newborn are a deficiency and need to be corrected.  In 1939, vitamin K 1 was isolated from alfalfa by Dam, for which he later received the Nobel Prize, along with Edward Doisy, who isolated vitamin K 2.  Further research in 1939 by Waddell and Guerry found that low plasma prothrombin levels could be elevated by the administration of oral vitamin K.  Armed with this 'proof' that vitamin K deficiency caused HDN, vitamin K was synthesised and various trials were commenced to ascertain which was the most effective amount and route to use in prophylaxis.

27 History Of Vitamin K Use To Prevent Hemorrhagic Disease Of The Newborn.  In 1961, the Committee on Nutrition of the American Academy of Pediatrics (AAP) recommended that vitamin K 1 (hereafter referred to as vitamin K, the only form of vitamin K 1 used in neonates) 0.5 to 1.0 mg be administered intramuscularly to all newborns shortly after birth to prevent Hemorrhagic disease of the newborn (HDNB  In 1988, the Canadian Pediatric Society (CPS) indicated that 2.0 mg of vitamin K administered orally within 6 h of birth was an acceptable alternative. Although other countries joined Canada in recommending the alternative oral administration of vitamin K, the AAP has continued to advocate sole use of the intramuscular route, noting that an approved oral form is not available. ( Canadian Paediatric Society, 2013, para.1 ) (( (9(((

28 Vitamin K deficiency bleeding; VKDB ( Hemorrhagic disease of the newborn)  Vitamin K deficiency bleeding (VKDB) is a bleeding problem that occurs in a newborn during the first few days of life. VKDB was previously called hemorrhagic disease of the newborn (Lucille Packard Childrens Hospital At Stanford, 2013, para. 1). It presents as unexpected bleeding, often with gastrointestinal hemorrhage and ecchymosis, and, in many cases, intracranial hemorrhage.  Levels of the active forms of vitamin-K dependent procoagulant factors (factors II, VII, IX, and X), and of the natural anticouagulants protein c and protein S, are physiologically low at birth. Vitamin K is essential for for Y-carboxylation of these proteins, which converts them to their active form (Roberts & Murray, 2012, p. 775)

29 Vitamin K deficiency bleeding; VKDB (Hemorrhagic disease of the newborn)  Newborn infants are at risk of developing vitamin K deficiency, and this coagulation abnormality leads to serious bleeding. Transplacental transfer of vitamin K is very limited during pregnancy, and the storage of vitamin K in neonatal liver is also limited. This makes the newborn infant uniquely vulnerable to hemorrhagic disorders unless exogenous vitamin K is given for prevention of bleeding immediately after birth.  The most common sites of hemorrhage or bleeding are the umbilicus, mucus membrane, the GI tract, circumcision, and venipuncture sites. Hematomas frequently occur at the sites of trauma (ie, large cephalohematomas, scalp bruising related to instrumentation used at delivery, and, rarely, intracranial hemorrhage). Neonatal mortality and long- term neurologic morbidity are severe consequences of vitamin K deficiency bleeding (Nimavat, 2012, p. 2)

30 Vitamin K deficiency bleeding; VKDB (Hemorrhagic disease of the newborn)  Placental transfer of vitamin K is very limited, [13] and phylloquinone (vitamin K 1 ) levels in umbilical cord blood is very low. [14] The newborn infant’s intestinal tract is relatively sterile and takes some time to colonize with bacteria, which may have a role in synthesizing vitamin K 2 (menaquinones).  Breast milk is a poor source of vitamin K (breast milk levels are 1-4 μ g/L). The recommended dietary intake of vitamin K is 1 μ g/kg/d. [16] Exclusively breastfed infants have intestinal colonization with lactobacilli that do not synthesize vitamin K; thus, reduced production of menaquinones increases the neonatal risk of developing a hemorrhagic disorder if not supplemented with vitamin K. Formula-fed infants have higher fecal concentrations of vitamin K 1 because of dietary intake and significant quantities of fecal menaquinones, reflecting the gut’s microflora. (Nimavat, 2012, p. 2).

31 Vitamin K deficiency bleeding; VKDB (Hemorrhagic disease of the newborn) VKDB can be classified into :  Early VKDB :This presents in the first 24 hours of life, usually with severe haemorrhage, including GI bleeding, and intracranial hemorrhage. It is caused by severe vitamin K deficiency in utero, usually result of maternal medication that interferes with vitamin K ( ex. Anticonvulsants)  Classical VKDB :This presents at 2-7 days old in babies who have not received prophylactic vitamin k at birth. The risk is increased in breastfeed babies in those with poor oral intake.  Late VKDB : This occurs in the first week of life,most often between 2 and 8 weeks after birth. The characteristic presentation is of sudden intracranial hemorrhage in an otherwise well, breastfed term infant or in babies with liver disease or malabsorptive states.

32 Vitamin K Prophylaxis In The Newborn  Prevention of vitamin K deficiency bleeding (VKDB) with intramuscular vitamin K is of primary importance in the medical care of neonates. A single dose of intramuscular vitamin K after birth effectively prevents classic vitamin K deficiency bleeding. Conversely, oral vitamin K prophylaxis improves coagulation test results at 1-7 days, but vitamin K administered by this route has not been tested in randomized trials for its efficacy in preventing either classic or late vitamin K deficiency bleeding. [18, 19]  The American Academy of Pediatrics in their policy statements has endorsed the universal supplementation of vitamin K using the intramuscular injection (IM) because no vitamin K preparation is licensed for oral use in the United States.

33 Vitamin K Prophylaxis In The Newborn Vitamin K Action : Vitamin K is required for synthesis of prothrombin and three other clotting factors : VII, IX, and X. All of these vitamin k –dependent factors are needed for coagulation of blood. Forms and Sources of Vitamin K : Vitamin K occurs in nature in two forms: (1) vitamin K1, or phytonadione ( phyloquinone) and (2) vitamin k2. Vitamin k2 is present in wide variety of foods. Vitamin K2 is synthesized by the normal flora of the gut. Two other forms – vitamin k4 ( menadiol) and vitamin k3 (menadione)- are produced synthetically. At this time, phytonadione is the only form of vitamin k available for therapeutic use. (Lehne, 2013, p. 1031-1032)

34 Vitamin K Prophylaxis In The Newborn Therapeutic Use and Dosage Vitamin K Deficiency : Vitamin K deficiency produces bleeding tendencies. If the deficiency is severe, spontaneous hemorrhage may occur. In newborns, intracranial hemorrhage is of particular concern. The normal infant is born vitamin k deficient. Consequently, in order to rapidly elevate prothrombin levels, and thereby reduce the risk of neonatal hemorrhage, it is recommended that all infants receive a single injection of phytonadione ( vitamin K1 ), 0.5mg to 1mg, immediately after (Lehne, 2013, p. 1031-1032).

35 Pertinent Research Theories And Evidence Based Practice  Two eligible randomized trials, each comparing a single dose of intramuscular vitamin K with placebo or nothing, assessed effect on clinical bleeding. One dose of vitamin K reduced clinical bleeding at 1 ‐ 7 days, including bleeding after circumcision, and improved biochemical indices of coagulation status. Eleven additional eligible randomized trials compared either a single oral dose of vitamin K with placebo or nothing, a single oral with a single intramuscular dose of vitamin K, or three oral doses with a single intramuscular dose. None of these trials assessed clinical bleeding. Oral vitamin K improved biochemical indices of coagulation status at 1 ‐ 7 days. There was no evidence of a difference between the oral and intramuscular route in effects on biochemical indices of coagulation status. A single oral compared with a single intramuscular dose resulted in lower plasma vitamin K levels at two weeks and one month, whereas a 3 ‐ dose oral schedule resulted in higher plasma vitamin K levels at two weeks and at two months than did a single intramuscular dose (Puckett & Offringa, 2009, p. 1).

36 Pertinent Research Theories And Evidence Based Practice  By 1950, most maternity units had a policy of giving infants oral vitamin K (usually Synkavite) immediately after birth. This prevented the fall in prothrombin levels that occurred in the first few days and, presumably, the risk of excessive bleeding. This risk was higher in male babies because of routine circumcision, and, indeed, vitamin K proved to be of great clinical value in preventing post-circumcision bleeding.  Then, in the mid-1950's, reports of increased jaundice and kernicterus (brain damage caused by high bilirubin levels) associated with vitamin K prophylaxis began circulating. Reviews of maternity units found that some were giving Synkavite in doses exceeding 50mg. 70 It was established that high doses of Synkavite caused haemolysis (destruction of red blood cells) and high serum bilirubin levels.

37 Pertinent Research Theories And Evidence Based Practice  Researchers and medical professionals queried the safety aspects of vitamin K, and there were many conflicting reports on the appropriate dosages. Some researchers queried the need for vitamin K at all, quoting results from studies that showed no difference in prothrombin times or vitamin K plasma levels between babies that bled and babies that didn't.  Eventually, a newer preparation, intramuscular vitamin K1 (phytomenadione), was developed and approved for use, solely on the grounds that it appeared to cause less haemolysis. Phytomenadione (trade names Konakion (Roche) or Aquamephyton (Merck, Sharpe & Dohme) is a synthetic petrochemical derived from 2-methyl 1,4-naptha- quinone in a polyethoxylated castor oil base. In the US, polysorbate-80 is used as a base instead of polyethoxylated castor oil.

38 Pertinent Research Theories And Evidence Based Practice  There has been controversy regarding whether childhood cancer is associated with IM administration of vitamin K to newborn infants.  A study was conducted in all maternity hospitals in Sweden on infants born after a normal delivery during 1973-1989 that received vitamin K. Occurrence of cancer up to the end of 1991 was identified by comparing these records with the national cancer registry.  Of the 1,384,424 full term infants, 1,085,654 received vitamin K IM and 272, 080 received it orally. The risk of cancer after IM administration of vitamin K was not elevated compared with that after oral administration: odds ratios of 1.01 for all childhood cancers and 0.90 for childhood leukemia. The association of IM vitamin K prophylaxis to newborn infants and childhood cancer could not be verified in the present study (Ekelund, Finnstrom, Gunnarskog, Kallen, and Larsson, 1993).

39 Pertinent Research Theories And Evidence Based Practice Because parenteral vitamin K has been shown to prevent late onset VKBD of the newborn and young infant and the risks of cancer have been unproven, the American Academy of Pediatrics recommends the following:  Vitamin K should be given IM to all newborns  Additional research needs to be conducted on the efficacy, safety, and bioavailability of oral formulations and dosing regimens of vitamin K to prevent late VKBD  Health care professionals should promote awareness among families of the risks of late VKBD associated with inadequate vitamin K prophylaxis from current oral dosage regimens, particularly for newborns who are breastfed exclusively.

40 Vitamin K Deficiency Bleeding Outcome  A single 1 mg dose of vitamin K 1 (phytonadione: a liposoluble vitamin K analog) (hereafter referred to as vitamin K) at birth prevents almost all cases of classic and late HDNB.  Increased incidence of late HDNB occurred when vitamin K prophylaxis was absent or given orally, especially if the infant had been exclusively breast-fed or had cholestasis.  Intracranial hemorrhage is responsible for nearly all mortality and long- term sequelae due to vitamin K deficiency bleeding.  Late HDNB occurs in five to seven of 100,000 live births without vitamin K prophylaxis and results in death or severe disability in 33% of affected newborns. (Paediatrics and child health, 2002, p. 1)

41 References American Academy of Pediatrics (2003). Controversies Concerning Vitamin K and the Newborn. Official Journal of the American Academy of Pediatrics, 112(1), 191-192. Retrieved from http://pediatrics.aapublications.org.libux.utmb.edu/content/112/1/191.full Bausch & Lomb Incorporated. (2008). ERYTHROMYCIN - erythromycin ointment. Retrieved 10/18/2013, from http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=9427 Canadian Paediatric Society. (2013). Routine administration of vitamin K to newborns. Retrieved 10/13/2013, from http://www.cps.ca/en/documents/position/administration-vitamin-K-newborns Darling, E., & McDonald, H. (2010). A meta-analysis of the efficacy of ocular prophylactic agents used for the prevention of gonococcal and chlamydial ophthalmia neonatorum. Retrieved 10/15/2013, from http://www.ncbi.nlm.nih.gov/pubmed/20630358 Dekker, R. (2012). Is erythromycin eye ointment always necessary for newborns ? Retrieved 10/16/02013, from http://evidencebasedbirth.com/is-erythromycin-eye-ointment-always-necessary- for-newborns/http://evidencebasedbirth.com/is-erythromycin-eye-ointment-always-necessary- for-newborns/ Ekelund, H., Finnstrom, O., Gunnarskog, J., Kallen, B., & Larsson, Y. (1993). Administration of vitamin K to newborns and childhood cancer. British Medical Journal, 307(6896), 89-91. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1693492/#reference-sechttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC1693492/#reference-sec

42 References McNinch, A. (2010). Vitamin K deficiency bleeding: early history and recent trends in the United Kingdom. Retrieved 10/19/2013, from http://www.ncbi.nlm.nih.gov/pubmed/20167443 Lehne, R. (2013). Pharmacology for nursing care (8th ed.). St. Louis Missouri: Elsevier Saunders. Lucille packard childrens hospital at stanford. (2013). Vitamin K Deficiency Bleeding (Hemorrhagic Disease of the Newborn) Retrieved 10/19/2013, from http://www.lpch.org/DiseaseHealthInfo/HealthLibrary/hrnewborn/hrdn.html http://www.lpch.org/DiseaseHealthInfo/HealthLibrary/hrnewborn/hrdn.html Moseley, J. (2003). Ophthalmia neonatorum. Wormald, R. Henshaw, K. Smeeth, & Liam (Eds.), Evidenced-based ophthalmology (pp. 71-79). Retrieved from http://ar.utmb.edu/ar/library/tabid/155/default.aspx Nimavat, D. (2012). Hemorrhagic disease of the newborn. Retrieved 10/19/2013, from http://emedicine.medscape.com/article/974489-overview#a0104 Paediatrics and child health. (2002). Vitamin K injection – best prevention for newborns. Retrieved 10/19/2013, from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2798607/ Puckett, R., & Offringa, M. (2009). Prophylactic vitamin K for vitamin K deficiency bleeding in neonates - See more at: http://summaries.cochrane.org/CD002776/prophylactic-vitamin-k-for- vitamin-k-deficiency-bleeding-in-neonates#sthash.elSDBNZc.dpuf. Retrieved 10/19/2013, from http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD002776/abstract

43 References Roberts, I., & Murray, N. (2012). Haematology. In J. Rennie (Ed.), Rennie & Roberton’s textbook of neonatology (5th ed., pp. 755-790). London, UK: ChurchChill Livingstone Elsevier. Rothville, K. (“n.d”). Vitamin K: controversy? what controversy? Retrieved 10/19/2013, from http://www.vaclib.org/basic/vitamin-k.htm The journal of the american medical association. ( 1980). Three infant care interventions: reconsidering the evidence. Retrieved 10/16/2013, from http://jama.jamanetwork.com/article.aspx?articleid=372547 U.S. Preventive Services Task Force. (2009). Ocular prophylaxis for gonococcal ophthalmia neonatorum. Retrieved 10/16/2013, from http://www.uspreventiveservicestaskforce.org/uspstf10/gonoculproph/gonocupap1.htm

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