Featured Cases: IV Soybean Oil-Based And Parenteral Omega-3 Lipid Emulsions In The PNALD Setting

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1 HOME CME/CE INFORMATION PROGRAM DIRECTORS NEWSLETTER ARCHIVE EDIT PROFILE RECOMMEND TO A COLLEAGUE volume 9 issue 16: TRANScRipT Featured Cases: IV Soybean Oil-Based And Parenteral Omega-3 Lipid Emulsions In The PNALD Setting Our guest author is Darla Shores, Assistant Professor of Pediatric Gastroenterology & Nutrition at the Johns Hopkins Children s Center in. MEET ThE AUThoR Darla Shores, MD Assistant Professor, Pediatric Gastroenterology & Nutrition Johns Hopkins Children's Center After participating in this activity, the participant will demonstrate the ability to: n Describe the key differences in fatty acid composition between soy and fish oil emulsions. n Discuss the indications for compassionate use of fish oil emulsions. n Summarize the safety concerns associated with fish oil emulsions. This discussion, offered as a downloadable audio file and companion transcript, covers the important issues related to IV soybean oil-based and parenteral omega3 lipid emulsions in the format of case-study scenarios for the clinical practice. This program is a follow up to the Volume 9, Issue 15 eneonatal Review newsletter IV Soybean Oil-Based and Parenteral Omega-3 Lipid Emulsions in the PNALD Setting. Guest Faculty Disclosure The author has indicated that she has no financial interests or relationships with a commercial entity whose products or services are relevant to the content of her presentation. Unlabeled/Unapproved Uses The author has indicated that her discussion will reference the unlabeled or unapproved uses of fish oil emulsion compounds. Release Date December 19, 2013 Expiration Date December 18, 2015 program DiREcToRS Edward E. Lawson, MD Professor of Pediatrics Johns Hopkins University School of Medicine Chief, Division of Neonatology Vice Chair, Department of Pediatrics Johns Hopkins Children s Center Maureen M. Gilmore, MD Assistant Professor of Pediatrics Director of Neonatology Johns Hopkins Bayview Medical Center Lawrence M. Nogee, MD Professor Department of Pediatrics Division of Neonatology The Johns Hopkins University School of Medicine Mary Terhaar, DNSc, RN Assistant Professor Undergraduate Instruction The Johns Hopkins University School of Nursing Anthony Bilenki, MA, RRT Technical Director Respiratory Care Services Division of Anesthesiology and Critical Care Medicine The Johns Hopkins Hospital

2 cme/ce information _ program BEGiNS BELow AccREDiTATioN STATEMENTS physicians This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the Johns Hopkins University School of Medicine and The Institute for Johns Hopkins Nursing. The Johns Hopkins University School of Medicine is accredited by the ACCME to provide continuing medical education for physicians. Nurses The Institute for Johns Hopkins Nursing is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. 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SUccESSFUL completion To successfully complete this activity, participants must read the content, and then link to the Johns Hopkins University School of Medicine's CME website, or the Institute for Johns Hopkins Nursing to complete the post test and evaluation. Once you receive a passing grade, you can access and print your certificate of credit. NOTE: If you have already registered for other Hopkins CME programs on their prospective websites simply enter the requested information when prompted. There are no fees or prerequisites for this activity. This activity is supported by educational grants from Abbott Nutrition, Cornerstone Pharmaceuticals, Ikaria, and Mead Johnson Nutrition. LAUNch DATE June 21, 2012; activities expire two years from the date of each publication. internet cme policy The Office of Continuing Medical Education (OCME) at the Johns Hopkins University School of Medicine is committed to protecting the privacy of its members and customers. Johns Hopkins University SOM CME maintains its Internet site as an information resource and service for physicians, other health professionals and the public. Continuing Medical Education at the Johns Hopkins University School of Medicine will keep your personal and credit information confidential when you participate in a CME Internet based program. Your information will never be given to anyone outside of the Johns Hopkins University School of Medicine's CME program. CME collects only the information necessary to provide you with the services that you request. DiScLAiMER STATEMENT The opinions and recommendations expressed by faculty and other experts whose input is included in this program are their own. This enduring material is produced for educational purposes only. Use of the Johns Hopkins University School of Medicine name implies a review of educational format, design, and approach. Please review the complete prescribing information of specific drugs or combination of drugs, including indications, contraindications, warnings, and adverse effects, before administering pharmacologic therapy to patients. STATEMENT of RESpoNSiBiLiTy The Johns Hopkins University School of Medicine takes responsibility for the content, quality, and scientific integrity of this CME activity. STATEMENT of NEED Through discussions with expert physician/educators, a survey of practicing neonatologists, and a review of the current literature, including national and regional guidelines and quality-ofcare measures, the following core learning gaps have been identified: n In addition to cognitive, educational, and behavioral impairments later in life, former premature infants with BPD also suffer higher rates of long-term airway obstruction and mild exercise intolerance, potentially preventable with better NICU and post-discharge care. n Protocols for noninvasive methods of pulmonary support are underused or misused in many neonatal care settings, resulting in higher rates of lung injury in preterm infants from mechanical ventilation. n Neonatologists need a consistent and precise approach to the diagnosis and treatment of ventilator-acquired pneumonia (VAP) to minimize ineffective empiric antibiotic treatment. n Although major reductions in the burden of CLABSI in NICUs have been achieved, variable rates of sepsis in different NICUs indicate that adherence to best practices and vigilant preventive interventions are not as uniform as they could and should be. n Too few of the 90% of premature infants discharged with nutritional deficiencies receive calorie- and protein-enriched formulas that prevent near-term developmental deficits and long-term damaging health effects, such as metabolic syndrome. n Neonatologists are not fully aware of the comparative merits of IV soybean oil-based lipid emulsions and parenteral omega-3 lipid emulsions in the PNALD setting. intended AUDiENcE This activity has been developed for neonatologists, respiratory therapists, neonatal nurses and nurse practitioners, and others involved in the care of patients in the NICU. 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3 eneonatal REviEw podcast TRANScRipT MR. BoB BUSKER: Welcome to this eneonatal Review Podcast. eneonatal Review is presented by the Johns Hopkins University School of Medicine, and the Institute for Johns Hopkins Nursing. This program is supported by educational grants from Abbott Nutrition, Cornerstone Pharmaceuticals, Ikaria, and Mead Johnson Nutrition. Today s program is a companion piece to our eneonatal Review newsletter issue: IV Soybean Oil- Based and Parenteral Omega-3 Lipid Emulsions in the PNALD Setting. Our guest today is one of that issue s authors, Dr. Darla Shores, from the Johns Hopkins Children s Center. This activity has been developed for neonatologists, respiratory therapists, nurse practitioners, neonatal nurses, and others who work in the NICU. There are no fees or prerequisites for this activity. The Accreditation and Credit Designation Statements can be found at the end of this podcast. For additional information about accreditation, Hopkins policies, and expiration dates and to take the posttest to receive credit online, please go to our website newsletter archive, and click the Volume 9, Issue 16 podcast link. Learning objectives for this audio program are, that after completing this activity, the participant will demonstrate the ability to: n Describe the key differences in fatty acid composition between soy and fish oil emulsions. n Discuss the indications for compassionate use of fish oil emulsions. n Summarize the safety concerns associated with fish oil emulsions. I m Bob Busker, managing editor of eneonatal Review. On the line we have with us Dr. Darla Shores, Assistant Professor of Pediatric Gastroenterology & Nutrition at the Johns Hopkins Children s Center in. Dr. Shores has indicated that she has no financial interests or relationships with any commercial entity whose products or services are relevant to the content of this presentation. Her discussion today will reference the unlabeled or unapproved uses of fish oil emulsion compounds. Dr. Shores welcome to this eneonatal Review podcast. DR. ShoRES: Thank you very much for having me. MR. BUSKER: In your newsletter issue, Doctor, you reviewed investigations into fish oil emulsions as treatment for parenteral nutrition-associated liver disease or PNALD in neonates. Today I d like to place some of that information into a clinical context. So let me ask you to start things off by describing a patient for us, if you would, please. DR. ShoRES: Our first case is a male born at 38-4/7 weeks weighing 3.4 kg via spontaneous vaginal delivery. There were no complications during the pregnancy or the delivery. The baby is breastfed but vomits after each feeding. Upper GI contrast imaging shows a single area of narrowing in the jejunum. Surgery is consulted and plans are made for surgical resection of the intestinal atresia. You start parenteral nutrition with a soy emulsion and you expect to continue this for two to three weeks. MR. BUSKER: What s important for clinicians to know about soy emulsions? DR. ShoRES: Soy is a standard lipid most commonly found in parenteral nutrition, or PN, in the US, and it is the only FDA- approved lipid that we have. Soy is a mixture of different fatty acids, but it s predominantly linoleic acid. Linoleic acid is an essential fatty acid. It s a long chain omega-6 fatty acid, and it must come from the diet as the body is unable to synthesize this fatty acid from other precursors. Linoleic acid is important in cellular signaling, growth, and development. It is typically dosed between 3 gm/kg and 4 gm/kg to provide sufficient calories for growth, but unfortunately, soy has been linked to parenteral nutrition-associated liver disease or PNALD for short, which is essentially defined as cholestasis or having a direct bilirubin of at least 2 mg/dl. 1

4 MR. BUSKER: Do we know how soy emulsion is related to PNALD? DR. ShoRES: PNALD truly is a complicated, multifactorial process, but soy is directly related in two ways. First of all, the phytosterols found in soy can be directly toxic to hepatocytes, especially in the immature liver of a new baby, and secondly, the major lipid component, linoleic acid, is metabolized along the arachidonic pathway into proinflammatory eicosanoids, such as leukotrienes, thromboxane, and other prostaglandins. These eicosanoids are necessary for a normally functioning immune system, but overproduction can contribute to systemic inflammatory states, and any type of systemic inflammation can exacerbate cholestasis by impeding bile flow. We particularly see this in cases of bacteremia or line sepsis where there is often a dramatic rise in bilirubin following these episodes. And of course, we can t forget about the role of the gut. The intestinal cells need direct contact with nutrients in order to thrive and adapt and maintain their barrier function which helps keep out antigens and bacteria. And finally, other risk factors associated with PNALD include being premature, losing the ileocecal valves, or having necrotizing enterocolitis. MR. BUSKER: You ve described some potential problems with soy emulsions. What other options are available? DR. ShoRES: Across Europe, alternate forms of lipids are widely used and these lipids are derived from fish oil, which seems to show the most promise in reversing PNALD. The main difference between fish and soy emulsions is that fish oil is predominantly made of long chain omega-3 fatty acids, which are also metabolized into prostaglandins, but they have beneficial antiinflammatory properties. These mechanisms are nicely outlined in the Seida article in the newsletter. 1 There are several preparations of these fish emulsions which may be entirely derived from fish oil, or they contain fish oil in combination with other fatty acids such as soy, olive, or medium- chain triglycerides. In the US, these are only available for compassionate use; they are not FDA-approved, so an investigational new drug, or IND protocol, is necessary for their use. MR. BUSKER: Would fish oil emulsions be likely to prevent PNALD in this patient, Dr. Shores? What have the data shown? DR. ShoRES: Well fish oil has been to reverse PNALD, but we don t know if it actually prevents PNALD from occurring in the first place. And it may not be necessary for all infants. So far there s been one randomized control trial which is the Nehra article in the newsletter, which compares fish oil to soy oil before cholestasis begins in neonates who ve had bowel resection. 2 It had to be terminated early as the incidence of PNALD was surprisingly low in both arms of the study. Importantly, these infants were relatively healthy and were not premature. Also keep in mind that this study was carried out in a center that pays close attention to enteral nutrition management and infection control, which highlights how important these other factors are in preventing PNALD. They do plan to repeat this study with higher risk patients. MR. BUSKER: Thank you for that case and that discussion, Doctor. Let me ask you to bring us another patient now if you would, please. DR. ShoRES: Our next case is a female born at 26-2/7 weeks weighing 820 gm via vaginal delivery for spontaneous rupture of membranes in the setting of maternal fever. On day of life six, trophic feeds of breast milk were given via nasogastric tube and advanced slowly. After one week the abdomen became distended, and blood was seen in the stool. Abdominal films confirmed pneumatosis with suspected free air. The infant was emergently taken to the operating room where 20 centimeters of necrotic ileum were resected. Blood culture was positive for E. coli. After two weeks of bowel rest and IV antibiotics, the infant is more stable, but the serum total bilirubin has now risen to 6.8 mg/dl, with a direct bilirubin of 4.1 mg/dl. MR. BUSKER: What s the significance of the direct bilirubin? DR. ShoRES: The direct bilirubin in this case is worrisome. This patient has many more risk factors for developing severe PNALD. This patient is premature, has sepsis with positive cultures, 2

5 has necrotizing enterocolitis, and had a sizable bowel resection which may or may not have included the ileocecal valve. This patient is likely going to have a prolonged course of parenteral nutrition and may or may not tolerate much in the way of enteral nutrition. This is a patient that I would be worried about developing not only severe cholestasis but may eventually develop chronic liver disease. This is especially true if this patient remains on parenteral nutrition and we are unable to reverse the cholestasis. MR. BUSKER: In the event that the cholestasis cannot be reversed what could be done to treat it? DR. ShoRES: There are several strategies to treat cholestasis. One of the most important is trying to advance enteral feedings as quickly as possible. This helps both improve gut function and also lessens the exposure to the lipids and other components of parenteral nutrition. Unfortunately, it s not always easy to advance feedings in every infant, particularly if there is a significant amount of gut dysmotility. We ve also mentioned that sepsis prevention is very important in not exacerbating cholestasis, so line care is going to be particularly important in these infants. There have also been some limited successes in using other medications such as ursodiol, which help promote bile conjugation and excretion. Something many of us do in practice is to lower the dose of the soy lipids down to 1 gm/kg per day and, of course, finally, the other option is the use of fish oil emulsions. MR. BUSKER: What does the data show about using fish oil emulsions for cholestasis? DR. ShoRES: So far there is limited data, mostly from small observational studies, and these are highlighted in the Seida and Premkumar articles mentioned in the newsletter. 1,3 It does seem, however, that fish oil emulsions are more effective at reversing cholestasis, meaning that there is truly a faster normalization of bilirubin and the transaminases, compared to infants who ve been treated with soy emulsions at lower doses. In our patient scenario, who is more likely to be at risk for chronic liver disease, this would be an appropriate candidate for using fish oil emulsion. Remember, however, that if you do want to use fish oil, you need to have permission from your institutional IRB and to obtain an IND protocol from the FDA. MR. BUSKER: How and when should fish oil be administered to a neonate? DR. ShoRES: The optimal time to begin fish oil is not yet known. We presume that starting fish oil earlier in the process of cholestasis would be more effective than waiting several weeks or several months before starting the fish oil, especially when we re considering not just reversing the elevated chemical cholestasis and looking at a reduction in the bilirubin, but also reversing actual liver damage. Many of the studies reviewed in this session begin with using fish oil once the direct bilirubin has reached 2 mg/dl to 4 mg/dl and this is depending on other PNALD risk factors such as an infant who has prematurity and a bowel resection, they may start at a lower bilirubin level of 2 mg/dl; whereas in an infant who has less risk factors, they may wait until the bilirubin reaches 4 mg/dl. We don t yet have studies that suggest we need to start using fish oil prior to the onset of cholestasis, but this is certainly an area in need of investigation, particularly when we re looking at infants who are going to have a high risk of developing cholestasis. When fish oil emulsions are used, they are generally dosed at 1 gm/kg/day, which is lower than what traditional soy emulsions were started with. They are typically continued for the duration of parenteral nutrition use, however, some centers are starting to use it for a finite periods of time such as six months and then transitioning back to soy emulsion. We don t yet know what the optimal length of time that infants should stay on fish oil emulsion when we do decide to use it. MR. BUSKER: Let s return to the patient you described. How was this baby treated and what were the outcomes? DR. ShoRES: This baby was at a facility where an investigational new drug protocol for the use of fish oil was available, so this infant did receive a lower dose of fish oil at 1 gm/kg/day and the soy emulsion was discontinued. This baby, unfortunately, had a lot of difficulty in being able to advance to enteral 3

6 nutrition, so despite the fact that the liver numbers continued to improve and the bilirubin did come down, this baby did eventually develop cirrhosis and needed to be referred to a center for transplant evaluation of both the intestine and the liver. I think this case highlights how important it is to try to treat cholestasis early when it does occur and to keep in mind that even though we do have some options for treating this cholestasis, it can eventually result in end stage liver failure, which is a very serious complication. MR. BUSKER: Thank you, doctor. And we ll return with Dr. Darla Shores from the Johns Hopkins Children s Center. DR. MAUREEN GiLMoRE: Hello. I m Maureen Gilmore, assistant professor of pediatrics and director of neonatology at Johns Hopkins Bayview Medical Center. I m one of the program directors of eneonatal Review. eneonatal Review is a combination newsletter and podcast program delivered via to subscribers. Newsletters are published every other month. Each issue reviews the current literature in areas of importance to neonatologists, respiratory therapists, neonatal nurses and nurse practitioners, and other health care practitioners whose work/practice includes treating neonates. Bimonthly podcasts are also available as downloadable transcripts, providing case-based scenarios to help bring that new clinical information into practice in the delivery room and at the bedside. Join over 10,000 of your colleagues and subscribe to eneonatal Review. Subscription to eneonatal Review is provided without charge or prerequisite. Continuing education credit for each issue and each podcast is provided by the Johns Hopkins University School of Medicine and the Institute for John Hopkins Nursing. For more information on this educational activity, to subscribe and receive eneonatal Review without charge, and access back-issues, please go to our website: Thank you. MR. BUSKER: Welcome back to this eneonatal Review podcast. I m Bob Busker, managing editor of the program. Our guest is Dr. Darla Shores, Assistant Professor of Pediatric Gastroenterology & Nutrition at the Johns Hopkins Children s Center in Baltimore. And our topic is IV Soybean Oil-Based and Parenteral Omega-3 Lipid Emulsions in the PNALD Setting. We ve been looking at how some of the new information Dr. Shores discussed in her newsletter issue can be applied in the NICU. So if you would, Doctor, please describe another patient for us. DR. ShoRES: Our final case is a male born at 31-1/7 weeks weighing 1,500 gm who developed a volvulus shortly after birth and required surgical resection of 45 cm of small bowel, which did include the ileocecal valve. Three weeks after resection his direct bilirubin has risen to 5.6 mg/dl, and he was started on a fish oil emulsion at 1 gm/kg/day. Six weeks later, his direct bilirubin is down to 1.3 mg/dl, but he continues to need parenteral nutrition due to poor enteral absorption. MR. BUSKER: As you described, this is an infant who may be on fish oil emulsion for quite some time. What s known about the potential risks of fish oil emulsion? DR. ShoRES: There are several potential risks involved with using fish oil and we do have limited studies to really explore how safe these emulsions are to use over the long-term. In some of the adult studies where fish oil was used, there was concern that there may be increased bleeding tendency. So far this has not really been a complication that s been seen in using fish oil in neonates. Our major concern is really growth and nutrition, particularly whether or not there is a risk for essential fatty acid deficiency, since the lipid dose that we use is relatively low, only 1 gram/kg/day. And as we mentioned before, fish oil does not contain linoleic acid, which is one of the essential fatty acids. Interestingly, in the studies that we have reviewed in this newsletter, when dosed appropriately there has not been any evidence of essential fatty acid deficiency, and this is measured by looking at the triene-to-tetraene ratios. It turns out that the infants 4

7 are able to utilize fish oil to make appropriate fatty acids needed for normal cellular function. As I mentioned earlier, fish oil mostly contains long chain fatty acids. It s also unclear whether there might be potential deficiencies that occur after prolonged use, say for months or even years, of some of the other dietary lipids such as short chain fatty acids or medium chain triglycerides, especially if the infant is not able to receive some of these other forms of lipids through the gut. MR. BUSKER: Talk to us some more, if you would, about changes seen in the serum fatty acids. DR. ShoRES: So far the serum changes in fatty acids in lipid profiles appear to be beneficial and are nicely outlined in the Le article, which is reviewed in the newsletter. 4 As expected, the level of antiinflammatory omega-3 fatty acids which are predominantly eicosapentaenoic acid, otherwise known as EPA, and docosahexaenoic acid, also known as DHA, go up with the use of fish oil. As expected, we also see a decrease in the proinflammatory omega-6 fatty acids, which were derived from linoleic acid and arachidonic acid. Also outlined in this study is that there continues to be an appropriate triene-to-tetraene ratio, meaning that there is no sign of essential fatty acid deficiency, and the lipid profile, itself, seems to be beneficial. There is a decrease in the so-called bad cholesterol component such as LDL and VLDL and serum triglycerides with an upward trend in the good cholesterol which is the HDL measurement. MR. BUSKER: What about the effects on growth and development? DR. ShoRES: This is another major concern about the prolonged exposure to lower lipid dosing and whether or not growth will be significantly impacted. In the observational studies done here in the US, there has so far been no difference in weight of these scores when using fish oil dosed at 1 gm/kg/day, or soy oil dosed at 1 gm/kg/day when it s compared to the traditional higher dosing of soy at 3 to 4 gm/kg/day. So far growth seems to be on par with the traditional higher dosing. We do have to keep in mind that these studies compare average weight between groups so there certainly may be some individual differences that might occur. We should also keep in mind that many of these infants are receiving at least some enteral nutrition which is going to be providing calories and fat, so there might be more of a difference in growth among patients who cannot tolerate enteral nutrition who remain on low lipid doses, whether it s from either fish or soy oil. Fatty acids are not just important for growth, but they are also necessary for central nervous system development, and in this case fish oil may actually be more beneficial for early brain development compared to other lipids such as soy. So far among the limited studies, neurodevelopment has been equivalent among those infants who are treated with fish oil, although long-term follow up for three years or greater has not been done at this point. MR. BUSKER: In the patient you described: six weeks after starting fish oil emulsions, his bilirubin went down from 5.6 to 1.3, which would seem to show that his cholestasis has been resolved. Does that mean his liver has actually healed? DR. ShoRES: This is a very good question. We don t routinely obtain liver biopsies once cholestasis has resolved in these patients to ensure that all evidence of liver damage, such as inflammation or fibrosis, have truly resolved. In the few research protocols where biopsies are obtained, liver inflammation typically improves as we see the bilirubin numbers go down and the cholestasis resolves. Unfortunately, liver fibrosis does not always go away, even if the serum liver tests have completely returned to normal. There have been several reports of progressive liver injury that eventually leads to cirrhosis and liver failure, despite the use of fish oil emulsion and with initial normalization of lab values. So far there have just not been many studies that measure long-term outcomes. While we know that fish oil definitely improves biochemical evidence of cholestasis in the short-term, we don t know what the impact is going to be on the long-term issues such as chronic liver disease, need for liver transplantation, or even mortality. We also don t know how to monitor for slowly progressive liver disease once lab values have normalized, and this continues to be a need for research. 5

8 MR. BUSKER: Thank you for those cases and your discussion today, Dr. Shores. Talk to us now, if you would, about what questions still remain about the use of fish oil emulsions. DR. ShoRES: The use of fish oil is exciting for infants who have cholestasis, and the science has been rapidly evolving in the last few years, but there are, of course, still many unanswered questions. The first question is, which population is most likely going to benefit from fish oil? We know that not all infants need to be placed on fish oil, but having a better understanding of which infants would benefit from not developing cholestasis in the first place is going to continue to be an important question. Number two is in regards to the timing, does it matter when we start fish oil in the setting of cholestasis in order to improve not just the short-term outcomes of reducing or preventing cholestasis, but also in reducing chronic liver damage and the need for transplantation? And finally, there are, of course, safety concerns as to what will happen after prolonged years of use. Whether this fish oil can be used just for a number of months or whether it can be safely used for years at a time, and whether we will start to see growth deficiencies or nutritional deficiencies that were not detected on the initial studies. As we ve mentioned, fish oil is only available for compassionate use; however, there are a number of studies that have protocols and are continuing to enroll patients and these questions are actively being investigated. MR. BUSKER: Thank you for sharing those thoughts, Doctor. To wrap things up, let s review what we ve discussed today in terms of our learning objectives. So to begin: the key differences in fatty acid composition between soy and fish oil emulsions. DR. ShoRES: Soy is predominantly made of omega-6 fatty acids, which have proinflammatory potential; and fish oil is predominantly made of omega-3 fatty acids with an antiinflammatory potential. MR. BUSKER: And: the indications for compassionate use of fish oil emulsions for neonates in the US? DR. ShoRES: Fish oil is not yet FDA-approved. Fish oil is promising for infants who have PNALD that has not resolved with other measures. Fish oil is also promising for infants with high risk factors predisposing them to PNALD such as prematurity or necrotizing enterocolitis. MR. BUSKER: And finally: the safety concerns associated with fish oil emulsions. DR. ShoRES: When dosed appropriately, essential fatty acid deficiency has not occurred with the use of fish oil. Adverse effects on growth and neurodevelopment have not been seen. Long-term safety studies have not yet been done. MR. BUSKER: Dr. Darla Shores, from the Johns Hopkins Children s Center, thank you for participating in this eneonatal Review Podcast. DR. ShoRES: It has been my pleasure. Thank you again for having me. MR. BUSKER: This podcast is presented in conjunction with the eneonatal Review Newsletter, a peer-reviewed literature review certified for CME/CE credit, ed monthly to clinicians treating patients in the NICU. This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education, through the joint sponsorship of the Johns Hopkins University School of Medicine and the Institute for Johns Hopkins Nursing. The Johns Hopkins University School of Medicine is accredited by the ACCME to provide continuing medical education for physicians. For physicians, the Johns Hopkins University School of Medicine designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in this activity. The Institute for Johns Hopkins Nursing is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center s Commission on Accreditation. The Institute for Johns Hopkins Nursing and the American Nurses Credentialing Center do not 6

9 endorse the use of any commercial products discussed or displayed in conjunction with this educational activity. For nurses, this 0.5 contact hour Educational Activity is provided by The Institute for Johns Hopkins Nursing. Each podcast carries a maximum of 0.5 contact hour. This educational resource is provided without charge, but registration is required. To register to receive eneonatal Review via , please go to our website, The opinions and recommendations expressed by faculty and other experts whose input is included in this program are their own. This enduring material is produced for educational purposes only. Use of names of the Johns Hopkins University School of Medicine and The Institute for Johns Hopkins Nursing implies review of educational format, design, and approach. Please review the complete prescribing information for specific drugs, combinations of drugs, or use of medical equipment, including indication, contraindications, warnings, and adverse effects, before administering therapy to patients. eneonatal Review is supported by educational grants from Abbott Nutrition, Cornerstone Pharmaceuticals, Ikaria, and Mead Johnson Nutrition. Thank you for listening. This program is copyright 2013, with all rights reserved, by the Johns Hopkins University School of Medicine and the Institute for Johns Hopkins Nursing. 7

10 REFERENcES 1. Seida JC, Mager DR, Harling L, Vandermeer B, Turner JM. Parenteral ω-3 fatty acid lipid emulsions for children with intestinal failure and other conditions: A systematic review. JPEN J Parenter Enteral Nutr. 2013;37: Nehra D, Fallon EM, Carlson SJ, P et al. Provision of a soy-based intravenous lipid emulsion at 1 g/kg/d does not prevent cholestasis in neonates. JPEN J Parenter Enteral Nutr. 2013;37(4): Premkumar MH, Carter BA, Hawthorne KM, King K, Abrams SA. High rates of resolution of cholestasis in parenteral nutrition-associated liver disease with fish oil-based lipid emulsion monotherapy. J Pediatr. 2013; 162: Le HD, de Meijer VE, Robinson EM, et al. Parenteral fish-oil-based lipid emulsion improves fatty acid profiles and lipids in parenteral nutrition-dependent children. Am J Clin Nutr. 2011;94:

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