Evaluating Provider Readiness to Adopt an Early Enteral Nutrition Guideline for Infants Undergoing Therapeutic Hypothermia: A Needs Assessment

The incidence of hypoxic-ischemic encephalopathy (HIE) in the United States is one per 1,000 live births, has not improved in recent years, and is associated with increased mortality despite advances in perinatal care. The long-standing practice of withholding enteral nutrition during therapeutic hypothermia (TH) is linked to a concern for decreased intestinal perfusion. While this concern is valid in many infants undergoing TH, some infants may tolerate enteral nutrition and evidence-based literature suggests that this practice improves patient outcomes such as decreased time to reach full enteral feeds and decreased hospital length of stay without increasing morbidity including complications related to decreased intestinal perfusion. Local Problem: The current practice in two neonatal intensive care units (NICUs) in Salt Lake City, Utah is to withhold enteral nutrition during the three-day TH procedure but emerging evidence and the practice of many NICUs suggests that feeding during TH is safe, feasible, and improves patient outcomes. An average of 15.5 infants are admitted to these NICUs annually for TH and have the potential to benefit from a practice change that promotes early enteral nutrition. Methods: A needs assessment was conducted to evaluate current evidence-based literature, the practices of other international and domestic NICUs, the current state of readiness of stakeholders to provide early enteral nutrition during TH, and for the presence of improved readiness with creation of and introduction to a clinical practice guideline (CPG). Interventions: This scholarly project was carried out in four phases. The first phase included an initial survey to evaluate readiness and an in-depth chart review of HIE infants admitted between 2022-2023. The second phase included the creation of an evidence-based CPG. The third phase included a strengths, weaknesses, opportunities, and threats (SWOT) analysis to better understand catalysts and inhibitors to future implementation. The final phase sought to evaluate for a change in stakeholder readiness and to assess the feasibility, usability, and satisfaction of the guideline. Results: The most impactful outcome of this scholarly project was the improved readiness of stakeholders to adopt this change after introduction to current evidence and the CPG. Nearly every respondent in the final survey expressed an increased readiness to provide enteral nutrition during TH in eligible infants and that the CPG was a feasible, detailed, and realistic tool. An in- depth literature review revealed that this practice is occurring in many NICUs with successful patient outcomes. Conclusion: Continuation of this project is recommended including implementation, use of rapid PDSA (plan, do, study, act) cycles to adjust for real-time clinical considerations, and creation of a sustainability plan. While the concern for decreased intestinal perfusion is likely to persist amongst a large portion of stakeholders, emerging evidence should be monitored to observe for necessary recommendation changes and/or further evidence to support this change.

1 Evaluating Provider Readiness to Adopt an Early Enteral Nutrition Guideline for Infants Undergoing Therapeutic Hypothermia: A Needs Assessment McKenna L. Craig and Melinda M. Patterson College of Nursing: The University of Utah April 13, 2024 2 Abstract Background: The incidence of hypoxic-ischemic encephalopathy (HIE) in the United States is one per 1,000 live births, has not improved in recent years, and is associated with increased mortality despite advances in perinatal care. The long-standing practice of withholding enteral nutrition during therapeutic hypothermia (TH) is linked to a concern for decreased intestinal perfusion. While this concern is valid in many infants undergoing TH, some infants may tolerate enteral nutrition and evidence-based literature suggests that this practice improves patient outcomes such as decreased time to reach full enteral feeds and decreased hospital length of stay without increasing morbidity including complications related to decreased intestinal perfusion. Local Problem: The current practice in two neonatal intensive care units (NICUs) in Salt Lake City, Utah is to withhold enteral nutrition during the three-day TH procedure but emerging evidence and the practice of many NICUs suggests that feeding during TH is safe, feasible, and improves patient outcomes. An average of 15.5 infants are admitted to these NICUs annually for TH and have the potential to benefit from a practice change that promotes early enteral nutrition. Methods: A needs assessment was conducted to evaluate current evidence-based literature, the practices of other international and domestic NICUs, the current state of readiness of stakeholders to provide early enteral nutrition during TH, and for the presence of improved readiness with creation of and introduction to a clinical practice guideline (CPG). Interventions: This scholarly project was carried out in four phases. The first phase included an initial survey to evaluate readiness and an in-depth chart review of HIE infants admitted between 2022-2023. The second phase included the creation of an evidence-based CPG. The third phase included a strengths, weaknesses, opportunities, and threats (SWOT) analysis to better understand catalysts and inhibitors to future implementation. The final phase sought to evaluate 3 for a change in stakeholder readiness and to assess the feasibility, usability, and satisfaction of the guideline. Results: The most impactful outcome of this scholarly project was the improved readiness of stakeholders to adopt this change after introduction to current evidence and the CPG. Nearly every respondent in the final survey expressed an increased readiness to provide enteral nutrition during TH in eligible infants and that the CPG was a feasible, detailed, and realistic tool. An indepth literature review revealed that this practice is occurring in many NICUs with successful patient outcomes. Conclusion: Continuation of this project is recommended including implementation, use of rapid PDSA (plan, do, study, act) cycles to adjust for real-time clinical considerations, and creation of a sustainability plan. While the concern for decreased intestinal perfusion is likely to persist amongst a large portion of stakeholders, emerging evidence should be monitored to observe for necessary recommendation changes and/or further evidence to support this change. Keywords: hypoxic ischemic encephalopathy, therapeutic hypothermia, early enteral nutrition, intestinal perfusion, neonatal intensive care unit, feeding guideline 4 Evaluating Provider Readiness to Adopt an Early Enteral Nutrition Guideline for Infants Undergoing Therapeutic Hypothermia Problem Description The incidence of hypoxic-ischemic encephalopathy (HIE) in the United States is one per 1,000 live births, has not improved in recent years, and is associated with increasing mortality rates despite advances in perinatal care (Acun et al., 2022). Local Neonatal Intensive Care Units (NICUs) do not have a protocol establishing the initiation of early enteral nutrition during the three-day therapeutic hypothermia (TH) procedure, and the current practice is to withhold enteral nutrition during this time. Delayed enteral nutrition has been shown to lead to longer use of parenteral nutrition, increased time required to reach full enteral feeds, and prolonged hospitalization (Hu et al., 2022). The current practice may be attributed to lack of published literature and a prior belief that feeding during TH led to increased rates of necrotizing enterocolitis (NEC) (Gale et al., 2021; Alburaki et al., 2022). Current and emerging evidence suggests that feeding during TH leads to improved outcomes without increased morbidity rates including NEC cases and decreases hospital length of stay (Alburaki et al., 2022). Available Knowledge Human breast milk is irrefutably regarded as the optimal nutrition source for neonates (Lyons et al., 2020). It is considered a complete form of nutrition that naturally provides all necessary micro and macronutrients for proper growth, cellular function, and energy. Breast milk also contains an array of bioactive compounds that play a major role in immunity including transfer of antibodies and immunoglobulins to provide defense against pathogens, human milk oligosaccharides which serve as metabolic substrates for growth of beneficial bacteria within the gastrointestinal tract, and micro ribonucleic acids (microRNA) which play a vital role in gene 5 expression and are thought to influence immune system development. The most unique trait of breast milk is its ability to provide commensal and probiotic bacteria. Secondary to microbe transfer during passage through the vaginal canal, human breast milk is regarded as the most integral source for microbial establishment within the neonate and cannot be replicated by infant formula. Formula is an appropriate alternative to breast milk when breast milk cannot be provided due to influential determinants such as low milk supply, personal preference of the mother, employment constraints, and medical complications. While formula serves to provide the basic nutrients for growth and nutrition, it varies widely in micro and macronutrient composition and cannot provide commensal bacteria to the neonatal gut. The practice of adding probiotic supplements to feeding regimens has gained traction but gaps in the literature exist regarding safe and effective use. The benefits of providing enteral nutrition during periods of critical illness have also been described in the literature. However, it is also well known that the metabolic and immune systems of the body are at great risk for experiencing disruption during this time. During periods of acute illness, the priority of the metabolic system is to repair damaged tissue and reduce inflammation (Moltu et al., 2021). If metabolic dysregulation perpetuates within the body, inflammation spreads and the gut microbiome and intestinal permeability demonstrate sensitivity to the rapid fluctuations in homeostasis (Wischmeyer, 2020). This leads to intestinal epithelial disruption which cascades into a release of pro-inflammatory cytokines, cellular apoptosis, and eventual organ failure. Neonates can exhibit these responses during life-threatening conditions such as sepsis, cardiopulmonary compromise, and hypoxic-ischemic events (Moltu et al., 2021). Additionally, researchers have sought to understand gastrointestinal changes in infants with HIE. One study found that 21% of infants with moderate HIE and 33% of infants with severe HIE had 6 decreased intestinal peristalsis, but simultaneously found no difference in bowel wall thickness and perfusion between the two groups (Faingold et al., 2016). Another study found that infants with HIE had an altered gut microbiome which included higher abundance of facultative anaerobes such as the staphylococcus species and lower abundance of the Bifidobacterium genus which is a beneficial microbe (Gala et al., 2022). However, another descriptive study used abdominal ultrasonography to evaluate intestinal perfusion and found that blood flow did not change during the TH process (Sakhuja et al., 2019). Unsurprisingly, this knowledge is the basis for concern about whether to feed infants during periods of critical illness, including HIE. Despite these concerns, the first week of critical illness is accompanied by a notable increase in energy expenditure that requires balanced and appropriate macronutrient delivery (Moltu et al., 2021). Parenteral nutrition is commonly prescribed to meet basic metabolic demands, but minimal enteral nutrition, also known as trophic volume feedings (10-24 mL/kg/day), is imperative to maintain intestinal function and integrity. Hazeldine et al. (2017) summarized current feeding practices during therapeutic hypothermia (TH) in the United Kingdom and illustrated wide variation in the clinician’s approach. For example, only 31% of NICUs had a guideline to establish enteral nutrition during TH and 59% of units opted to feed during TH. However, there was a clinically significant trend in the number of NICUs who were on the verge of starting the practice of providing enteral nutrition during TH (p-value = 0.001). Despite the aforementioned concerns regarding multiorgan dysfunction during periods of critical illness, many well-conducted studies, including randomized control trials, have demonstrated benefits to enteral feeding during TH without increased gastrointestinal complications including NEC. Early enteral nutrition leads to earlier attainment of full enteral 7 feeds and with no increase in feeding intolerance of gastrointestinal complications such as NEC, when compared to delayed enteral nutrition (Hu et al., 2022). Hu et al. (2022) and Kulkarni et al. (2021) found that early enteral nutrition groups required fewer hospitalization days compared to delayed enteral nutrition groups. The feeding approach in these studies varied slightly. Hu et al. (2022) only prescribed breast milk while the study conducted by Kulkarni et al. (2021) allowed for a standard infant formula if breast milk was unavailable. All studies considered for the literature review used minimal enteral nutrition with volumes ranging from 10 to 20 mL/kg/day and all studies stopped enteral feedings if signs of intolerance were evident (Hu et al., 2022; Kulkarni et al., 2021; Alburaki et al., 2022; Gale et al., 2021; Thyagarajan et al., 2014). Rationale The Johns Hopkins Nursing Evidence-Based Practice Model (JHNEBP) was used to guide this Doctor of Nursing Practice scholarly project (Johns Hopkins University and Medicine, 2023). The JHNEBP model is focused on problem solving and takes the clinician through a userfriendly algorithm (Dang et al., 2022). The algorithm starts with inquiry, transitions into data/evidence gathering and translation, and generation of best practice guidelines that ultimately lead to practice improvements. The first step in the JHNEBP is to ask a question (Daemen Library, 2022). This step can be met with the formulation and application of a PICO question which includes identification of a population, intervention, comparison, and outcome. The objective of this step is to describe the problem that needs to be addressed. Establishing this will clarify and direct step two of the practice model. The second step is to gather evidence which is guided by the PICO question. The goal of this step is to identify what is known about the problem at hand. The third step is to critically appraise the evidence obtained in step two and apply it to the original problem's 8 context. This model incorporates rotating reflection to further refine the clinical inquiry, also known as the plan, do, study, act (PDSA) cycle. This scholarly project is focused on evidence synthesis to promote practice change and improvement and fits well into the JHNEBP model. Specific Aims The purpose of this DNP evidence-based scholarly project was to conduct a needs assessment to understand the current state of feeding practices for infants with HIE who are receiving TH, to evaluate the need for and subsequently create an early enteral nutrition guideline, and to perform a SWOT analysis with the goal of identifying barriers and facilitators for future implementation. Methods Context This scholarly project will take place in two urban NICUs. The first clinical site is a Level IV NICU in Salt Lake City, Utah and is located in a free-standing children’s hospital and receives admissions from local delivery hospitals and surrounding states. The second clinical site is a Level III NICU in Murray City, Utah and is in a major referral center. Combined, these NICUs admit approximately 16 neonates with HIE per year. The clinician group between the two hospitals that will be surveyed is comprised of approximately 384 registered nurses, five dietitians, 70 advanced practice providers including neonatal nurse practitioners and physician assistants, and 25 neonatologists. The patient population served is neonates admitted for various medical and/or surgical complexities and their parents/caregivers. Unit leadership is comprised of nurse managers and medical directors who oversee the implementation of and adherence to new policies and guidelines. Individuals who prescribe enteral feeds during TH in the future includes advanced practice providers and neonatologists. This NICU has a Neuro NICU provider group who is currently working on an HIE bundle. The idea of providing enteral nutrition is 9 included in the bundle, but other initiatives such as holding during TH may take precedence over enteral feeds as they are more feasible to accomplish at this time. If adopted, creating an enteral feeding guideline would likely strengthen the HIE bundle. Interventions Phase one of the needs assessment consisted of assessing current clinical practices and stakeholder attitudes toward providing enteral nutrition during TH. This was achieved through a retrospective chart review and survey of stakeholders. A retrospective chart review revealed 31 neonates admitted for HIE and TH admitted in 2022 and 2023 between both facilities. Several data points were evaluated including feeding trends, biomarker trends, and identification of infants who would have qualified for early enteral nutrition according to evidence-based guidelines in the literature. A survey was conducted to elicit current attitudes and knowledge of early enteral nutrition during TH and facilitators and barriers to future practice change. The second phase of the needs assessment was to develop a feeding guideline and introduce it to stakeholders. The initial survey conducted asked stakeholders which clinical indicators should be considered for the inclusion and exclusion criteria of the guideline. A robust literature review was then conducted to identify the limits of the identified clinical indicators. Benchmarking with eight healthcare organizations who currently provide enteral nutrition during TH was performed to understand their clinical practice guidelines including feeding volume, frequency, and milk type. The findings of the literature review and information gathered during benchmarking with other NICUs was then synthesized to build the feeding guideline. Next, the guideline was presented to the stakeholders by way of virtual and in-person means along with findings of the literature review. 10 The third phase was to perform a SWOT (strengths, weaknesses, opportunities, and threats) analysis. The SWOT analysis was creating by evaluating all data gathered up to this point including results of the initial survey, benchmarking, chart review trends, literature review findings, and the creation of the clinical practice guideline. The SWOT analysis findings were revealed to stakeholders through virtual and in-person communication. The final phase was to evaluate the feasibility, usability, and satisfaction responses to the feeding guideline. This was achieved through dissemination of a final survey to stakeholders to reevaluate readiness to adopt this change and barriers to future implementation. Study of the Interventions Evaluating the response to this needs assessment and quality improvement project occurred in several steps. The goal of performing a retrospective chart review was to increase the stakeholders’ understanding of the overall clinical stability and relative gut perfusion of neonates admitted to the NICU for TH, along with revealing current feeding practices for this specific patient population. The initial survey provided value by revealing the stakeholders’ baseline knowledge of the benefits of enteral nutrition and readiness to adopt enteral nutrition during TH. Stakeholders were asked to list biomarkers that they rely on to determine a neonate’s level of clinical stability. These items directly influenced the creation of the inclusion and exclusion criteria section of the CPG. Reaching out to NICUs around the United States was a powerful indicator of the how care for neonates with HIE is evolving. The combination of these results, along with internal clinician expertise and external evidence, built the foundation of the clinical practice guideline. The results of the initial survey, education regarding the benefits of early enteral nutrition, and the developed guideline were then presented to stakeholders. The SWOT analysis provided insight into the catalysts and obstacles to future adoption of this CPG. A final 11 survey was conducted to evaluate whether awareness of emerging evidence and introduction to a CPG improved staff readiness to adopt this change. Measures The chart review evaluated several data points including: gestational age at birth, Sarnat score (mild, moderate, or severe HIE), respiratory support at 24 hours of life, presence of persistent pulmonary hypertension, hemodynamic stability (heart rate and blood pressure trends between 24-72 hours of life), the use of vasopressor/inotropic support, the presence of seizure activity and required intervention, serum lactate level at greater than 24 hours of life, hematocrit, alanine transaminase (ALT), aspartate transaminase (AST), and creatinine values at greater than 24 hours of life, presence of coagulopathy, the need for blood product transfusion, urine and stool output, hospitalization days, and day of life when enteral nutrition was provided. This data was then evaluated with an internal expert group to determine the estimated gut perfusion of each patient reviewed. The pre-implementation survey included nine questions consisting of two demographics questions, six multiple-choice questions, and one open-ended question (Appendix A). The postimplementation survey included seven questions consisting of two demographics questions, four multiple-choice questions, and one open-ended question (Appendix B). The relationship between the respondents’ demographics and readiness to adopt this practice change provided context for the future success or failure of this project. Analysis Quantitative data evaluated by averaging years of experience in the NICU, identification of NICU role, and data points regarding readiness to adopt this change. Qualitative data included one open-ended question in the pre-implementation survey asking respondents to identify desired 12 inclusion and exclusion criteria for the guideline, and one open-ended question in the postimplementation survey asking respondents to provide constructive feedback for the guideline. Quantitative questions were included in the post-implementation survey to understand whether or not the respondent believed their stance had changed because of the education and guideline provided through this project. Ethical Considerations This project involved neonates which is considered a vulnerable patient population. It included a needs assessment and creation of a theoretical guideline for possible future use. Therefore, ethical considerations for the patient’s benefit was not applicable including inclusion or exclusion from use of this guideline. Additionally, the review of patients admitted for TH was performed retrospectively which negated the aspect of equal and fair application of the guideline. There were no conflicts of interest to disclose. Results Fifty-six respondents out of 484 stakeholders (12% return rate) participated in the initial survey. The majority of respondents were nursing staff (N=35) with less than five years of experience (Table 1). Physicians (N=7), advanced practice providers (N=13), and a dietitian (N=1) responded as well. Thirty-seven (66%) stakeholders were unsure if infants should receive enteral nutrition during TH (Figure 1). All (N=20) prescribing providers, who will be the primary users of this guideline, reported being open to making this change now or in the future if evidence emerges to support it. In fact, most respondents would like to see more evidence including Level I and Level II evidence. The majority of staff (N=51, 91.1%) reported a concern for altered or decreased intestinal perfusion as the primary reason they are hesitant to provide enteral nutrition during TH (Figure 2). Others (N=2, 3.6%) reported being open to this change if a risk-benefit equation were defined and recent literature supports it. Respondents were asked to 13 share their opinion regarding the comparison between the intestinal perfusion of infants with HIE and infants who currently receive early enteral nutrition such as those with congenital heart disease (CHD) and those who are extremely low-birth weight (ELBW). Of 56 respondents, 51.8% (N=29) believe all three patient types have similar perfusion, 26.8% (N=15) believe infants with HIE have better intestinal perfusion than CHD and ELBW infants, and 21.4% (N=12) believe infants with HIE have worse intestinal perfusion than CHD and ELBW infants. The final survey question was open-ended and asked participants to list which clinical criteria they would like to see incorporated into the feeding guideline. Responses included: hemodynamic status, presence of coagulopathy, HIE severity, presence of seizure activity, sedation requirements, intestinal perfusion (as measured by near-infrared spectroscopy (NIRS)), severity of lactic acidosis, end-organ perfusion (as measured by urine and stool output), and required respiratory support. The guideline was then created to incorporate the feedback received in the preimplementation survey (Appendix C). The guideline is intended to help the clinician determine eligible infants for enteral nutrition during therapeutic hypothermia. Four risk zones were identified based on indicators of clinical stability and presumed end-organ perfusion. In Zones One through Three, it is assumed that the patient is otherwise clinically stable aside from the criteria mentioned such as increased need for respiratory support, varying degrees of cardiovascular support, degree of lab value abnormality, ability to control seizure activity if present, etc. Zone One is defined as no risk and these infants should be considered for enteral nutrition around 24 hours of age. Zone Two is defined as low-risk and enteral nutrition should be considered around 24 to 48 hours of life. Zone Three is defined as medium-risk and enteral nutrition should be considered around 48 to 72 hours of life. Zone Four is defined as high-risk 14 and these infants should not be considered for enteral nutrition during TH. The guideline user is instructed to start by evaluating their patient for the presence of identified clinical indicators on the left-hand side of the table, moving from top to bottom. Next, the user shall refer to the zone criteria associated with the clinical indicator at the top of the table. As described in the zones shown in Appendix C, if the patient exceeds the number of acceptable clinical indicators in a particular zone, they automatically advance to the next zone. Next, an in-depth chart review was performed on 31 infants who were admitted to the NICUs for HIE from 2022-2023. Twenty-one were admitted to the Level III NICU and 10 were admitted to the Level IV NICU. The feeding guideline was applied to each infant by two users and the results were compared for consistency of the tool. Each user generated similar zone findings for each patient and were as follows: one infant in Zone One, eleven infants in Zone Two, two infants in Zone Three, and 15 infants in Zone Four. According to this data, 45% of infants would have qualified for enteral nutrition during TH within the first 24 to 72 hours of life (N=14). Infants were most often categorized as a Zone Four for the following clinical indicators of instability: hemodynamic instability, use of inhaled nitric oxide (iNO) for persistent pulmonary hypertension, presence of coagulopathy requiring multiple transfusions, signs of multi-organ dysfunction including profound lactic acidosis, persistently or markedly elevated liver enzymes and/or renal function tests, and use of extracorporeal membrane oxygenation (ECMO). An educational handout was provided to all stakeholders that included a summary of the literature review findings, initial survey findings, and a SWOT analysis overview (Appendix D). The final survey was then disseminated and thirty-seven respondents out of 484 stakeholders (7.6% return rate) participated. Nurses responded in the greatest numbers (N=21) followed by 15 APPs (N=9), physicians (N=6) and dietitians (N=1) (Table 2). When asked how the stakeholders’ stance had changed after reviewing the literature review, educational handout (Appendix D), and feeding guideline (Appendix C), all but one respondent stated that they were more open to providing enteral nutrition during TH (Figure 3). Every respondent (N=37, 100%) reported that the provided guideline included the indicators of clinical stability that they would review when considering providing enteral feeds during TH. When asked if the guideline was a user-friendly and feasible tool, all but one stakeholder (N=36, 97.3%) stated ‘yes,’ and one respondent requested more detail regarding feeding volumes and more specific “high” and “low” lab values (i.e. AST, ALT, BUN, creatinine, lactate). Discussion Summary Results of this needs assessment revealed that a gap in current practice exists but that providers are open to learning more about emerging evidence regarding feeding during TH. Creation of an evidence-based CPG was possible with the help of many level I and II research articles and initial survey responses regarding desired inclusion and exclusion criteria. The retrospective chart review identified the frequency of NICU admissions for TH and that by using the developed guideline, nearly half of all infants between the two NICUs would have qualified for early enteral nutrition compared to the current standard of starting feeds after a minimum of 78 hours of life (including cooling and rewarming time). The most impactful outcome of this evidence-based project was the improved readiness of stakeholders to adopt this change after reviewing the provided information. Therefore, the specific aims of this needs assessment have been achieved. 16 Interpretation Unsurprisingly, NICU providers’ primary hesitation to provide feeding during TH stems from concerns of decreased intestinal perfusion during TH in infants with HIE. Despite this initial and likely ongoing concern, the post-survey revealed that stakeholders demonstrated an improved readiness to make this practice change after reviewing evidence-based literature, including the fact that many NICUs feed during TH without increased morbidity rates, and introduction to a user-friendly and feasible guideline. One question included in the initial survey revealed that the majority of providers believed that infants with HIE have similar or better intestinal perfusion than those who are ELBW or have CHD. The context of these findings is significantly impactful on feasibility as both NICUs involved in this project currently feed ELBW and CHD infants with CPGs in place. In regard to sustainability of this project, the conducted SWOT analysis revealed the potential catalysts and inhibitors to future implementation and success of the developed guideline. The primary strengths of this project are abundant. The proposed change is a guideline and not a protocol. This allows for continued provider judgment on a case-by-case basis. The created guideline appears to be unique as the inclusion criteria section of other studies was sparse and simply included qualification for TH and hemodynamic stability. This practice change appears to be highly feasible as many centers feed during TH without increased morbidity and the two NICUs included in this project feed other infants with potentially decreased intestinal perfusion without increased complications (ELBW and CHD infants). The selected NICUs have well-trained and experienced staff who are capable of determining which infants should be considered for feeding during TH based on overall clinical stability. Technology such as NIRS exists to aid in the estimation of relative gut perfusion and changes that may be noted during TH. 17 Finally, introduction to this guideline, along with evidence-based literature, proved to be an effective catalyst for improving stakeholders’ readiness to make this practice change. The primary weaknesses of this project include perceived lack of current evidence as described by stakeholders and technology gaps. The initial survey revealed that while staff are open to this change, they would like to see more level I and II evidence along with more in-depth risk-benefit equations. This suggests that this change is unlikely to occur at this time if more compelling evidence is not published. Despite tools such as lab analysis and advanced technology (NIRS), it is not possible to completely describe gut perfusion and associated changes in HIE infants during TH. This leads to significant hesitation to provide feeds during TH and appears to be the primary inhibitor of adoption of the guideline. Opportunities related to this clinical practice change include the possibility of decreasing patient discomfort related to not receiving any enteral nutrition during TH and decreasing the time required to reach full enteral feeds. The downstream effect of reaching full enteral feeds sooner is the potential for decreased hospital length of stay and decreased costs as the primary impact. Additionally, exposure to total parenteral nutrition and subsequent liver damage may decrease if infants are able to tolerate full enteral nutrition sooner. The final portion of the SWOT analysis included identification of threats such as the large scale variation in practice. The literature review revealed that this occurs on the individual, institution, and international scale. The initial survey concluded that this trend is present among the surveyed stakeholders as well. Despite introduction to evidence-based articles and a potential guideline, variation in readiness may continue to serve as the primary threat to future implementation. 18 Limitations The primary limitation of this scholarly based project was time constraint. While the initial phases of reviewing current evidence and assessing the need for and subsequently creating a guideline were successfully completed, the lack of time did not allow for implementation and creation of a sustainability plan. It is recommended that phase two of this project includes implementation along with additional adjustments to the guideline using the PDSA cycle and creation of a sustainability plan. Another limitation is the fact that the conducted surveys did not have matched responses. This makes it difficult to conclude with certainty that the participants of the initial survey had a change in readiness. Conclusions In conclusion, this scholarly project sought to describe the need for and subsequently create an early enteral nutrition guideline for infants with HIE undergoing TH. This practice is occurring in many centers both foreign and within the United States. Provider readiness to adopt this change varies and has perpetuated the long-standing practice of withholding enteral nutrition during the three-day TH procedure. Emerging evidence suggests positive outcomes such as decreased time to reach full feeds and decreased hospital length of stay without increased morbidity related to decreased intestinal perfusion during TH. The conducted needs assessment concluded that stakeholders have an ongoing concern regarding the clinical stability of these patients but express an increased readiness to adopt a CPG after review of emerging evidence and introduction to a feasible guideline. Many providers expressed excitement for the possibility of adopting this change and an interest in future implementation and sustainability of this project. An executive summary was created to emphasize the importance and impact of this scholarly project (Appendix E). 19 Acknowledgments I would like to expressly thank individuals who played a large role in the success of this scholarly project. Thank you to Dr. Melinda Patterson who served as my Project Chair. Your unwavering encouragement powered me through the last eight months and I look up to you as a leader and mentor. Thank you to Dr. Kim Friddle for your wisdom, guidance, and support over the last two and a half years as the Neonatal Nurse Practitioner Program Director and Sponsor of this project. I admire your wealth of knowledge and appreciate you sharing it with our cohort. To Dr. Tara DuPont who served as the Content Expert of this project, thank you for believing in my vision and supporting me with your time, expertise, and encouragement. You have pushed me to believe that making big changes in the NICU setting is possible and worthwhile. To Dr. Julie Gee, thank you for spending many hours providing individualized direction for the betterment of this project and manuscript. To my NICU colleagues, thank you for participating in my surveys. This project would have been impossible without your constructive feedback. Finally, thank you to my cohort, mentors, family, boyfriend, and friends. I could not have made it through the last few years without your love, friendship, and support. 20 References Acun, C., Karnati, S., Padiyar, S., Puthuraya, S., Aly, H., & Mohamed, M. (2022). Trends of neonatal hypoxic-ischemic encephalopathy prevalence and associated risk factors in the United States, 2010 to 2018. American Journal of Obstetrics and Gynecology, 227(5). 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DOI: 10.1097/CCM.0000000000003965. 23 Table 1 Demographics of Needs Assessment Participants Initial Survey Characteristic Role in the NICU N % Dietitian 1 1.8% Registered Nurse 35 62.5% NNP or PA 13 23.2% Physician 7 12.5% 0-5 years 16 28.6% 6-10 years 16 28.6% 11-15 years 5 8.9% 16-20 years 9 16.1% >20 years 10 17.9% Years of Experience as NICU Provider 24 Table 2 Demographics of Needs Assessment Participants Final Survey Characteristic Role in the NICU N % Dietitian 1 2.7% Registered Nurse 21 56.8% NNP or PA 9 24.3% Physician 6 16.2% 0-5 years 5 13.5% 6-10 years 11 29.7% 11-15 years 4 10.8% 16-20 years 7 18.9% >20 years 10 27% Years of Experience as NICU Provider 25 Figure 1 Current Readiness to Feed During Therapeutic Hypothermia, Described by NICU Providers No 18% Yes 16% Unsure 66% 26 Figure 2 Primary Reason for Hesitation to Provide Feeds During TH, Described by NICU Providers 60 50 40 30 20 10 0 Altered Gut Perfusion (91.1%) Risk-Benefit Equation Not Established (3.6%) No Hesitation (3.6%) Not Enough Info (1.8%) 27 Figure 3 Current Readiness to Feed During Therapeutic Hypothermia After Introduction to Current Evidence, Initial Survey Findings, and Potential Guideline, As Described by NICU Providers 40 35 30 25 20 15 10 5 0 Yes, I am more open to feeding during cooling (94.6%) No, I am still hesitant to feed during No, I already believed in feeding cooling (2.7%) during cooling (2.7%) 28 Appendix A Early Enteral Nutrition During Therapeutic Hypothermia – Pre-Survey The goal of this survey is to understand the current beliefs surrounding the practice of providing early enteral nutrition during therapeutic hypothermia. The results of this survey will be used to guide the creation of a feeding guideline for possible future use. Thank you for taking the time to complete this survey. Your responses are appreciated! Question 1: What is your role in the NICU? Answer options: Dietitian Registered Nurse; Advanced Practice Provider (NNP or PA); Physician Question 2: How many years of experience do you have as a NICU provider? Answer options: 0-5 years; 6-10 years; 11-15 years; 16-20 years; >20 years Question 3: On a scale from 1 to 5, how well do you understand the benefits of early enteral nutrition? Answer options: 1 – no understanding; 2 – minimal understanding; 3 – good understanding, 4 – great understanding; 5 – complete understanding Question 4: Do you believe neonates should receive enteral nutrition during therapeutic hypothermia? Answer options: Yes; No; Unsure Question 5: Do you believe there is enough available evidence to support enteral nutrition during therapeutic hypothermia? Answer options: Yes; No; Unsure Question 6: If any, what is your hesitation to provide enteral nutrition during therapeutic hypothermia? Answer options: Not enough evidence to support this change; Concern for decreased intestinal perfusion; Unnecessary to provide early enteral nutrition during therapeutic hypothermia; Other (please explain) Question 7: If you believe there is a lack of evidence to support this change, what level of evidence would you need to see published to feel comfortable beginning enteral nutrition during therapeutic hypothermia? Answer options: Level I (randomized-controlled trials); Level II (some degree of investigator manipulation and some manipulation of an independent variable, but lacks randomization); Level III (studies lack manipulation of an independent variable; can be descriptive, comparative, correlational, cross-sectional); Not applicable, I believe there is enough evidence to support this change now Question 8: In your opinion, how do infants with moderate to severe hypoxic-ischemic encephalopathy (HIE) differ from those who are extremely low-birth weight (ELBW) or those who have congenital heart disease (CHD), in terms of intestinal perfusion? Answer options: Infants with HIE have better intestinal perfusion than ELBW infants and those with CHD; Infants with HIE have worse intestinal perfusion than ELBW infants and those with CHD; Infants with HIE have similar intestinal perfusion as ELBW infants and those with CHD Question 9: Which clinical details would you like to be considered in the inclusion/exclusion criteria section of an early enteral nutrition during therapeutic hypothermia guideline (I.e. hemodynamic status, respiratory support, presence of coagulopathy, presence of seizure activity, etc.)? Answer option: open text box for responses 29 Appendix B Early Enteral Nutrition During Therapeutic Hypothermia – Post-Survey Question 1: What is your role in the NICU? Answer options: Dietitian; RN; APP (NNP or PA); Physician Question 2: How many years of experience do you have as a NICU provider? Answer options: 0-5 years; 6-10 years; 11-15 years; 16-20 years; >20 years Question 3: Did you take the pre-implementation survey associated with this project? Answer options: Yes; No; Unsure Question 4: After reviewing the provided information and literature review, has your stance on feeding during cooling changed? Answer options: Yes, I am more open to feeding during cooling; No, I am still hesitant to feed during cooling; No, I already believed that infants should receive enteral feeds during cooling Question 5: After reviewing the guideline, does it seem like a user-friendly and feasible tool for future use? Answer options: Yes; No (please provide a short explanation of your feedback for improvement) Question 6: Does the guideline include the indicators of clinical stability that you would review if considering providing enteral nutrition during cooling? If no, please list clinical indicators that you believe are missing from the guideline. Answer options: Yes; No (please list) Question 7: Please provide any constructive feedback you may have for this project. Thank you! Answer options: open text box for responses 30 Appendix C Purpose: This clinical practice guideline is intended to assist the clinician in determining eligible infants for enteral nutrition during therapeutic hypothermia. How to use this guideline: Four risk zones have been identified based on indicators of clinical stability and presumed end-organ perfusion. In zones 1-3, it is assumed that the patient is otherwise clinically stable aside from the criteria mentioned in the chart below. This includes but is not limited to: overall hemodynamic stability, absence of persistent metabolic/lactic acidosis, adequate urine output, and absence of obvious abdominal compromise (i.e. distention, discoloration, bilious emesis, etc.). Start by evaluating for the presence of the identified clinical indicators on the left hand side. Next, refer to the Zone criteria at the top of the table to determine zone placement. As described, if the patient exceeds the defined clinical indicators in a particular zone, they automatically advance to the next zone. ZONE 1 (no-risk): consider providing enteral nutrition around 24 hours of age ZONE 2 (low-risk): consider providing enteral nutrition around 24-48 hours of age ZONE 3 (medium-risk): consider providing enteral nutrition around 48-72 hours of age ZONE 4 (high-risk): do not provide enteral nutrition during therapeutic hypothermia 31 32 Appendix D 33 34 35 36 Appendix E Evaluating Provider Readiness to Adopt an Early Enteral Nutrition Guideline for Infants Undergoing Therapeutic Hypothermia: A Needs Assessment - Executive Summary Summary Neonatal Intensive Care Units (NICU) frequently admit infants for hypoxic-ischemic encephalopathy (HIE) and the need for therapeutic hypothermia (TH). The current practice in two NICUs in Salt Lake City, Utah is to withhold enteral nutrition during the three-day TH procedure but emerging evidence and the practice of many NICUs suggests that feeding during TH is safe, feasible, and improves patient outcomes. This needs assessment revealed that after introduction to evidence-based literature and a created guideline, the majority of stakeholders expressed an increased readiness to adopt this change. Background The incidence of HIE in the United States is one per 1,000 live births, has not improved in recent years, and is associated with increased mortality despite advances in perinatal care. The long-standing practice of withholding enteral nutrition during TH is linked to a concern for decreased intestinal perfusion. While this concern is valid in many infants undergoing TH, some infants may tolerate enteral nutrition and evidence-based literature suggests that this practice improves patient outcomes such as decreased time to reach full enteral feeds and decreased hospital length of stay without increasing morbidity including complications related to decreased intestinal perfusion. The purpose of this scholarly project was to understand the current state of feeding practices in the selected clinical sites and evaluate the need for and subsequently create an early enteral nutrition guideline. Deliverables This needs assessment included a robust literature review, an initial survey of stakeholders, a retrospective chart review of every infant admitted to the two NICUs between 2022-2023, creation of a clinical practice guideline (CPG), and a final survey of stakeholders to evaluate for a change in readiness and feasibility of the guideline. The products of this project include: • A refined understanding of the current state of feeding during TH on a large scale • An in-depth description of stakeholder readiness to adopt this change • A unique CPG developed to include inclusion and exclusion criteria as described by stakeholders • A comprehensive SWOT (strengths, weaknesses, opportunities, and threats) analysis for implementation Results and Value The most impactful outcome of this scholarly project was the improved readiness of stakeholders to adopt this change after introduction to current evidence and the CPG. Nearly every respondent in the final survey expressed an increased readiness to provide enteral nutrition during TH in eligible infants and that the CPG was a feasible, detailed, and realistic tool. Additionally, the majority of stakeholders expressed that they believe infants with HIE have similar or better intestinal perfusion than infants who are extremely low-birth weight (EBLW) or who have congenital heart disease (CHD). Feeding guidelines are currently utilized for ELBW and CHD infants in the two involved NICUs, further emphasizing the feasibility of this change. 37 Recommendation Continuation of this project is recommended including implementation, use of rapid PDSA (plan, do, study, act) cycles to adjust for real-time clinical considerations, and creation of a sustainability plan. While the concern for decreased intestinal perfusion is likely to persist amongst a large portion of stakeholders, emerging evidence should be monitored to observe for necessary recommendation changes and/or further evidence to support this change.