Research Proposal on Formula vs. Breastfeeding Essay Example

In newborns, how does ever breastfeeding compared to formula feeding affect chances of childhood Leukemia? Are you a new or expecting mom that still cannot quite figure out whether breastfeeding or formula feeding your child is the best option? There are many pros and cons that may outweigh the others when considering breastfeeding versus bottle feeding your child. Whether you believe you should breastfeed, formula feed or a combination of both, the chances of childhood Leukemia are what we are going to focus on in this proposal. This is important to nursing because as providers and nurses we need to be educating expecting and new mothers on the most up to date and accurate research to ensure the highest quality of life for their children.

Why Breastfeed? 

Breastfeeding is not for everyone, but there are many reasons women choose to do so. Breastfeeding gives newborns the opportunity to consume not only proteins, fats and sugars that are necessary for them to grow, but breast milk also provides vitamins, minerals and antibodies that further help with their immunity. This is one of the many benefits that breast milk has over formula. There are no contents in formula that can help protect an infant from different diseases or infections. Healthy Children’s website states, “If you develop a cold while breastfeeding, for example, you are likely to pass the cold germs on to your baby—but the antibodies your body produces to fight that cold also will be passed on through your milk.

These antibodies will help your infant conquer the cold germs quickly and effectively and possibly avoid developing the cold altogether” (Breastfeeding Benefits Your Baby's Immune System, 2019). Not only does breastmilk provide necessary nourishment as well as aiding in immunity for your infant, but there is also recent research that supports how 22 countries confirm that exclusively breastfeeding has shown a reduction in childhood obesity (Kendall, 2019). Overall, moms also benefit from this in that they create a special bond with their child. It is clear that there are many benefits for infants when breastfed, but how long should they be fed breast milk before officially switching over to regular milk and solid foods?

Breastfeeding Timeline

Initiation of breastfeeding can be difficult for new mothers, as well as maintain that duty throughout the recommended timeframe. The CDC recommends, “Mothers should be encouraged to breastfeed their children for at least 1 year. The longer an infant is breastfed, the greater the protection from certain illnesses and long-term diseases. The more months or years a woman breastfeeds (combined breastfeeding of all her children), the greater the benefits to her health as well” (CDC, 2019). This being said, a 2015 study on 120 infants that were diagnosed with either childhood leukemia either acute lymphocytic leukemia (ALL) or  acute myeloid leukemia (AML) between 1-15 years old was conducted to test whether the diagnosis was related to the time the child was breastfed or not breastfed at all. “Breastfeeding for at least 6 months was associated with reduced risk of acute leukemia among children diagnosed between age 1 and 14 years of age. Exclusive breastfeeding beyond 6 months showed a statistically significant reduced risk of childhood acute leukemia and also continued breastfeeding along with complementary feeds for at least 1 year was found to be highly significant in reducing the risk of childhood acute leukemia” (Lingappa, 2018).

Formula Feeding

Contrary to breastfeeding, mothers who choose to formula feed their newborns may be at a disadvantage in terms of their infants’ health and immunity. Another study conducted in 2014 of 142 children ages 1-14 years focused on formula feeding compared to exclusively breastfeeding. The results showed, “milk formula feeding and later age at the introduction of solid foods as novel potential risk factors for pediatric ALL. Existing research on the relationship between formula feeding and serum IGF-1 in early life and the role of IGF-1 in leukemogenesis may explain the association of formula feeding with risk of ALL” (Schraw, 2014). Although it is not stated that formula feeding your newborn will cause Leukemia, there is still a relationship associated between the two. Newborns have a very low immunity and require many different forms of nutrition, in that they need the antibodies from breast milk that help build up their immune system.

What Does This Mean?

As you can see, newborns need proper nutrition to grow healthy as well as develop a strong immunity to avoid unnecessary diseases and infections. When new mothers decide between breastfeeding and formula feeding they are overall choosing what kind of nutrition their infant is receiving. Breast Milk provides an abundance of necessary fats, proteins as well as antibodies. Artificial formula on the other hand does not have those antibodies. Infants that are exposed to exclusive formula feedings are more susceptible to occurring childhood leukemia later in life. Although there are a couple studies provided, moving further, we will discuss in detail what these studies and literature actually mean overall. Diving deeper, more examples of why breast milk over formula may be the healthier option for newborns in correspondence to developing childhood leukemia will also be discussed.  

Ethical Considerations and HIPAA

As a new or expecting mother, every physician should be talking to you about breastfeeding and what will be the best approach for you and your baby, however the decision is ultimately up to you. There are many things to consider when making the choice to breastfeed versus formula feed your newborn. Incorporating evidence based practices and considering ethical concerns into the education for new and expecting mothers is extremely important.

Evidence Based Practice

When considering the many risks that can be associated with formula feeding a newborn, pediatricians and other doctors involved in the care of expecting mothers are required to educate patients on the importance of breastfeeding. According to The Baby-Friendly Hospital Initiative (BFHI) program, there are ten steps for successfully breastfeeding which are all evidence based hospital practices. “The BFHI program leads to increased breastfeeding initiation, continued breastfeeding, and higher exclusivity rates. Hospitals implementing more of the Ten Steps seem to have greater success in a dose dependent manner, achieving better results in breastfeeding initiation, continuation, and exclusivity” ("Evidence Based Support For Breastfeeding", 2015).

The World Health Organization revised these ten steps in 2018. To sum these up, steps one through three are to “Comply fully with the International Code of Marketing of Breast-milk Substitutes and relevant World Health Assembly resolutions”, and to guarantee that the staff is well educated and proficient in the skills to reinforce proper breastfeeding, as well as discussing how and why pregnant women should be breastfeeding ("Ten steps to successful breastfeeding”, 2018). Steps four through six can be condensed into the discussion of the importance of skin-to-skin contact, supporting new mothers and how to manage any difficulties as well as stressing the importance of only using breast milk unless you are told by a physician otherwise ("Ten steps to successful breastfeeding”, 2018). 

The last four evidence based practice steps involve encouraging mother to practice rooming-in 24 hours a day, educating on how to respond and recognize cues for feeding, as well as educating on the risks of feeding bottles, teats and pacifiers, and finally preparing for discharge and ensuring the mother has the proper information for any follow-up questions or concerns ("Ten steps to successful breastfeeding”, 2018). These ten steps may seem overwhelming for a clinician, however incorporating these evidence based practice guidelines is crucial in ensuring all mothers are educated in the most proficient way possible. 

Risks

Risks to consider in a study involving the determination of whether formula feeding an infant puts them at higher risk for childhood leukemia is tricky. This study will not be conducted in a way that puts any child at risk for developing any illness or be put in any kind of danger. Furthermore, there are ethical considerations that go hand and hand with this kind of study. Taking surveys from a pool of mothers that did and did not breastfeed, as well as surveys from mothers with a child that has been diagnosed with childhood leukemia is the best way to approach this in an ethical and safe manner. Comparing these results ensures that we are not purposely putting a child at risk for any kind of harm (disease). As mentioned above there are specific guidelines that doctors should be incorporating into their patient education when it comes to whether a mother should breastfeed or not.

In a 2018 study of 24 mothers who formula fed their child was conducted to see the results of why they chose to formula feed over breastfeed. These were the results, “Formula feeding practice is influenced by a number of factors, including the infant’s cues of hunger and satiety, other external cues such as the amount of milk in the bottle, and external sources of advice such as that provided on the infant formula tin and other forms of marketing. The current public health and health professional messaging regarding the avoidance of infant formula creates an environment where some mothers may feel unsupported thus discouraging parent’s access to health professional advice or support” (Appleton, 2018). According to this study there were many different external reasons why mothers chose to formula feed, one of them being inadequate education from their doctor. Many stated that when they questioned the doctor on formula feeding they seemed to disregard them and continue talking about why breastfeeding is better. Of course there is less risk for infections, diseases and other health complications when choosing to breastfeed, however doctors also need to be educating parents about risks and benefits regardless which option they choose. 

HIPAA Considerations and Consent

Obeying HIPAA and other ethical considerations is priority in any study conducted. Any subjects in this study will be fully protected under all HIPPA regulations. “The Privacy Rule permits covered entities under the Rule to determine that health information is de-identified even if the health information has been assigned, and retains, a code or other means of record identification, provided that the code is not derived from or related to the information about the individual; the code could not be translated to identify the individual; and the covered entity under the Privacy Rule does not use or disclose the code for other purposes or disclose the mechanism for re-identification” (Greenberg, 2018). Protection of patient/ participant information is a top priority. 

Informed consent also plays a role in this study, each participant interviewed will be educated on every single detail of their involvement with the study. Because informed consent is not just a form to fill out it is a process all together, different things go into this step. “It is essential that consent forms be written in plain language that research subjects can understand. The consent document should always be revised if there are changes in the study that might affect the participant or when additional information will improve the consent process. In addition, the consent form should not contain any exculpatory language. That is, subjects should not be asked to waive (or appear to waive) any of their legal rights, nor should they be asked to release the investigator, sponsor, or institution (or its agents) from liability for negligence” (“Informed Consent”, 2019). All participants will be informed before, during and after. Informed consent is a process because it ensures that the participants are able to ask any and all questions they may have about the study as well as have the opportunity to back out if they do not feel comfortable. HIPPA regulations as well as informed consent and full disclosure are all things that need to be top of the list before, during and after a research study to ensure patient confidentiality does not get violated, and all participants fully understand what they are being involved in. 

Overview

All in all, it is clear that participant confidentiality, informed consent, basic ethical considerations are all extremely important to obey when doing any kind of research study. These topics all go hand and hand with The Belmont Report that was established in 1979. The Belmont Report is “A statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects” (Office for Human Research Protections, 2018). This ultimately protects participants in research studies in similar ways that were previously discussed. Following evidence based practices and ethical considerations, ensuring no breach in confidentiality as well as informed consent and full disclosure all need to be followed in research studies. 

Literature Review

Because this proposal is for future research, it is important to examine and interpret previous and similar studies that have been conducted. Moving forward, discussing these studies and figuring out potential areas that should or can be revised is crucial for ensuring future studies can be regulated and managed in the proper manner. Using these studies to help evolve a new one can aid in providing patients with the most up-to-date, statistical and knowledgeable information to ensure the best form of education material. 

Breastfeeding and Leukemia

The relationship between formula feeding and childhood leukemia is a topic that needs to be discussed between an expecting mother and their physician. Multiple studies have been conducted to show this relationship of how formula feeding a newborn may have an impact on their chances of being diagnosed with early childhood leukemia. The first study we are going to discuss was conducted by Efrat Amitay. Overall, there were “9650 leukemia cases and 16,526 control individuals for which there were breastfeeding data that could be analyzed” (Amitay, 2015). With such a large number of cases they were able to include a great number of controls as well as break down the study to figure out how many of these leukemia cases were breastfed versus formula fed and how long both occurred. The results from this were that, “14% to 20% of all childhood leukemia cases may be prevented by breastfeeding for 6 months or more, a highly accessible and low-cost public health measure” (Amitay, 2015). 

Furthermore, this study also touches on the importance of breastfeeding over formula feeding. Breastfeeding provides your infant with many different antibodies which helps build a stronger immunity to help protect against diseases and cancers such as childhood leukemia. “Infant formulas cannot mimic the array of protective properties of breast milk, which fits the infant both species-wise (eg, human milk vs cow milk) and individually owing to the dyadic connection between a mother and her baby” (Amitay, 2015). This statement alone sums up why formula milk simply cannot compare to breastmilk. 

Demographic Characteristics 

Conducting studies to figure out the similarity between formula feeding a child and the likelihood that they will occur a form of childhood leukemia can be extremely difficult in that there are many different demographic characteristics that play a role. A 2015 study by Greenop and many others did a great job with incorporating the many different factors that need to be addressed to create the most accurate results possible. There were two separate studies done, the first looked at children diagnosed with acute lymphoblastic leukemia (ALL), and the second looked at children diagnosed with childhood brain tumors (CBT). 

For the purpose of this paper, we will be focusing solely on the children diagnosed with ALL. “For ALL, 19 case and 23 control children with birth defects were excluded, leaving 322 cases and 679 controls for analysis” (Greenop, 2015). This study incorporated a survey for parents to fill out with a series of questions asking about what the child was fed (breast milk vs. formula), and how long they were fed given options. Also included in this survey were different demographic characteristic questions such as state of residence, mother’s education, ethnicity, mothers age at time of birth, as well as if the child was ever in the neonatal intensive care unit and if so for how long (Greenop, 2015). Using these different questions in the survey greatly added to the information the researchers gathered and how different factors could play a role in the diagnosis of ALL. 

The results from this study concluded that there is a reduced risk of ALL with breastfeeding however, “no evidence of a dose-dependent relationship with duration of breastfeeding or exclusive breastfeeding” (Greenop, 2015). They also figured out that “formula feeding (of 1 mo duration) was associated with an increased risk of ALL when started within 14 days of birth” (Greenop, 2015). When addressing some of the demographic questions asked, Greenop states, “ALL case children were more likely to be firstborn than control children (50.5% vs. 41.1%) while control mothers were more likely to have a college/university education and to have been aged 35 years or older when the child was born”. Although this study does not go into extreme detail on what the demographic type questions reveal from the study, they do address a couple areas. I think that these kinds of questions could be extremely useful in the future for figuring out other possible reasons for the diagnosis of ALL in children.

Breastfeeding Benefits

As many are aware there are multiple benefits when it comes to breastfeeding over formula feeding not only for the baby but for the mother as well. “Cognitive development is improved by breastfeeding, and infants who are breastfed and mothers who breastfeed have lower rates of obesity” (Binns, 2016). This article also goes into detail of the many other reasons why breastfeeding should be the first choice and new mother makes when it comes to deciding between which kind of milk to feed your child. “Other chronic diseases that are reduced by breastfeeding include diabetes (both type 1 and type 2), obesity, hypertension, cardiovascular disease, hyperlipidemia, and some types of cancer” (Binns, 2016). Another study states, “Breastfeeding initiation rates increased among mothers aged 25–34 years, who were married, used Medicaid for delivery, and with male and older infants. Exclusive breastfeeding rates increased among married mothers and male infants” (Salm Ward, 2018). This shows some of the demographics that take part in breastfeeding choices, however I think the overall benefits of breastfeeding are the ultimate reasons mothers choose this. 

According to Womenshealth.gov there are numerous benefits to breastfeeding. “The cells, hormones, and antibodies in breastmilk help protect babies from illness. This protection is unique and changes every day to meet your baby’s growing needs” (“Making the decision to breastfeed”, 2019). The website also states that breastfed babies also have a lower risk of developing illnesses such as asthma, obesity, ear infections, and so on (“Making the decision to breastfeed”, 2019). There is a significant cost difference when it comes to formula feeding, because of the fact that breast milk has no cost as long as you are the one providing. Formula can also be much harder for an infant to digest because of different additives that are mixed in with it, which is another reason why breast milk may be the better option for your newborn. 

Recap

Overall, physicians should be educating expecting and new mothers on the different reasons why breastmilk is the more desirable source of nutrition for an infant. There are multiple studies that support the question of whether or not formula feeding an infant has any role in the diagnosis of childhood leukemia. Aside from the many different factors that partake in this such as age of the mother, ethnicity, and gender of the baby and so on, it is apparent that my original assumption is valid. Breastfeeding your infant has notably more advantages over formula feeding. This review has gone into detail in providing numerous statistical results from reliable sources to prove how childhood leukemia is linked to infants being formula fed. 

Stetler Model

Using the Stetler Model can be extremely beneficial for physicians and other nursing professions to help promote the importance of breastfeeding. This model will be an aid in planning and implementing evidence based practice into the education for patients. “The model links research use, as a first step, with evidence-informed practice. The Stetler model provides a way to think about the relationship between research use and evidence-informed practice” (Stetler Model, 2019). The five phases of this model include; preparation, validation, decision making, application and evaluation. Applying these five phases to this research proposal can be quite simple as long as they are followed through to the end.

Applying Stetler Model

Starting off with the first phase preparation, we will recognize the need for this study to be implemented, as well as addressing that the use of evidence will be useful in identifying measurable outcomes that will be useful for the evaluation phase. The validation phase involves making sure that we are using credible, and useful data and supporting evidence to help back up the research question. This step will also aid in the finding areas of other studies that could be revised to ensure adequate results. Next, the decision making phase is extremely important in that this is where the researcher will make the decision of whether or not they have all the tools and evidence to continue moving further with the study. The decision maker may feel that there is not enough data to support the hypothesis and decide to continue researching so that they have the best evidence to apply into practice. The application phase is where the researcher will, “Write generalizations that logically take research findings and form action terms (using the summary statements from Phase II/III)” (Stetler Model, 2019). This final evaluation phase is essential in completing a research project using the Stetler Model. This step will, “Clarify expected outcomes relative to the purpose of seeking evidence and whether the evaluation is related to a direct use or consider use decision” (Stetler Model, 2019). Along with this, the discussion of cost should also be considered. 

Funding

Including funding recommendations into this proposal should be a necessary consideration. Many research projects benefit from outside funding to help with finding the necessary tools and resources to use throughout the process of conducting a study. In this proposal we are talking about how formula feeding may increase an infants’ likelihood of developing childhood leukemia. That being said, I think there are many different organizations that would be willing to contribute to this kind of research to help promote breastfeeding in clinical locations. The US Breastfeeding Committees’ website has a list of over twenty organizations that all support breastfeeding. Some of the more recognized organizations include: American Public Health Association, Baby Café USA, the CDC (Center for Disease Control and Prevention and many others (USBC, 2019). Reaching out to some of these organizations can be a great tool for researchers to get funding to support this hypothesis and hopefully overall make a difference in the breastfeeding awareness community. 

Discussion

This proposal has many different areas that go into detail of the advantages and disadvantages of why choosing to breastfeed over formula feed a newborn is beneficial for not only the baby but the mother as well. There are different steps that need to be taken to follow through with this kind of research study. Starting from the beginning, the problem at hand is whether or not formula feeding an infant for any given amount of time puts them at higher risk for developing childhood leukemia. After reviewing the literature above, it is clear from previous studies how formula feeding can play a role in this disease. With that being said, diving further into these studies already done, we can pick apart different areas that could have been stronger to help support our hypothesis. 

Incorporating variables such age of the mother during pregnancy, ethnicity, duration of feeding, and brands of formula fed, etc., can help pick weave out other contributing factors to the diagnosis of leukemia. Factoring in these different variables into the study will help determine whether the hypothesis is supported or not. Furthermore, this study will need to be done in a manner that none of the participants are put in harm’s way. Using tools and resources such as surveys or questionnaires is the best approach for this. Also, making sure that the parents as well as children are completely aware of every aspect of the study and have the right to drop out at any given point if they desire. This is extremely important to ensure there are no HIPPA violations and all participants are protected as well as having full disclosure of the study. After all of the data is collected and the researchers feel they have enough information to draw conclusions, the participants will be made aware that the study is over. Analysis of this data will further be concluded. 

Conclusion

Tying together everything we have talked about in this proposal, the end means is simply to answer our original question of: In newborns, how does ever breastfeeding compared to formula feeding affect chances of childhood Leukemia? The purpose of this proposal is for future research which is why we discussed all of the factors that would be going into such study. Not only will this study need to incorporate evidence based practices, and credible resources to back the hypothesis up, but it needs to be done in such a way that the data collected will actually help determine whether or not formula feeding plays a role in the chances of developing leukemia. Applying the Stetler Model can be a great tool to help organize all of the different phases and steps to this study. Furthermore, this will aid in increasing the awareness that needs to be talked about more between physicians and expecting mothers. This proposal is a great way to shed light into the anti-breastfeeding community by giving statistical evidence that proves why formula feeding a child can lead to more complications as well as diseases or illnesses such as childhood leukemia. 

References

Amitay, E. L. (2015, June 1). Breastfeeding and Childhood Leukemia Incidence. Retrieved from https://jamanetwork.com/journals/jamapefiatrics/articles-abstract/2299705.

Appleton, J., Laws, R., Russell, C. G., Fowler, C., Campbell, K. J., & Denney-Wilson, E. (2018). Infant formula feeding practices and the role of advice and support: an exploratory qualitative study. BMC pediatrics, 18(1), 12. doi:10.1186/s12887-017-0977-7

Binns, C., Lee, M., & Low, W. Y. (2016). The Long-Term Public Health Benefits of Breastfeeding. Asia Pacific Journal of Public Health, 28(1), 7-14. https://doi.org/10.1177/1010539515624964

Breastfeeding Benefits Your Baby's Immune System. (2019). Retrieved 10 September 2019, from https://www.healthychildren.org/English/ages-stages/baby/breastfeeding/Pages/Breastfeeding-Benefits-Your-Babys-Immune-System.aspx

Evidence Based Support For Breastfeeding. (2015). Retrieved from https://www.contemporarypediatrics.com/contemporary-pediatrics/news/evidence-based-support-breastfeeding?page=0,1

Frequently Asked Questions (FAQs) | Breastfeeding | CDC. (2019). Retrieved 12 September 2019, from https://www.cdc.gov/breastfeeding/faq/index.htm

Greenberg, B., Christian, J., Henry, L., Leavy, M., & Moore, H. (2018). Ethical and Regulatory Considerations. Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK493627/

Greenop, K. R., Bailey, H. D., Miller, M., Scott, R. J., Ashton, L. J., … Milne, E. (2015).  Breestfeeding and Nutrition to 2 Years of Age and Risk of Childhood Acute Lymphoblastic Leukemia and Brain Tumors. Nutrition & Cancer, 67(3), 431-441.

https://jamanetwork.com/journals/jamapefiatrics/articles-abstract/2299705.

Informed Consent. (2019). Retrieved from https://research.uncc.edu/departments/office-research-compliance-orc/human-subjects/informed-consent

Kendall, S., M.B.E. (2019). BREASTFEEDING: THE RIGHT SUPPORT: THE JOURNAL OF THE HEALTH VISITORS' ASSOCIATION. Community Practitioner, 92(6), 48-50. Retrieved from https://prx-herzing.lirn.net/login?url=https://search.proquest.com/docview/2249721819?accountid=167104

Lingappa, A., Kalapalar, S., Rudrappa, S., & Manjunatha, S. (2018). Breastfeeding and its associated risk in children with acute leukemia: A retrospective study. Indian Journal of Medical and Paediatric Oncology, 39(3), 312-315. doi:http://dx.doi.org/10.4103/ijmpo.ijmpo_18_17

Making the decision to breastfeed. (2019). Retrieved from https://www.womenshealth.gov/breastfeeding/making-decision-breastfeed

Office for Human Research Protections, & Ohrp. (2018, January 15). Read the Belmont Report. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html#xrespect

Salm Ward, T. C., Kanu, F. A., & Anderson, A. K. (2018). Trends and Factors Associated with Breastfeeding and Infant Sleep Practices in Georgia. Journal of Community Health, 43(3), 496–507. https://doi.org/10.1007/s10900-017-0442-4

Schraw, J. M., Dong, Y. Q., Okcu, M. F., Scheurer, M. E., & Forman, M. R. (2014). Do longer formula feeding and later introduction of solids increase risk for pediatric acute lymphoblastic leukemia? Cancer Causes & Control, 25(1), 73-80. doi:http://dx.doi.org/10.1007/s10552-013-0309-7

Stetler model of evidence-based practice | Resource Details | National Collaborating Centre for Methods and Tools. (2019). Retrieved from https://www.nccmt.ca/knowledge-repositories/search/83

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USBC : Action 4: Community Organizations. (2019). Retrieved from http://www.usbreastfeeding.org/p/cm/ld/fid=96