highlights from the 18th annual national neonatal nurse - fannp

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December 2007 Vol. 18, No. 4 The Publication of the Florida Association of Neonatal Nurse Practitioners FANNP NEWS See “Symposium” on page 6 HIGHLIGHTED: REPORT FROM FANNP’S 18TH ANNUAL SYMPOSIUM • FANNP AWARDS $35,000 IN SCHOLARSHIPS • REVIEW OF CO- BEDDING PREMATURE MULTIPLE GESTATION INFANTS PLUS: POCKET NOTEBOOK • LEGISLATIVE UPDATE • EDUCATIONAL OFFERINGS Highlights from the 18th Annual National Neonatal Nurse Practitioner Clinical Symposium: Clinical Update and Review Jacqui Hoffman, MS, ARNP, RNC is year, 256 attended the 18th Annual National Neonatal Nurse Practitioner Clinical Symposium presented by FANNP. FANNP remains a dedicated organization to the professional development and practice of neonatal nurse practitioners (NNP). Registration remained high with attendants coming from throughout the continental United States, Canada, United Kingdom and even the Netherlands. Our theme for the past several years remains, “Go Learn,” “Go Network,” and “Go Relax.” In this newsletter, I’ll focus on the “Go Learn” theme. e Symposium, held last October 2007, offered the two favorite options: e review track, geared to prepare the novice NNP or student for the National Certification Corporation (NCC) Neonatal Nursing Specialties examination, and the advanced track, offering clinical and professional topics geared towards the seasoned NNP. e Symposium offered 18 speakers for the general conference and four panelists for the Round Table Dinner Discussion. e speakers presented 34 clinical and professional topics. ey represented a variety of backgrounds including Neonatal Nurse Practitioners and Neonatologists. Faculty represented several Academic Neonatal Programs, two neonatal dieticians and a pediatric pathologist. Back by popular demand at the 2007 Symposium were Dr. Carol Botwinski, Dr. Bruce Buehler, Madge Buus-Frank, Dr. Calhoun, Dianne Charsha, Leslie Parker, Dr. James Moore and Caroline Steele. New guest lecturers included Dr. Robin Bissinger, Susan Carlson, Deborah Fulop, Lisa Glantz-Williamson, Jacqui Hoffman, Dr. Carole Kenner, Denise Maguire, Terri Marin, Dr. Edwina Popek, Dr. Matthew Saxonhouse, and Dr. Joel Stenzel. Speakers at the 2005 Symposium: Top, Dr. Darlene Calhoun; lower left, Terri Marin; lower right, Dr. Joel Stenzel.

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December 2007 Vol. 18, No. 4

The Publication of the Florida Association of Neonatal Nurse Practitioners

FANNPNEWS

See “Symposium” on page 6

HIGHLIGHTED: REPORT FROM FANNP’S 18TH ANNUAL SYMPOSIUM • FANNP AWARDS $35,000 IN SCHOLARSHIPS • REVIEW OF CO-BEDDING PREMATURE MULTIPLE GESTATION INFANTS

PLUS: POCKET NOTEBOOK • LEGISLATIVE UPDATE • EDUCATIONAL OFFERINGS

Highlights from the 18th Annual National Neonatal Nurse Practitioner Clinical Symposium:

Clinical Update and ReviewJacqui Hoffman, MS, ARNP, RNC

This year, 256 attended the 18th Annual National Neonatal Nurse Practitioner Clinical Symposium presented by FANNP. FANNP remains a dedicated organization to the professional development and practice of neonatal nurse practitioners (NNP). Registration remained high with attendants coming from throughout the continental United States, Canada, United Kingdom and even the Netherlands. Our theme for the past several years remains, “Go Learn,” “Go Network,” and “Go Relax.”

In this newsletter, I’ll focus on the “Go Learn” theme. The Symposium, held last October 2007, offered the two favorite options:

The review track, geared to prepare the novice NNP or student for the National Certification Corporation (NCC) Neonatal Nursing Specialties examination, and the advanced track, offering clinical and professional topics geared towards the seasoned NNP.

The Symposium offered 18 speakers for the general conference and four panelists for the Round Table Dinner Discussion. The speakers presented 34 clinical and professional topics. They represented a variety of backgrounds including Neonatal Nurse Practitioners and Neonatologists. Faculty represented several Academic Neonatal Programs, two neonatal dieticians and a pediatric pathologist.

Back by popular demand at the 2007 Symposium

were Dr. Carol Botwinski, Dr. Bruce Buehler, Madge Buus-Frank, Dr. Calhoun, Dianne Charsha, Leslie Parker, Dr. James Moore and Caroline Steele. New guest lecturers included Dr. Robin Bissinger, Susan Carlson, Deborah Fulop, Lisa Glantz-Williamson, Jacqui Hoffman, Dr. Carole Kenner, Denise Maguire, Terri Marin, Dr. Edwina Popek, Dr. Matthew Saxonhouse, and Dr. Joel Stenzel.

Speakers at the 2005 Symposium: Top, Dr. Darlene Calhoun; lower left, Terri Marin; lower right, Dr. Joel Stenzel.

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THE FLORIDA ASSOCIATION OFNEONATAL NURSE PRACTITIONERS

BOARD OF DIRECTORS

Carol Botwinski, Largo, FLPresident

Jacqui Hoffman, Seminole, FLPresident Elect

Deborah Fulop, Jacksonville, FLPast President

Kim Irvine, Land O’Lakes, FLSecretary

Karen Theobald, St. Petersburg, FLTreasurer

MEMBERS AT LARGE

Terri Marin, Peachtree City, GALeslie Parker, Gainesville, FLDiana Fuchs, Rockledge, FL

Genieveve Cline, Clearwater, FL

Genieveve ClineNewsletter Editor

1-800-74-FANNP • www.FANNP.orgP.O. Box 14572, St. Petersburg, FL 33733-4572

Legislative UpdateFall, 2007

Leslie Parker, RNC, NNP MSN

The 2007 Florida legislative session proved to be exciting, productive and filled with a number of important issues effecting advanced practice nursing. Bills passed during this session included the following; 1) title protection for Certified Registered Nurse Anesthetists, Certified Nurse Midwives, and Clinical Nurse Specialists and 2) inclusion of ARNPs and PAs in the statue which provides certain civil immunity to health care providers who obtain informed consent. Unfortunately the bill allowing ARNPs to certify the cause of death and sign death certificates and the prescriptive privilege bill which would allow ARNPs to prescribe controlled substances did not pass.

The Florida legislation is gearing up to begin its next session in March of 2008. The Florida Nurses Association is busy preparing to make 2008 a productive session with a positive outcome for nurses and advanced practice nurses in the state of Florida.

On a national level, the American Nurses Association Political Action Committee (ANA-PAC) endorses candidates who show support for the nursing profession. The last election in November, 2006 represented the highest percentage of elections for candidates endorsed by ANA-PAC with

a win rate of 89%. Please consider supporting representatives that support our profession. To find out who they are, please refer to the ANA web site at http://www.nursingworld.org/MainMenuCategories/ANAPoliticalPower/ANAPAC.aspx

To increase awareness of the issues concerning the nursing profession including the severe nursing shortage, Representatives Lois Capps (D-CA) and Steven LaTourette (R-OH) have established a bi-partisan Congressional Nursing Caucus. This caucus will allow open forums to address nursing issues, serve as a clearinghouse for information and provide a sounding board for issues brought to congress related to nursing. It is anticipated that this caucus will greatly benefit all nurses.

In October 2007, President Bush unfortunately vetoed continuing support for the State Children’s Health Insurance Program (S-CHIP). ANA will continue to work with congress to improve the health care for disadvantaged children in this nation.

Due to the large number of nurses in America, we have the opportunity to make huge changes in the current health care system. However, this will only occur when nurses become involved in political issues. It is our duty as ARNPs to become familiar with the issues concerning our profession and to become active in our national and state organizations.

LegislativeUpdate

Congratulations to Ruth Bartelson, ARNP, recipient of the 2007

Kim Nolan Spirit Award!

(See Spring newsletter for more information.)

Continues on page 4

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ABSTRACT

Objective: To examine current research concerning the benefits and safety of co-bedding by acquiring all available published studies involving the co-bedding of premature multiple gestation infants verses single bedding, and then to provide the best evidence available concerning co-bedding.

Design and Methods: A systematic integrative review of the literature was conducted using the following databases: MEDLINE, Cumulated Index of Nursing and Allied Health Literature (CINAHL), PubMed and the Cochrane Database of Systematic Reviews (CDSR). Search word used was “co-bedding.”

Results: The search of the four databases revealed a total of seven papers that met the inclusion criteria for research studies concerning the co-bedding of premature multiple gestation infants.

Conclusions: The theory of co-bedding as a developmental intervention sounds good in theory, but this intervention has not been substantiated by a rigorous review of the literature. The National Association of Neonatal Nurses (NANN) states that “existing scientific data are insufficient to either support or refute implementation of the practice of co-bedding twins or higher order multiples…it is the position of NANN that co-bedding cannot be endorsed until further research is available” (National Association of Neonatal Nurses, 2006).

Key Words: co-bedding, premature, multiple gestation.

Co-bedding is the practice of placing multiple birth infants together in the same radiant warmer bed, incubator or bassinet. It was first reported in the 1940’s and has

An Integrative Review of Co-bedding Premature Multiple Gestation Infants

Michelle C Howe

been used frequently in countries with limited health resources as an intervention for multiples. In the United States this practice has been limited (Hudson-Barr, 2003; Lutes, 1996). Interest in co-bedding increased in the United States in 1995 after a story was published about twin girls at a Massachusetts Hospital whose health status improved after being co-bedded (Hudson-Barr, 2003; Lutes, 1996; Taylor and LaMar, 2006).

Neonatal nurses are caring for an increased number of premature multiple low birth weight infants. Infertility treatment has contributed to the increased multiple birth rates of which most are premature (Chin, Hope and Christos 2006; Taylor and LaMar, 2006). In 2002, the national twin birth rate was 31.1 twins per 1,000 live births with 60.1 percent of multiple gestations being born before 37 weeks gestation, and 57.6 percent of multiples being low birth weight infants (Taylor and LaMar, 2006). The NICU is a fast paced, highly technical environment in which neonatal nurses are striving to provide family-centered, developmental care to their patients of which an increasing number are multiples. This has led to the increased usage of co-bedding within NICUs.

The proposed benefits of co-bedding are based on the theory of co-regulation. Co-regulation is the theory that twins have “a special capacity for supporting each other because of their common uterine experiences” (Nyqvist and Lutes, 1998). It is felt that co-bedding will assist co-regulation in extrauterine life and improve physiologic regulation of each infant (Nyqvist and Lutes, 1998; Lutes, 1996), along with improved rate of growth and development, decreased cardio respiratory events, improved sleep-

wake cycles, and a decrease in the twins’ need for ambient temperature support (Taylor and LaMar, 2006). Boyd argues that co-bedding will increase parent-infant attachment, improve parent-nurse communication, and decrease length of stay (Hudson-Barr, 2003). Other benefits theorized are decreased length of hospital stay, lower hospital costs, and a reduction in the number of readmissions; since co-bedded infants are cared for by a single nurse on each shift, there is increased consistency and improved communication with parents which results in enhanced preparation for discharge (Lutes, 1996).

Along with these proposed benefits many risks have also been identified concerning co-bedding. These include “infection, hypo/hyperthermia, disturbance of sleep/wake cycles, dislodging of feeding tubes, entanglements in equipment wiring and physical harm from close physical contact” (Chin, Hope and Christos, 2006). In addition, the possibility of increased risk of sudden infant death syndrome (SIDS) is of grave concern (Hayward, 2003). Co-bedding recommends a side lying face-to-face positioning of infants. A side lying position is in direct conflict with the AAP “Back to Sleep” campaign (Taylor and LaMar, 2006). Re-breathing and hyperthermia are also thought to be precursors to SIDS; with face-to face positioning re-breathing could be a concern and co-bedded infants are reported to have higher body temperatures (Hayward, 2003).

Co-bedding was introduced as a developmental intervention in the NICU based purely on theory and anecdotal information; no randomized, controlled trials were undertaken (Chin, Hope and Christos, 2006; Taylor and LaMar, 2006), and now years later only a few studies have been conducted to assess the benefits and safety of co-bedding.

PURPOSEThe purpose of this integrative review

is to seek out current research concerning

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the benefits and safety of co-bedding by acquiring all available published studies involving the co-bedding of premature multiple gestation infants verses single bedding. It is the hope of the author to provide the best evidence available concerning the benefits and safety of co-bedding premature multiple gestation infants.

METHODS

DesignA systematic literature review was

conducted that focused on all published studies addressing the co-bedding of premature multiple gestation infants. Initially it was the author’s intent to look only at randomized controlled trials, but due to the limited number of studies concerning co-bedding all quantitative and qualitative studies were included in the review. Excluded from review were opinion articles, letters to the editor and single case reports, since they fall within the lowest levels of the hierarchy of evidence (Melnyk and Fineout-Overholt, 2005, p.10).

SampleThe population examined was preterm

multiple gestation infants less than 37 weeks gestation. The infants studied were not being mechanically ventilated, nor did they have arterial lines or chest tubes and lacked signs and symptoms of sepsis. All studies were conducted while the infants were hospitalized and being monitored.

Search strategy and resultsThe search strategy included electronic

databases and from those articles obtained from the database search an ancestry approach was utilized. Only those databases assessable to the author were used. Four databases were searched: MEDLINE, Cumulated Index of Nursing and Allied Health Literature (CINAHL), PubMed and the Cochrane Database of Systematic Reviews (CDSR). The search in MEDLINE explored literature from 1950 to week two of March 2007. The keyword used for the search was

“cobedding;” no limit was used. The search revealed 11 citations.

The CINAHL database was also explored. This review tracked publications between 1982 and week three of March 2007. The subject heading was “co-bedding;” no limits were used. Using this search strategy, 14 citations were noted.

The PubMed database was also searched. This database was investigated using the same search word of “co-bedding”. Eleven citations resulted.

The CDSR database was investigated using “co-bedding” and “bed sharing” as keywords; no matches were found using either keyword.

The computerized literature search of the above databases resulted in a large overlap of citations; thus, an ancestry approach was employed in an attempt to obtain further research reports. The extended search was conducted using the reference list of the published articles obtained from three of the above databases: MEDLINE, CINAHL and PubMed. No attempts were made to seek out unpublished works.

One article was not located due to incomplete or inaccurate reference material. Four other studies were not available to the author due to lack of journal access. Only brief reference is made to these studies in other papers, three addressed the rate of infection and one looked at weight gain in co-bedded infants.

Data extraction and analysisEach article was read and the

appropriate information was entered on a code sheet (see attached code sheet). The code sheet was used to organize the articles. Many articles on co-bedding were obtained but few were actual studies. Numerous opinion articles, letters to the editor and individual case reports in which the author would draw conclusions from their experiences were retrieved. All studies meeting the inclusion criteria are discussed in the integrative review; none were excluded in ordered to limit

researcher bias. The main threat to internal validity in the studies that were reviewed was selection as most studies were not randomized (Polit and Beck, 2004, p.214). Threats to external validity noted were expectancy, novelty and experimenter effects (Polit and Beck, 2004, p.218-219).

RESULTSThe search of the four databases

revealed a total of seven papers that met the inclusion criteria for research studies concerning the co-bedding of premature multiple gestation infants. Each study is discussed briefly; they are listed in chronological order. See Table 1 for summary of co-bedding research studies.

Nyqvist and Lutes (1998) conducted a qualitative study of mother’s perceptions of their preterm twins’ co-bedding experience to investigate how preterm twins respond to co-bedding. The information was obtained through structured interviews with the mothers; although the study had a small sample size valuable information was obtained from this early qualitative project on co-bedding. Mothers reported infants showed a variety of movements directed at each other and that infants seemed restless when separated, and they seemed to prefer a face-to-face position. Mothers noticed differences in sleep/wake states, with co-bedded infants waking up together and calming down and falling asleep more easily when together. Observational data suggested that co-bedded infants may require a lower environmental temperature.

Touch and associates found that the number of apneic events decreased after co-bedding was initiated. The etiology for this was unclear. They attributed it to a possible change in sleep pattern due to more frequent arousal by the alternate twin, or it may reflect a positive physiological response to contact between the twins. No adverse events were noted although they did report extensive in-servicing of staff on co-bedding to ensure

CO-BEDDING REVIEW continued

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safety. Strength in this study was the blinded investigator evaluating monitor-recorded events to document apnea episodes thus avoiding subjectivity of caregiver. Limitation was the small sample size (Touch, Epstein, Phol and Greenspan, 2002).

In the study conducted by Byers and colleagues their results did not support the physiological benefits purposed but their results did support the idea that co-bedding is a safe practice. There was no increased incidence of infection in the co-bedded group. Parents of the control group had increased anxiety and decreased maternal attachment over time, unlike the co-bedded group. There was no formalized developmental care program in place in the NICU in which the study was conducted. Limitations to their study were a small sample size and an inexperienced staff in regards to caring for co-bedded infants (Byers, Yovaish, Lowman and Francis, 2003).

LaMar and Dowling (2006) found no increased incidence of infection in co-bedded infants. Limitations to this study were lack of randomization and the retrospective design. Strengths of this study were the large sample size.

Chin and associates showed a greater increase in weight gain in co-bedded group compared to the control group. Their study did not show a difference in the incidence of apnea in the two groups. The previous study looking at apnea collected data with a blinded investigator evaluating monitor-recorded events whereas Chins group relied on the nurse caring for the infant to record apnea episodes. Limitations to the study are its small sample size and possible caregiver bias due to lack of double blind design. Also, caloric intake was not controlled for, which may explain the differences in weight gain (Chin, Hope and Christos, 2006).

Taylor and LaMar discuss the process of implementing co-bedding in the NICU at the University of Michigan. This was done after they conducted a prospective

study to examine the incidence of infection in ten sets of co-bedded twins before, during, and after co-bedding. They did not find an increase in infection rates nor did they find any adverse events associated with co-bedding. Given this was a pilot study, the small sample size is a limitation that must be considered when interpreting results (Taylor and LaMar, 2006).

Hayward’s group conducted a randomized pilot study on co-bedding in which the results were used “to determine the estimated effect size, determine staff and bedside care organization, evaluate feasibility of data collection measures, and identify issues related to recruitment and follow-up” for a larger multi-centered trial grant proposal. The proposed multi-center trial looking at co-bedding has received provincial funding at the time the pilot study was published (Hayward, Campbell-Yeo, Price, Morrison, Whyte, Cake, et al., 2007).

CONCLUSIONSA review of the literature does not

support the proposed benefits of co-bedding. Most of the studies reviewed had small sample sizes and the findings were not consistent between studies. Some of the risk concerns have been addressed. Several studies addressed the incidence of infection and found none with co-bedded infants. The concern for an increased risk of infection with co-bedded infants does not seem to exist. Also, with extensive in-servicing of staff no medication errors were reported in any of the studies. No study addressed the concern for an increased incidence of SIDS with co-bedding. No study looked at long-term follow up. The idea of co-bedding as a developmental intervention sounds good in theory, but this intervention has not been substantiated by a rigorous review of the literature. The National Association of Neonatal Nurses (NANN) supports the findings of this integrative review. NANN states that “existing scientific data are insufficient to either support or

refute implementation of the practice of co-bedding twins or higher order multiples…it is the position of NANN that co-bedding cannot be endorsed until further research is available” (National Association of Neonatal Nurses, 2006).

DISCUSSIONStudies on co-bedding continue

to emerge in nursing literature. The first evidenced-based clinical practice guidelines on co-bedding should be forth coming from the proposed multi-center trial by Hayward and associates.

All the papers reviewed looked at premature infants while hospitalized; no studies were available that looked at healthy term infants or the practice of co-bedding once the infant is discharged home and not being monitored. Further studies are needed to address the transition to home and the practice of co- bedding. Also, the concern of SIDS and co-bedding must be investigated further. Long-term follow-up studies to confirm proposed developmental benefits of co-bedding are also needed.

Finally, each unit must have established criteria for implementing the practice of co-bedding and a written protocol to follow. Extensive in-servicing of staff on co-bedding is paramount before implementing this intervention.

REFERENCES

Byers, J., Yovaish, W., Lowman, L., & Francis, J. (2003) Co-bedding versus single-bedding premature multiple-gestation infants in incubators. Journal of Obstetric, Gynecologic, and Neonatal Nursing, 32, 340-347.

Chin, S., Hope, L., & Christos, P. (2006) Randomized controlled trial evaluating the effects of cobedding on weight gain and physiologic regulation in preterm twins in the NICU. Advances in Neonatal Care, 6(3), 142-149.

Hayward, K., Campbell-Yeo, M., Price, S., Morrison, D., Whyte, R., Cake, H., et al. (2007) Co-bedding twins: How

Continues on page 6

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pilot study findings guided improvements in planning a larger multicenter trial. Nursing Research, 56 (2), 137-143.

Hayward, K. (2003) Cobedding of twins: A natural extension of the socialization process? American Journal of Maternal Child Nursing, 28(4), 260-263.

Hudson-Barr, D. (2003) Should nurses promote cobedding of multiples? Pro. The American Journal of Maternal Child Nursing, 28(6), 348.

LaMar, K. & Dowling, D. (2006) Incidence of infection for preterm twins cared for in cobedding in the neonatal intensive-care unit. Journal of Obstetric, Gynecologic, and Neonatal Nursing, 35(2), 193-198.

Lutes, L. (1996) Bedding twins/multiples together. Neonatal Network, 15(7), 61-62.

Melnyk, B. & Fineout-Overholt, E. (2005). Evidenced-based practice in nursing & healthcare. Philadelphia: Lippincott Williams & Wilkins.

National Association of Neonatal Nurses. (2006) Co-bedding of twins or higher order multiples. Retrieved March 21, 2007, from http://www.nann.org/files/public/co-beddingposition.pdf.

Nyqvist, K., & Lutes, L. (1998). Co-bedding twins: A developmentally supportive care strategy. Journal of Obstetric, Gynecologic, & Neonatal Nursing, 27(4), 450-456.

Polit, D., & Beck, C. (2004). Nursing research: Principles and methods. Philadelphia: Lippincott Williams & Wilkins.

Taylor, C., & LaMar, K. (2006). Cobedding in the NICU: A new adventure. Neonatal Network, 25(6), 413-418.

Touch, S., Epstein, M., Pohl, C., & Greenspan, J. (2002) The impact of cobedding on sleep patterns in preterm twins. Clinical Pediatrics, 41(6), 425-431.

Many of the NNP Programs highly recommend attendance at the conference by their students. We have received feedback over the past several years from attendants in the review track that felt a large part of their success on the NCC certification exam was due to the review track helping them target their studying. Students get a chance through the many networking opportunities, including the Round Table Dinner discussion on Role Transition, to share their fears and concerns with other students in different programs and receive pointers on lessons learned from other students as well as seasoned NNPs. The informal discussions that occur throughout the

week among new and seasoned NNPs regarding clinical situations they have encountered or finding out how “other” practices manage different clinical and professional situation is priceless and offers many potential resources.

FANNP would like to thank all of the speakers and participants who attended the 2007 Symposium and hope to see many of you back in 2008. We have many guest speakers returning at your request, new guest speakers and exciting topics that are sure to meet your needs whether you are a student preparing for NCC Certification or a seasoned NNP wanting to get new information. Watch for your brochure to come in the mail in May or check out our website at fannp.org. See you soon.

Speakers at the 2005 Symposium: Pictured clockwise, Deborah Fulop and Lisa Glantz-Williamson, Dianne Charsha, Jacqui Hoffman, Dr. Matthew Saxonhouse and Leslie Parker.

CO-BEDDING REVIEW continued

SYMPOSIUM continued from page 1

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In order to advance the care and treatment of neonates in the neonatal intensive care, research will be required; however the protection of human subjects in research must always take precedence over the advancement of science. The protection of human subjects in biomedical research is the primary responsibility of the National Institute of Health (NIH) and its sub-branch the Office for Human Research Protections (OHRP), along with the Institutional Review Board (IRB), and must be the individual responsibility of every individual ethical researcher. To protect human subjects in biomedical research the Belmont Report (1979) outlines the process of informed consent which is based on the bioethical principles of autonomy, beneficence, and justice. The purpose of this paper is to explain why neonates represent a vulnerable population for research, discuss the ethical principles which are at risk of violation in this population, and outline what the research team can do to ensure the integrity of their research design when studying this defenseless population of research participants.

Neonates represents a truly vulnerable population of potential research participants because they lack competency due to their age, or the developmental and cognitive ability necessary to understand the purpose, benefits, risks, and procedures involved in a proposed research project and provide the required informed consent. In order to provide informed consent, as outlined by the guidelines established in the Belmont Report (1979), the research participant must be able to understand all aspects of what they are being asked to do, and must be free from coercion. Therefore, for all research involving neonates, the parents are required to provide informed consent after being given all necessary and relevant information, at a level they can understand, in their own native language, and free of undue influence. Title 45, Part 46 of the Code of Federal Regulations and its Sub parts A (Common Rule), B (Additional Protections for Pregnant Women, Human Fetuses and Neonates), D (Addition Protections for Children) and institutional IRB guidelines outline the requirements for informed consent, and indicate the need for special precautions to protect vulnerable populations of human subjects in biomedical research such as pregnant women, fetuses, children, physically or mentally disabled persons, and prisoners (National Institutes of Health Office of Human Subjects Research, 2005) .

The process of informed consent is basic requirement for the protection of human subjects in biomedical research and is

Neonates: A Vulnerable

Research Study Population Genieveve J. Cline, ARNP, MSN, RNC

based on the bioethical principles of autonomy, beneficence, and justice as outlined in the Belmont Report (1979). According to Pence (2004), respect for the participant’s autonomy recognizes the fundamental right of each person to make decisions about their life, medical care and treatment and to decide whether they would like to participate in a research project after they have been fully informed about the purpose, procedures, benefits, risks, alternatives, at level

they can understand, in their own native language, and free from coercion. In the case of infants this process of informed consent is delegated to the parents, or legal guardian. The principle of beneficence reminds healthcare providers that we have an obligation to recommend medical care, treatment, and research that will promote the health and well being of the patient. This means that the principle investigator must reveal all the possible alternative treatment options so the patient can make an informed decision. The principle of justice means that the participant must be treated fairly and the interventions outlined in the study must not be different from that offered to any other participant under similar circumstances. The principle of justice also means that the criterion for determining inclusion and exclusion in the study must be made fairly so that participants are enrolled in the study based on their relevance to the problem or question under study, and not just because they are readily available or vulnerable, and the population enrolled in the study must also benefit equally from the results of the study (Pence, 2004, chap. 1).

According to Diekema (2006), and National Institute of Health (NIH) (2002), to promote ethical research and the protection of human subjects in research, the researcher has a responsibility to ensure that the study is properly designed, grounded in scientific evidence, and will produce valid results. The researcher must make every attempt to minimize the potential risk to the participants and maximize the benefits. The researcher must also ensure that the study has been reviewed and approved by the IRB and all participants meet the predetermined eligibility requirements and have signed the IRB approved informed consent after full disclosure of the purpose of the study, the procedures involved, the time commitment, benefits, risks, alternatives, at a level they can understand, in their own native language, and without coercion. The participants must also have all their questions answered

Continues on page 8

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and be given a written copy explaining the research, and a phone number to reach the principle investigator and the IRB if they have any questions or concerns. They must also be informed that their participation is voluntary and even if they initially consented to participate in the study they are free to leave the study at any time. The researcher must also ensure that participant recruitment, selection, and eligibility are done fairly and according the IRB approved study protocol. The researcher is also responsible to conduct the study according to the research protocol approved by the IRB, and any proposed changes in the study must be reported and formally approved by the IRB before implementation. The researcher also has an obligation to ensure that data collection is done according to protocol, that the privacy and confidentiality of participants are maintained, and that all adverse events are reported to the IRB and appropriate authorities. In addition, the researcher is responsible for ongoing monitoring to ensure the rights and welfare of the participants is maintained throughout the study as well as to make sure that all members of the research team have completed the required human protections training and conduct themselves in an ethical manner. The researcher must conduct ethical research as outlined above in order to protect the rights of the human participants in their study and promote public trust. Maintaining ethical standards in research requires even more diligence when vulnerable populations such as neonates are involved (Diekema, 2006; NIH, 2002).

In conclusion, the protection of human subjects in biomedical research must be the responsibility of every individual ethical researcher in order to prevent atrocities that have historically occurred, such as in Nazi Germany during World War II. To protect human subjects in biomedical research the Belmont Report (1979) outlined the process of informed consent based on the bioethical principles of autonomy,

beneficence, and justice. Neonates represent a vulnerable population of research participants because they lack competency to provide informed consent, therefore a researcher conducting a study on this vulnerable population must strictly adhere to the guidelines established by the NIH (2002) and follow the research protocol as approved by the IRB in order to protect the rights of the infant participants in their study and promote the public trust.

References

Diekema, D. S. (2006). Conducting ethical research in pediatrics: A brief historical overview and review of pediatric regulations. Journal of Pediatrics, 149, S3-S11.

National Institutes of Health Office of Human Subjects Research. (2005). Title 45 CFR Part 46 Code of Federal Regulations, Retrieved June 29, 2007 from http://ohsriod.nih.gov/guidelines/45cfr46.html.

Pence, G. E. (2004). Classic cases in medical ethics: Accounts of cases that have shaped medical ethics, with philosophical, legal, and historical backgrounds ( 4th Ed.) Boston: Mc Graw Hill.

The National Commission for the Protection of Human Subjects of Biomedical Research. (1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Retrieved June 29, 2007 from http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

U.S. Department of Health and Human Services National Institutes of Health. (2002). Human participant protections education for research teams. Retrieved June 29, 2007 from http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp.

1. Which of the following cardiac defects could be described as an acyanotic lesion that results in increased recirculation of blood to the lungs, resulting in increasing CHF once pulmonary vascular resistance drops to normal post natal levels?

A. Ventricular septal defect (VSD) B. Tricuspid Atresia C. Pulmonary Atresia D. Transposition

2. Infants born to mothers with insulin-dependent diabetes mellitus are at greater risk for developing which of the following cardiac defects?

A. Endocardial cushion defect B. Ebstein’s malformation C. Hypertrophic cardiomyopathy D. Tetraolgy of Fallot

Answers on page 10

Bring it On…Practice Questions to Prepare for the NNP Certification Exam

RESEARCH continued

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#POCKET NOTEBOOKDiane McNerney ARNP, MS, RNC

Educational Offerings

8th Annual International Symposium on Congenital Heart Disease, Special Focus: Tetralogy of FallotFebruary 16-19, 2008Renaissance Vinoy Resort & Gulf ClubSt. Petersburg, FloridaJointly Sponsored by: USF Health, All Children’s Hospital, & Congenital Heart Institute of [email protected]

The National Conference of Neonatal NursingApril 1-5, 2008Las Vegas, NVContemporary Forumswww.contemporaryforms .com

5th National Advanced PracticeNeonatal Nurses ConferenceApril 24-26, 2008Hyatt Regency Miami, FloridaNeonatal Network & NANNwww.neonatalnetwork.com

Neonatal PharmacologyJune 18-21, 2008Boston, MAContemporary Forumswww.contemporaryforms .com

Perinatal DilemmasAugust 3-6, 2008Jackson Hole, WYContemporary Forumswww.contemporaryforms .com

8th National Neonatal Nurses MeetingOctober 8-11, 2008Marriot Wardman ParkWashington, DCwww.neonatalnetwork.com

Bring it On…Practice Questions to Prepare for the NNP Certification Exam

Estimate of IVH and ROP by gestational weight and age

The FANNP thanks the following companies for their generous support of its 18th National NNP Symposium…

FLAMINGO SPONSORS

Linkous & Associates

Mead Johnson Nutritionals

National Association of Neonatal Nurses (NANN)

Ovation Pharmaceuticals

Pediatrix Medical Group

Ross Pediatrics

Sophia Palmer Nurses RRG, Inc.

BLUE HERON SPONSORS

INO Therapeutics LLC

Nationwide Children’s Hospital

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Doctorate of Nursing PracticeReflections on Nursing Leadership

Diane McNerney, ARNP, MS, RNC

Knowledge utilization is an essential component of today’s nursing and healthcare systems. Such knowledge has moved beyond factors affecting the individual nurse to a broader perspective that includes the practical environment and extends into the sociopolitical arenas. Seeing the big picture is a good predictor of leadership success. The goal of the doctoral nursing leader are to improve and develop professional knowledge and learning techniques in order to conduct independent research, develop nursing theory, and to make scientific applications in domestic as well as international conferences. Nurse leaders are focused in research, education and management, improving the quality of nursing practice. As the doctorate of nursing practice masters competency in organizational problem solving of health issues from a comprehensive perspective, they will work on establishment and development of care systems as well as participating in quality health care projects. Nurse leaders are external stakeholders who play an essential role in managing change, cultural integration, directing a positive attitude toward changing healthcare structures. The challenges facing such scholars are monumental. DNP nurse leaders will assume expanded roles and responsibilities, seeing farther than others; often envisioning the future before others do. Such leaders are people who can influence a group of individuals to take direction. On the horizon are ideas to build new and more exciting nursing models and implementing strategies for building accountability. It is important to me to assure a well defined process, adhering to principles of implementation of effectiveness and comparing effective and ineffective approaches. In an advanced role, DNP nurse leader’s work in environments that promote and sustain evidence based practice in both clinical and administrative areas. Their role influences associate directors in all services of governing structures to examine performance expectations and role components for a variety of healthcare settings. Using knowledge of work design and communicating with other stakeholders, the DNP nurse leader is creative in supporting the code of professionalism. As a nurse leader, the DNP play a vital role in setting expectations and creating a culture that fosters strong working relationships between nursing support

service groups. This interdisciplinary collaboration will create a culture that promotes satisfaction and fosters high quality care delivery. The impact of the refined and advanced interventions generates organizational development programs to provide a path to create a respected work force in nursing. The nursing profession is undergoing accelerated growth and the emergence of advanced academic programs is a driving force in nursing practice and professional advancement. New education models, like the university based DNP programs, are addressing a critical need for expanding leadership capacity, performance improvements and nursing quality. Advanced nursing standards are being developed by collaborating experiences that address diversity and preparation for global thought and leadership. The nursing profession has a new future! Education, research and clinical practice needs are being recognized on newer dimension and remarkable results are being achieved. Through nursing leadership, a social blue print is developing where nursing can express itself in a new way that allows growth and advanced expression of educational talent. The Doctors of Nursing Practice are a new breed of leaders in command and control where satisfaction brings innovation and organization a bright future.

Bring it On…Answers (Questions on page 8)

1. (A) Ventricular septal defect (VSD) 2. (C) Hypertrophic cardiomyopathy

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FANNP is proud to announce over $35,000 awarded in college scholarships during the past ten years to 41 deserving candidates advancing their careers through the pursuit of advanced degrees. FANNP members from across the country including Florida, Alabama, Hawaii, North Carolina, Mississippi, Maryland, California, Tennessee, South Carolina, Iowa, Indiana and Arizona have been scholarship recipients.

Three educational scholarships were awarded at the 18th Annual FANNP Business Meeting held at the Sheraton Sand Key Resort in Clearwater Beach, Florida. The recipients all showed dedication and excellence in neonatal care.

Please join the FANNP Board of Directors in congratulating the 2007 FANNP scholarship recipients:

Pam Laferriere has been an NNP for 18 years and is currently working to complete her degree at University of South Alabama. Pam is from Ft. Myers, Florida. She has served FANNP as a Board Member and Conference Planning Committee.

Layne Petrino from Gainesville, Florida is studying to become and NNP at the University of Florida.

Leslie Parker, Clinical Assistant Professor at the University of Florida is the NNP program Director at UF. She is working full time, the mother of four, and a member of the FANNP Board of Directors and is working on her doctorate at the Medical University of South Carolina.

FANNP remains committed to promoting education for NNPs and is proud to be able to award scholarships to nurses and NNPs continuing their educational pursuits in the field of neonatal health care. Each year on Dec. 31, at least 10% of the available monies in the FANNP general operating budget are put in a scholarship fund.

The FANNP scholarship fund will have over $20,000 available in 2008. Scholarships of $500 to $1000 per qualified applicant will be awarded at the FANNP Annual Business meeting scheduled in conjunction with the FANNP National Neonatal Nurse Practitioner Symposium: Clinical Update and Review in October.

Are you eligible for a scholarship?FANNP members who attend an educational program leading to a degree related to the health care field between Sept. 15, 2007 and Sept.15, 2008 are eligible for a 2008 scholarship. See eligibility criteria below.

• Scholarship applicants must be FANNP members.

• Priority for scholarship award will be given to members, followed by student members and then associate members.

• Priority for scholarship award will be based on length of membership and service to FANNP.

• Scholarship applicants must be a licensed RN, ARNP, NNP or equivalent.

• Preference will be given to currently licensed certificate NNPs working towards a NNP degree.

• Scholarship applicants must attend an educational program leading to a degree related to the health care field during the application period.

• The application period for the 2008 scholarship is Sept. 15, 2007 to Sept. 15, 2008. (i.e. Applicants must have attended classes sometime between Sept. 15, 2007 and Sept. 15, 2008.)

• An applicant may receive a maximum of two scholarship awards for each degree sought.

• Preference will be given to those working towards a degree in neonatal health care.

• If awarded a scholarship, recipients agree to write a short article for the FANNP newsletter within the next year.

• The Completed scholarship application must be Postmarked by Sept. 15, 2008.

FANNP Awards Over $35,000 in

College Scholarships

FANNPP.O. Box 14572St. Petersburg, FL 33733-4572

The information in this newsletter is protected by copyright and may not be copied or transmitted without permission of the publisher. The information contained reflects the opinions of the authors and not necessarily those of the FANNP. While every effort is made to validate the information presented, FANNP makes no absolute guarantees as to the accuracy of the information within.

Welcome to the first edition of “Penelope’s Pose.” My goal is to bring new pearls of research strung with old beads of understanding and knowledge. I hope that the FANNP membership will submit questions and suggestions of topics to investigate.

Our world is changing. What dichotomy and synchrony is expressed in the statement: Change is constant. Do we face inevitable change with drudgery and angst? Or, do we embrace it and allow it to promote us to the next level?

Penelope’sPose

A positive way to embrace change is with appreciative inquiry (AI). The foundation of AI is built on the 4 Ds: discovery, dream, design, and destiny (Cooperrider, Whitney, & Stavros, 2005). AI emphasizes: (a) discovering what is right with who we are and what we do; (b) dreaming about how we might improve on how we act by what we know; (c) design a better way; and (d) perpetuating the new design to realize our destiny (Thomas, 2007).

AI can be used to facilitate the application of evidence-based research to the development of best practice. I would like to share with you a few of my own tenets as described in Penelope’s Pentameter of Research Application: passionate, positive, purposeful, prudent,

and prolific. Application of research to practice should be something that we can be passionate about! Evidence-based practice has a purpose about which we can be positive! We need to embrace change; however, prudence is a virtue. Best-care practices are prolific, for the profession and the populations for whom we care.

Until next time — Penelope Nerdski

Cooperrider, D., Whitney, D., and Stavros, J. (2005). Appreciative inquiry handbook. San Francisco, CA: Berrett-Koehler.

Thomas, E. C. (2007). Appreciative inquiry: A positive approach to change. Retrieved November 8, 2007, from http://www.lpspr.sc.edu/ejournal/ejournal0611/Appreciative20%Inquiry.pdf