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Effect of Prenatal Lactation Education on Lactation Success in Mothers at Risk of Preterm Delivery

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Effect of Prenatal Lactation Education on Lactation Success in Mothers at Risk of Preterm Delivery
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Richburg, Morgan Leigh
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Background: Mothers of preterm infants often produce insufficient amounts of breast milk (BM). Early initiation of BM expression following delivery is associated with increased lactation success, but lack of nursing time delays BM expression in this population. Purpose: To determine if providing antenatal breast expression education to the support person (SP) of mothers at risk of preterm delivery improves lactation success. Methods: Twenty women at risk for delivering a preterm infant and their SP were randomized into two groups. Mothers and their SP in Group 1 received education regarding how to use a breast pump and a breast pump was placed into their hospital room. Group 2 received standard care. Data regarding BM volume produced, time to initiation of BM expression and time to onset of lactogenesis stage II was collected. Results: While there was no difference in time to onset of lactogenesis stage II, mothers in Group 1 initiated BM expression 2.5 hours earlier than those in Group 2. Overall, BM production was higher in Group 1. Limitations: This study had a relatively small sample size (n=19). Only mothers delivering 31- 33 weeks gestation were included. This is a single-center study, which may limit generalizability. Conclusion: Prenatal lactation education of mothers of preterm infants and their SP is feasible and may increase lactation success. ( en )
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Awarded Bachelor of Science in Nursing, magna cum laude, on May 8, 2018. Major: Nursing
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College or School: College of Nursing
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Advisor: Leslie Parker. Advisor Department or School: Nursing

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Copyright Morgan Leigh Richburg. Permission granted to the University of Florida to digitize, archive and distribute this item for non-profit research and educational purposes. Any reuse of this item in excess of fair use or other copyright exemptions requires permission of the copyright holder.

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Running head: EFFECT OF PRENATAL LACTATION EDUCATION Effect of Prenatal Lactation Education on Lactation Success in Mothers at Risk of Preterm Delivery Morgan L. Richburg University of Florida

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EFFECT OF PRENATAL LACTATION EDUCATION Abstract Background: Mothers of preterm infants often produce insufficient amounts of breast milk ( BM ) Early initiation of BM expression following delivery is associated with increased lactation success but lack of nursing time delays BM expression in this population. Purpose: To determine if providing antenatal breast expression education to the support person ( SP ) of mothers at risk of preterm delivery improves lactation success. Methods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his study had a relatively small sample size (n=19). Only mothers delivering 31 33 weeks gestation were included. This is a single center study which may limit generalizability. /,-0%$#),' 8,%&+'+2"2+?'+'-)&"% 1:?+'-)&")0"*)'6%,.")0"5,%'%,* -&0+&'."+&1"'6%-,"78"-." 0%+.-@2%"+&1"*+(" -&?,%+ .%"2+?'+'-)&".:??%.. ; "

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EFFECT OF PRENATAL LACTATION EDUCATION I Effect of Prenatal Lactation Education on Lactation Success in Mothers at Risk of Preterm Delivery More than 1 in 10 infants are born prematurely (before 37 weeks gestation) each year (WHO, 2017 ). This amounts to approximately 15 million infants each year, and due to improvements in technology, that number is rising (WHO, 2017). Preterm birth is the most common cause of infant death in the United States, and has contributed to 34.3% of all infant deaths ( Callaghan, MacDorman, Rasm ussen, Qin, & Lackritz, 2006) Death is most often due to complications of prematurity such as necrotizing enterocolitis (NEC) and sepsis Given the severity of these complications, it is imperative that we find ways to decrease the incidence and improve health outcomes for premature infants. The use of BM for term infants is widely accepted as the opti mal form of nutrition due to it s nutritional gastrointestinal, immunological, developmental, and psychological benefits (Callen & Pinelli 2005). BM has t he ideal composition of amino acids, fatty acids, and carbohydrates and has been shown to decrease the incidence of feeding intolerance (Callen & Pinelli 2005). BM for infant consumption is one of the national goals of Healthy People 2020. More recently, BM has also become recognized as the gold standard for nutrition in premature infants. BM has illustrated persiste nt benefits 30 months after discharge from the NICU (Vohr et al. 2007) Extremely Low Birth Weight ( ELBW ) infants show improved neu rodevelopmental outcomes such as improved cognition and emotional regulation; a s well as fewer rehospitalizations when fed BM (Vohr et al. 2007). BM offers especially important benefits to preterm infants in the NICU For example, BM has been shown to re duce the incidence of NEC and death (Sisk, Lovelady, Dillard, Gruber, & O'Shea, 2007) ( Meinzen Derr et. al 2009) (Parish & Bhatia 2008) Previously, t here was some concern that BM was

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EFFECT OF PRENATAL LACTATION EDUCATION J insufficient to meet the increased metabolic needs of very low birth weight ( VLBW ) infants bec ause it is less nutrient dense than formula However, BM can be fortified to address these concerns and still offer additional benefits not present in formula ( Henderson, McGuire, & Antony 2007). Despite the well documented benef its of BM only 50% of mothers of preterm infants are breastfeeding at the time of discharge from the NICU (Callen & Pinelli 2005). Mothers of premature infants face multiple significant barriers to breastfeeding that include learning a new skill, as well as establishing and maintaining a milk supply. Premature infants are often too weak to breastfeed and too immature to coordinate the intricacies of sucking, swallowing and breathing simu ltaneously (Callen & Pinelli 2005). Therefore, mothers must stimulate their own BM expression for weeks to months before the infant is able to breastfeed (Callen & Pinelli 2005). This presents many unique challenges, as mothers must learn the new skill of BM expression while also coping wit h separation from their infant ( Ikonen, Paavilainen, & Kaunonen, 2016) In multiple studies, mothers of preterm infants cite inadequate BM supply as a primary barrier to breastfeeding (Callen & Pinelli 2005) ( Ikonen et al., 2016) In a qualitative study of 150 mothers of preterm infants, feelings of unfamiliarity, difficulty, frustration and loneliness were often experienced when attempting to express BM ( Ikonen et al., 2016) Mothers also reported a lack of available pumps as a barrier to BM expression ( Ikonen et al., 2016) Lactogenesis stage II is the change from small quantities of colostrum to copious amounts of breast milk. In term mothers, this usually occurs 30 to 48 hours following delivery (Parker, Sullivan, Krueger, Kelechi & Mueller 2012). Delay in lactogenesis stage II is common in all mothers with 22 to 31% of women entering this stage 72 hours after delivery and is

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EFFECT OF PRENATAL LACTATION EDUCATION G associated with decreased success in later lactation (Parker et al. 2012). BM volume is correlated with gestational age, s o mothers of preterm infants have a tendency to produce significantly less BM than mothers of term infants (Parker et al., 2012). Preterm delivery and a delay in breastfeeding have been associated with a later onset lactogenesis stage II (Parker et al. 20 12). Early initiation of BM expression following delivery and frequent expression thereafter is associated with increased lactation success (Callen & Pinelli 2005) (Parker et al. 2012) The labor & delivery bedside nurse usually facilitates the initial BM expression session. Unfortunately, inadequate staffing and lack of nursing time prevent the nurse from assisting the new mother in expressing BM sooner (Parker, Sullivan, Hoffman, & Darcy Mahoney, 2018). As a result, BM expression is commonly delayed in this population. In our study we wanted to empower women and their support person (SP) to begin BM expression without the intervention of a nurse. It is unknown whether p roviding education to the SP of mothers at risk of preterm delivery will improve l actation success. T he refore, the purpose of this pilot study is to determine if providing antenatal breast expression education to the SP of mothers at risk of preterm delivery is safe, feasible, and improves lactation success. Methods This was a randomi zed control pilot study of 20 women at risk for delivering preterm infants and their support person (SP). 20 mothers who were hospitalized anticipating the del ivery of a premature infant were sampled by convenience from a maternity unity at UF Health Shands teaching hospital, a Level III tertiary care center. T he hospital includes a Level IV NICU. The dyads were consented prior to delivery and randomized into 1 of 2 groups. Mothers and their S P in Group 1 (Education Group) received an education video regarding the benefits of BM for

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EFFECT OF PRENATAL LACTATION EDUCATION K premature infants a video and demonstration on how to use a breast pump and a hospital grade breast pump was placed into their hospital room prior to delivery Gr oup 2 (Standard Care Group) received standard care. They did not view the education video and were given a hospital grade breast pump after delivery, but before discharge per current hospital practice. We defined the SP as whoever was going to be at the bedside with the mother during delivery. This could be a spouse or significant other, a family member, such as a mother or sister, or even a close friend. Inclusion criteria were mothers expected to deliver an infant between 32 and 34 weeks gestation, moth er and support person older than 18 years of age, English speaking, and mother's desire to breastfeed. Exclusion criteria were infant demise predicted to occur within 2 weeks of delivery infants less than 32 weeks and less than 1500 grams, or infants greater than 34 weeks Additional e xclusion criteria wer e mothers who were HIV positive, non Engli sh speaking, document ed history of unlawful drug use or mammoplasty One mother was removed from this study because she did not attempt to express BM BM volume was measured daily for 2 weeks by BM technicians blinded to the group assignment and who weighed all expressed BM Time to lactogenesis stage II was determined by calculating time from delivery to production of greater than or equal to 20 mL of BM in 2 consecutive expression sessions. Data regarding time to first BM expression was collected from patient charts. Data was stored in Red Cap and analyzed using Microsoft Excel to calculate means and perform t tests. Project Narrative This study was initially implemented in 2014 at UF Health in Gainesville, Florida. The original study yielded results on time to lactogenesis stage II, and time to first BM expression. Data was also collected for BM volumes, but it had some errors and gaps therefore it was

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EFFECT OF PRENATAL LACTATION EDUCATION L inconclusive. In fall of 2017, I began to comb through the old data, in an attempt to extract more information and draw further conclusions. The original study analyzed milk volume from D1 7, 14, and 21. However, this data did not tell t he full picture. The original analysis did not take into account infants who were discharged prior to day 21. Instead, the mother's milk volume was falsely recorded as zero milliliters. I went back to the original milk logs to extract data on the milk volu mes for all 21 days. I corrected clerical and mathematical errors I found along the way. Additionally, when I analyzed the data, subjects were excluded from calculations if they had been discharged from the hospital. To maintain the largest possible sample size, I decided to only analyze milk volume up to day 14. Key stakeholders throughout this process included the participants, especially the SP, as he or she had an active desire to learn and help the mother breastfeed. The BM technicians were also criti cal for accurately weighing and recording BM volumes. Lastly, my mentor, Dr. Parker and the team of students working on this project were cr ucial in implementing the project and analyzing the data. Results As depicted in the table below, the demographics for the two groups were very similar. Notice the average gestational age was identical for the two groups. Additionally, average maternal age and infant birth weight were very similar. " 12$0+&),-.34,$5.6-789 :&+-2+42./+4".6-7;<9 =+&"4-+%.>?" !L;J"(%+,. J;J"(%+,. 3"#&+&),-+%.>?" I!;J"$%%/. I!;J"$%%/. @)4&A.B")?A& >MGI;J"4,+*. >MI!;K"4,+*. /+$0+#)+. G"NGG;KOP L"NLQOP" >C4)0+-.>*"4)0+. !"N!!;!OP I"NIQOP >#)+. >"N>>;>OP Q"NQOP D&A"4 >"N>>;>OP Q"NQOP E4""0%+*5#)+ !"N!!;!OP G"NGQOP

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EFFECT OF PRENATAL LACTATION EDUCATION R +3%,+4%">IG;R"*W"*),%"B<"'6+&"'6%"7'+&1+,1"U+,%"=,):5;"B("A>JC"'6%"4+5"?2).%1C"+&1"'6%" T1:?+'-)&"=, ):5"6+1"5,)1:?%1")&"+3%,+4% !!;M>"*W"*),%"'6+&"'6%"7'+&1+,1"U+,%"4,):5;" X)&%")0"'6%"1+'+",% 4+,1-&4"1-00%,%&?%."+*):&4 '6%"*-2/"3)2:*%."0),"'6%" '$)"4,):5."$+." .'+'-.'-?+22(".-4&-0-?+&' N5Y"Q;QGP ; S22"-&"+22C"' 6%"T1:?+'-)&"=,):5"6+1"6-46%,"')'+2"*-2/" 3)2:*%"0),"A> Z >J; """""""""""""""""""""""""""""""""""""""" Discussion When implementing this pilot study, we hoped to find that an antenatally delivered lactation education program for SP of mothers at risk of preterm delivery was safe and feasible. We were pleased to find that it was safe, and feasible Moreover, we hoped that mothers whose SP received anten atal education would have increased lactation success. Namely, we hoped to find decreased time to fist BM expression, decreased time to lactogenesis stage II, and increased milk volume. Mothers whose SP received antenatal education began BM expression 2.5 hours earlier than the Standard Care Group These results are encouraging since prompt BM expression following delivery is associated with increased lactation success (Parker et al., 2012). However, r egardless of education, mothers initiated expression m uch later than current standard care !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!"#"$%&!'()!*+$),-$!./01!2(034$% !!!!5637,&/(8 !9&,86,)6!:,)$! !!!!!!!!!!!!.$,8! !!!!!!!!!!!!!!!!!!.$,8 !!!!!!!!!!!!!!!!!!!!;!+,03$! <,=!> ?@ABC ?DADE DAFG <,=!? >>AFF FAF> DAHG <,=!@ EDA@@ E>AC DACE <,=!E ??HA>B >DHA@B DA>G <,=!G @E@A? ?@GAG DAE <,=!H ED?A?? EECA@C DAF? <,=!B EEGA?? @DCA@? DA@G <,=!F E@FADC EFFAFB DAF <,=!C ECEAFG E@DACH DABE <,=!>D @FCAH@ E@CAFG DABB <,=!>> @C>A>B EGDAE DABE <,=!>? @FEA@> E?BAE> DAFH <,=!>@ EBDAFF @CFAF> DABE <,=!>E @H>ACC ECDAG DAHC "(&,0I!<,=%!>#B ??CA>@ >B@AC DA?C "(&,0I!<,=%!>#>E @?BA?C @DEAEF DAH@

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EFFECT OF PRENATAL LACTATION EDUCATION >Q ( within 6 hours after delivery) and far from the 1 hour after delivery window to promote optimal BM supply (Parker et al. 2012). Overall, BM productio n was higher on nearly every day in the first week for mothers in the education group Since early BM volume is associated with adequacy of later milk volume, supporting mothers during the early postpartum period is vital (Parker et al., 2012). Mothers in the Education Group also had higher total BM volume for the first two weeks. W hile not statistically significant, these findings may be clinically important in mothers at risk of insufficient BM production and for prete rm infants who are consuming small quantities of BM Limitations This study had a relatively small sample size (n=19). Furthermore, o nly mothers delivering 31 33 weeks gestation were included. Lastly, t his is a single center study which may limit generalizability. Conclusion The purpose of this pilot study was to det ermine if providing antenatal breast expression education to the SP of mothers at risk of preterm delivery is safe, feasible, and improves lactation success. We found a prenatally delivered education program to be safe and effective. Additionally, we found a ntenatal education of SPs of mothers at risk of delivering a preterm infant decrease d time to initial BM expression. While not statistically significant, BM volume was increased on nearly every day for the first 7 days which may be clinically significan t for mothers with limited BM production. This project has been invaluable for my own learning and professional development I have learne d the research process, gained new skills using Microsoft excel, and discovered how rewarding research can be. Moreover, these findings are meaningful for nurses because they can

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EFFECT OF PRENATAL LACTATION EDUCATION >> intervene to educate patients on the use of a breast pump prior to delivery. Nurses should also be mindful to include the support person in the teaching. Lastly, t hese results are meaning ful for patient care because new mothers with a support person should be empowered to improve their lactation success by taking action to initiate BM expression soon after delivery. Overall, the project was a success because it was safe, feasible, and ha d encouraging initial results. A larger, more comprehensive study including a larger sample size various gestational ages, and multiple centers is needed to definitively determine whether antenatal education of SPs improves lactation success in mothers de livering preterm infants and to create clinical recommendations "

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EFFECT OF PRENATAL LACTATION EDUCATION >! [%0%,%&?%. Callaghan, W. M., MacDorman, M. F., Rasmussen, S. A., Qin, C., & Lackritz, E. M. (2006). The contribution of preterm birth to infant mortality rates in the United States. Pediatrics 118 (4), 1566 1573. http://dx.doi.org/10.1542/peds.2006 0860 Callen, J., & Pinelli, J. (2005). A review of the literature examining the be nefits and challenges, incidence and duration, and barriers to breastfeeding in preterm infants. Advanced Neonatal Care 5 (2), 72 88. Henderson, G., McGuire, W., & Antony, M. (2007). Formula milk versus maternal breast milk for feeding preterm or low birth weight infants. Cochrane Neonatal Review Ikonen, R., Paavilainen E., & Kaunonen, M. (2016). Trying to live with pumping: Expressing milk for preterm or small fo r gestational age infants. The American Journal of Maternal Child Nursing 41 (2), 110 115. http://dx.doi.org/10.1097/NMC.0000000000000214 Institute of Medicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcomes. (2007). Preterm b irth: Causes, consequences, and prevention (R. E. Behrman & A. S. Butler, Eds.). http://dx.doi.org/10.17226/11622 Meinzen Derr, J., Poindexter, B., Wrange, L., Morrow, A. L., Stoll, B., & Donovan, E. F. (2009). Role of human milk in extremely low birth wei ght infants' risk of necrotizing enterocolitis or death. Journal of Perinatology 29 57 62. http://dx.doi.org/doi:10.1038/jp.2008.117 Parish, A., & Bhatia, J. (2008). Feeding strategies in the ELBW infant. Journal of Perinatology 28 18 20. http://dx.doi .org/doi:10.1038/jp.2008.45 Parker, L., Sullivan, S., Krueger, C., Kelechi, T., & Mueller, M. (2012). Effect of early breast milk expression on milk volume and timing of lactogenesis stage II among mothers of

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EFFECT OF PRENATAL LACTATION EDUCATION >I very low birth weight infants: A pilot study. J ournal of Perinatology 32 205 209. http://doi:10.1038/jp.2011.78 Parker, L., Sullivan, Hoffman, J., & Darcy Mahoney, A. (2018). Facilitating Early Breast Milk Expression in Mothers of Very Low Birth Weight Infants. The American Journal of Maternal/Child Nursing, 43(2) 105 110. http:// doi: 10.1097/NMC.0000000000000408 Sisk, P. M., Lovelady, C. A., Dillard, R. G., Gruber, K. J., & O'Shea, T. M. (2007). Early human milk feeding is associated with a lower risk of necrotizing enterocolitis in ver y low birth weight infants. Journal of Perinatology 27 428 433. http://dx.doi.org/10.1038/sj.jp.7211758 Vohr, B. R., Poindexter, B. B., Dusick, A. M., McKinley, L. T., Higgins, R. D., Langer, J. C., & Poole, W. K. (2007). Persistent beneficial effects of breast milk ingested in the neonatal intensive care unit on outcomes of extremely low birth weight infants at 30 months of age. Pediatrics 120 (4), 953 959. http://dx.doi.org/10.1542/peds.2006 3227 World Health Organization. (2017, November). Preterm birth. Retrieved March 7, 2018, from World Health Organization website: http://www.who.int/mediacentre/factsheets/fs363/en/ " " " "

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EFFECT OF PRENATAL LACTATION EDUCATION >J S55%&1-D"S E[B"S55,)3+2 Health Center Institutional Review Board FWA00005790 PO Box 100173 Gainesville FL 32610 0173 Telephone: (352) 273 9600 Facsimile: (352) 273 9614 DATE: 6/29/2015 TO: Leslie Parker Box 100187 College of Nursing Gainesville Florida 32610 FROM: Peter Iafrate, Pharm.D Chair IRB 01 IRB#: 2015 Review for IRB201400318 TITLE: Prenatal breast pumping education of mothers and their support person Approved as Expedited: Continuing Review Expires on: 7/1/2018 Discretionary Policy in Effect On 6/25/2015 the IRB re approved you to continue conducting the above listed research project. You are approved to enroll 80 subjects. This study is approved as expedited because it poses minimal risk and is approved under the following expedited category/categories: 7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluat ion, or quality assurance methodologies. [Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. (45 CFR 46.101(b)(2) and (b)(3).) This listing refers only to research that is not exempt.] Appro val Includes: Dated and watermarked IRB approved Informed Consent Forms ("Mother" and "Support Person") Principal Investigator Responsibilities: The PI is responsible for the conduct of the study. Please review these responsibilities described at: http://irb.ufl.edu/irb01/researcher information/researcherresponsibilities.html Important responsibilities described at the above link include: Usin g currently approved consent form to enroll subjects (if applicable) Renewing your study before expiration Obtaining approval for revisions before implementation Reporting Adverse Events Retention of Research Records Obtaining approval to conduct research at the VA Notifying other parties about this project's approval status cc: Ashley Glynn Amy Pucek Amelia Schlak The Foundation for The Gator Nation An Equal Opportunity Institution