A Study of Effects of Delay in the First Bathing Time of Body Temperature and the Rate of Exclusive Breastfeeding

Overview

Using delaying the first bathing by 8 hours as an interventional measure, considering the consistent effect of physiological maturity, newborns with a gestational age of ≥37 weeks were selected as the subjects in the nursery cases, and randomly assigned to the delayed bathing group and the routine bathing group , 10 minutes before bathing, immediately after bathing, 10 minutes, 30 minutes, and 60 minutes to analyze the differences in body temperature of the cases, and the differences in the rate of exclusive breastfeeding at discharge.

Full Title of Study: “A Study of Effects of Delay in the First Bathing Time of Newborns on the Rate of Body Temperature and the Rate of Exclusive Breastfeeding: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 25, 2022

Detailed Description

The subjects of this study came from newborn babies in the nursery of a teaching hospital in the northern region. The research design was reviewed and approved by the Human Trials Committee. Can freely choose whether to participate in the research project or withdraw, willing participants to inform the research project and fill in the consent form and basic information form, inform that they can withdraw at any time during the research period, and divide the participating infants into the experimental group and the control group through a random allocation form , after the newborn arrives in the baby room, the nursing staff will evaluate the newborn, and then perform an oil bath with baby oil to remove the fetal fat on the body, and then follow the newborn bathing procedure of our hospital. Wash the whole body with water, about 1-2 hours after birth; the control group took the first bath as usual; the experimental group postponed the last step of washing the whole body after washing the face and head to 8 hours after birth , personnel must wear gloves to take care of newborns before bathing. The bathing process was performed by nurses in the baby room. Body temperature was measured 10 minutes before, immediately after, 10 minutes, 30 minutes, and 60 minutes after bathing, and the exclusive breastfeeding situation at the time of discharge was counted. After all measurements are completed, a 100 yuan supermarket coupon will be given.

Interventions

  • Behavioral: Delay first bath
    • Newborns delay first bath to 8 hours after birth

Arms, Groups and Cohorts

  • Experimental: delayed first bath time
    • Delay first bath to 8 hours after birth
  • No Intervention: regular bath
    • Birth temperature 36.5°C, regular bath

Clinical Trial Outcome Measures

Primary Measures

  • body temperature after bath
    • Time Frame: temperature measurement : 10 minutes after bathing
    • The degree of decrease in body temperature after bathing compared to before bathing

Secondary Measures

  • Exclusive breastfeeding rate
    • Time Frame: 3 to 5 days
    • Neonatal feeding methods during hospitalization

Participating in This Clinical Trial

Inclusion Criteria

  • Apparently normal newborn with status ranging from normal to good – mean gestational age ≥37 weeks – birth weight ≥2500 g – Apgar score of at least 7 within 1-5 minutes – birth rectal temperature ≥36.5°C – without any major change or signs or symptoms of sepsis. Exclusion Criteria:

  • The mother is younger than 20 years old – has recently had symptoms of fever, leukocytosis, respiratory tract infection or urinary tract infection – the mother has diseases such as diabetes, hyperthyroidism, and a positive history of type B streptococcus or other blood and body fluid infectious diseases.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cardinal Tien Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Di-Ling Huang, Head nursing – Cardinal Tien Hospital

References

Wang Yating, Wang Xiuhe, Wu Sujin, Zheng Yufang, Liao Wenling (2014). A study on the choice of feeding method and its related factors in parturients. Joseph Medical Journal, 8(1), 5-16.

Lin Yujing, Yang Jialing, Gao Meihua, Li Jingyi (2012). Correlation between perinatal breastfeeding instruction and maternal practice of 24-hour parent-child rooming. Chang Gung Nursing, 23(1), 27-40.

Lin YW, Tzeng YL, Yang YL. [Mother-friendly childbirth practices and breastfeeding]. Hu Li Za Zhi. 2013 Feb;60(1):5-10. doi: 10.6224/JN.60.1.5. Chinese.

Ke Huijuan, Zhong Yulun, Chen Shufen (2019). A retrospective cohort study on the effect of continuous exclusive breastfeeding on the 24-hour parent-child rooming strategy in a medical center. Rong Total Nursing, 36(4), 343-352.

Xu Yufen, Liu Xinyi, Li Zhaohui, Chen Shujuan (2010). Improvement programs to reduce the incidence of neonatal hypothermia. Journal of Midwifery, 52, 93-104.

Gao Yuxiu, Li Fengxue, and Wang Guoming (2012). Influence of primipara background factors on breastfeeding experience and self-efficacy. Journal of Midwifery, 54, 56-67.

Chen Guanying, Wei Ziyi, Huang Xiaoyu, Xu Yunxin (2019). A project to improve hypothermia for neonates admitted to the moderate-severe ward in the delivery room. Journal of Nursing, 66(4), 71-78.

You Shuzhen (2018). Discussion on the related factors of continuous breastfeeding in postpartum women.

Ye Jinxue (2015). The Guardianship of Successful Breastfeeding. Taiwan Medicine, 19(6), 643-649.

Anderson J. An Organization-Wide Initiative to Implement Parent-Performed, Delayed Immersion Bathing. Nurs Womens Health. 2021 Feb;25(1):63-70. doi: 10.1016/j.nwh.2020.11.006. Epub 2021 Jan 13.

Association of Women's Health, Obstetric and Neonatal Nurses. (2018). Neonatal skin care: Evidence-based clinical practice guideline (4th ed.). AWHONN.

Bhutta ZA, Das JK, Bahl R, Lawn JE, Salam RA, Paul VK, Sankar MJ, Blencowe H, Rizvi A, Chou VB, Walker N; Lancet Newborn Interventions Review Group; Lancet Every Newborn Study Group. Can available interventions end preventable deaths in mothers, newborn babies, and stillbirths, and at what cost? Lancet. 2014 Jul 26;384(9940):347-70. doi: 10.1016/S0140-6736(14)60792-3. Epub 2014 May 19. Erratum In: Lancet. 2014 Jul 26;384(9940):308. Sankar, Jeeva M [corrected to Sankar, M Jeeva].

Binns C, Lee MK, Kagawa M. Ethical Challenges in Infant Feeding Research. Nutrients. 2017 Jan 11;9(1):59. doi: 10.3390/nu9010059.

Bissinger RL, Annibale DJ. Thermoregulation in very low-birth-weight infants during the golden hour: results and implications. Adv Neonatal Care. 2010 Oct;10(5):230-8. doi: 10.1097/ANC.0b013e3181f0ae63. Erratum In: Adv Neonatal Care. 2010 Dec;10(6):351.

Blackburn, S. T., (2003). Thermoregulation. In S. T. Blackburn (Ed.), Maternal, fetal, & neonatal physiology: A clinical perspective (2nd ed., pp. 707-730). Philadelphia, Saunders.

Bowden, V. R., & Greenberg, C. S. (2010). Children and their families: The continuum of care. Lippincott Williams & Wilkins.

Lund CH, Osborne JW, Kuller J, Lane AT, Lott JW, Raines DA. Neonatal skin care: clinical outcomes of the AWHONN/NANN evidence-based clinical practice guideline. Association of Women's Health, Obstetric and Neonatal Nurses and the National Association of Neonatal Nurses. J Obstet Gynecol Neonatal Nurs. 2001 Jan-Feb;30(1):41-51.

Brogan J, Rapkin G. Implementing Evidence-Based Neonatal Skin Care With Parent-Performed, Delayed Immersion Baths. Nurs Womens Health. 2017 Dec;21(6):442-450. doi: 10.1016/j.nwh.2017.10.009.

Byaruhanga R, Bergstrom A, Okong P. Neonatal hypothermia in Uganda: prevalence and risk factors. J Trop Pediatr. 2005 Aug;51(4):212-5. doi: 10.1093/tropej/fmh098. Epub 2005 May 25.

Medoff Cooper B, Holditch-Davis D, Verklan MT, Fraser-Askin D, Lamp J, Santa-Donato A, Onokpise B, Soeken KL, Bingham D. Newborn clinical outcomes of the AWHONN late preterm infant research-based practice project. J Obstet Gynecol Neonatal Nurs. 2012 Nov-Dec;41(6):774-85. doi: 10.1111/j.1552-6909.2012.01401.x. Epub 2012 Aug 3.

Crenshaw JT. Healthy Birth Practice #6: Keep Mother and Baby Together- It's Best for Mother, Baby, and Breastfeeding. J Perinat Educ. 2014 Fall;23(4):211-7. doi: 10.1891/1058-1243.23.4.211.

DiCioccio HC, Ady C, Bena JF, Albert NM. Initiative to Improve Exclusive Breastfeeding by Delaying the Newborn Bath. J Obstet Gynecol Neonatal Nurs. 2019 Mar;48(2):189-196. doi: 10.1016/j.jogn.2018.12.008. Epub 2019 Jan 21.

DiGirolamo AM, Grummer-Strawn LM, Fein SB. Effect of maternity-care practices on breastfeeding. Pediatrics. 2008 Oct;122 Suppl 2:S43-9. doi: 10.1542/peds.2008-1315e.

Eidelman AI. Breastfeeding and the use of human milk: an analysis of the American Academy of Pediatrics 2012 Breastfeeding Policy Statement. Breastfeed Med. 2012 Oct;7(5):323-4. doi: 10.1089/bfm.2012.0067. Epub 2012 Sep 4. No abstract available.

Fernandez D, Antolin-Rodriguez R. Bathing a Premature Infant in the Intensive Care Unit: A Systematic Review. J Pediatr Nurs. 2018 Sep-Oct;42:e52-e57. doi: 10.1016/j.pedn.2018.05.002. Epub 2018 May 18.

Gardner, S. L., Carter, B. S., Enzman-Hines, M. I., & Niermeyer, S. (2020). Merenstein & Gardner's Handbook of Neonatal Intensive Care-E-Book: An Interprofessional Approach. Elsevier Health Sciences.

George S, Phillips K, Mallory S, Holmquistova I, Hare R, Allen S, Higgins M, Shapiro SE. A pragmatic descriptive study of rewarming the newborn after the first bath. J Obstet Gynecol Neonatal Nurs. 2015 Mar-Apr;44(2):203-9. doi: 10.1111/1552-6909.12556. Epub 2015 Feb 24.

Hackman PS. Recognizing and understanding the cold-stressed term infant. Neonatal Netw. 2001 Dec;20(8):35-41. doi: 10.1891/0730-0832.20.8.35.

Hughes Driscoll CA, Pereira N, Lichenstein R. In-hospital Neonatal Falls: An Unintended Consequence of Efforts to Improve Breastfeeding. Pediatrics. 2019 Jan;143(1):e20182488. doi: 10.1542/peds.2018-2488.

Kelly PA, Classen KA, Crandall CG, Crenshaw JT, Schaefer SA, Wade DA, Cramer MN, Aryal S, Fossee KR. Effect of Timing of the First Bath on a Healthy Newborn's Temperature. J Obstet Gynecol Neonatal Nurs. 2018 Sep;47(5):608-619. doi: 10.1016/j.jogn.2018.07.004. Epub 2018 Aug 8.

Knobel, R. B., (2014). Fetal and neonatal thermal physiology. Newborn and Infant Nursing Reviews, 14(2), 45-49.

Koopman I, Callaghan-Koru JA, Alaofin O, Argani CH, Farzin A. Early skin-to-skin contact for healthy full-term infants after vaginal and caesarean delivery: a qualitative study on clinician perspectives. J Clin Nurs. 2016 May;25(9-10):1367-76. doi: 10.1111/jocn.13227. Epub 2016 Mar 30.

Kuller, J. M., (2014). Update on newborn bathing. Newborn and Infant Nursing Reviews, 14(4), 166-170.

Laptook AR, Salhab W, Bhaskar B; Neonatal Research Network. Admission temperature of low birth weight infants: predictors and associated morbidities. Pediatrics. 2007 Mar;119(3):e643-9. doi: 10.1542/peds.2006-0943. Epub 2007 Feb 12.

Laptook A, Jackson GL. Cold stress and hypoglycemia in the late preterm ("near-term") infant: impact on nursery of admission. Semin Perinatol. 2006 Feb;30(1):24-7. doi: 10.1053/j.semperi.2006.01.014.

Liberth, M., & Fontana, J. (2018). Benefits of Delayed Bathing. Journal of Obstetric, Gynecologic & Neonatal Nursing, 47(3), S30-S31

Lipka, D. V., & Schulz, M. K. (2012). "Wait for eight": Improvement of newborn outcomes by the implementation of newborn bath delay. Journal of Obstetric, Gynecologic, & Neonatal Nursing, 41(s1), S46-S47.

Lund C. Bathing and Beyond: Current Bathing Controversies for Newborn Infants. Adv Neonatal Care. 2016 Oct;16 Suppl 5S:S13-S20. doi: 10.1097/ANC.0000000000000336.

Lunze K, Bloom DE, Jamison DT, Hamer DH. The global burden of neonatal hypothermia: systematic review of a major challenge for newborn survival. BMC Med. 2013 Jan 31;11:24. doi: 10.1186/1741-7015-11-24.

Mardini J, Rahme C, Matar O, Abou Khalil S, Hallit S, Fadous Khalife MC. Newborn's first bath: any preferred timing? A pilot study from Lebanon. BMC Res Notes. 2020 Sep 14;13(1):430. doi: 10.1186/s13104-020-05282-0.

Merazzi D, Bresesti I, Tagliabue P, Valsecchi MG, De Lorenzo P, Lista G; Collaboration Group. Body temperature at nursery admission in a cohort of healthy newborn infants: results from an observational cross-sectional study. Ital J Pediatr. 2020 Apr 15;46(1):46. doi: 10.1186/s13052-020-0810-z.

Merten S, Dratva J, Ackermann-Liebrich U. Do baby-friendly hospitals influence breastfeeding duration on a national level? Pediatrics. 2005 Nov;116(5):e702-8. doi: 10.1542/peds.2005-0537.

Moore ER, Bergman N, Anderson GC, Medley N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2016 Nov 25;11(11):CD003519. doi: 10.1002/14651858.CD003519.pub4.

Hellwig JP. Providing evidence-based care: ANA launches research toolkit. Nurs Womens Health. 2011 Dec;15(6):545-6. doi: 10.1111/j.1751-486X.2011.01688.x. No abstract available.

Ng CA, Ho JJ, Lee ZH. The effect of rooming-in on duration of breastfeeding: A systematic review of randomised and non-randomised prospective controlled studies. PLoS One. 2019 Apr 25;14(4):e0215869. doi: 10.1371/journal.pone.0215869. eCollection 2019.

Patel A, Bucher S, Pusdekar Y, Esamai F, Krebs NF, Goudar SS, Chomba E, Garces A, Pasha O, Saleem S, Kodkany BS, Liechty EA, Kodkany B, Derman RJ, Carlo WA, Hambidge K, Goldenberg RL, Althabe F, Berrueta M, Moore JL, McClure EM, Koso-Thomas M, Hibberd PL. Rates and determinants of early initiation of breastfeeding and exclusive breast feeding at 42 days postnatal in six low and middle-income countries: A prospective cohort study. Reprod Health. 2015;12 Suppl 2(Suppl 2):S10. doi: 10.1186/1742-4755-12-S2-S10. Epub 2015 Jun 8.

Perlman JM, Wyllie J, Kattwinkel J, Wyckoff MH, Aziz K, Guinsburg R, Kim HS, Liley HG, Mildenhall L, Simon WM, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 7: Neonatal Resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2015 Oct 20;132(16 Suppl 1):S204-41. doi: 10.1161/CIR.0000000000000276. No abstract available.

Perlman J, Kjaer K. Neonatal and Maternal Temperature Regulation During and After Delivery. Anesth Analg. 2016 Jul;123(1):168-72. doi: 10.1213/ANE.0000000000001256.

Preer G, Pisegna JM, Cook JT, Henri AM, Philipp BL. Delaying the bath and in-hospital breastfeeding rates. Breastfeed Med. 2013 Dec;8(6):485-90. doi: 10.1089/bfm.2012.0158. Epub 2013 May 2.

Rito AI, Buoncristiano M, Spinelli A, Salanave B, Kunesova M, Hejgaard T, Garcia Solano M, Fijalkowska A, Sturua L, Hyska J, Kelleher C, Duleva V, Music Milanovic S, Farrugia Sant'Angelo V, Abdrakhmanova S, Kujundzic E, Peterkova V, Gualtieri A, Pudule I, Petrauskiene A, Tanrygulyyeva M, Sherali R, Huidumac-Petrescu C, Williams J, Ahrens W, Breda J. Association between Characteristics at Birth, Breastfeeding and Obesity in 22 Countries: The WHO European Childhood Obesity Surveillance Initiative – COSI 2015/2017. Obes Facts. 2019;12(2):226-243. doi: 10.1159/000500425. Epub 2019 Apr 26.

Ruschel LM, Pedrini DB, Cunha MLCD. Hypothermia and the newborn's bath in the first hours of life. Rev Gaucha Enferm. 2018 Oct 22;39:e20170263. doi: 10.1590/1983-1447.2018.20170263. English, Portuguese.

Russo A, McCready M, Torres L, Theuriere C, Venturini S, Spaight M, Hemway RJ, Handrinos S, Perlmutter D, Huynh T, Grunebaum A, Perlman J. Reducing hypothermia in preterm infants following delivery. Pediatrics. 2014 Apr;133(4):e1055-62. doi: 10.1542/peds.2013-2544. Epub 2014 Mar 31.

SILVERMAN WA, FERTIG JW, BERGER AP. The influence of the thermal environment upon the survival of newly born premature infants. Pediatrics. 1958 Nov;22(5):876-86. No abstract available.

Singh G, Archana G. Unraveling the mystery of vernix caseosa. Indian J Dermatol. 2008;53(2):54-60. doi: 10.4103/0019-5154.41645.

Stamatas GN, Nikolovski J, Luedtke MA, Kollias N, Wiegand BC. Infant skin microstructure assessed in vivo differs from adult skin in organization and at the cellular level. Pediatr Dermatol. 2010 Mar-Apr;27(2):125-31. doi: 10.1111/j.1525-1470.2009.00973.x. Epub 2009 Oct 4.

Suchy C, Morton C, Ramos RR, Ehrgott A, Quental MM, Burridge A, Rutledge DN. Does Changing Newborn Bath Procedure Alter Newborn Temperatures and Exclusive Breastfeeding? Neonatal Netw. 2018 Jan 1;37(1):4-10. doi: 10.1891/0730-0832.37.1.4.

Takayama JI, Teng W, Uyemoto J, Newman TB, Pantell RH. Body temperature of newborns: what is normal? Clin Pediatr (Phila). 2000 Sep;39(9):503-10. doi: 10.1177/000992280003900901.

Trevisanuto, D., & Sedin, G. (2018). Physical environment for newborns: the thermal environment. Neonatology. A Practical Guide to Neonatal Diseases. 2nd ed. Milan: SpringerVerlag

Verklan, M. T., & Walden, M. (2004). Thermoregulation. In M. T. Verklan & M. Walden (Eds.), Core curriculum for neonatal intensive care nursing (3rd ed., pp. 125-134). St. Louis, MO: Saunders.

Warren S, Midodzi WK, Allwood Newhook LA, Murphy P, Twells L. Effects of Delayed Newborn Bathing on Breastfeeding, Hypothermia, and Hypoglycemia. J Obstet Gynecol Neonatal Nurs. 2020 Mar;49(2):181-189. doi: 10.1016/j.jogn.2019.12.004. Epub 2020 Feb 12.

Weiner, G.M., Zaichkin, J., & Kattwinkel, J. (2016). Textbook of neonatal resuscitation (7th ed., pp. 17-65). Elk Grove Village, IL: American Academy of Pediatrics.

World Health Organization. (1993). Thermal control of the newborn: a practical guide (No. WHO/FHE/MSM/93.2). World health organization

World Health Organization. (1997). Thermal protection of the newborn: a practical guide (No. WHO/RHT/MSM/97.2). World Health Organization

World Health Organization. (2014a). Action plan for healthy newborn infants in the Western Pacific Region (2014-2020). Manila: WHO Regional Office for the Western Pacific.

WHO Recommendations on Postnatal Care of the Mother and Newborn. Geneva: World Health Organization; 2013 Oct. Available from http://www.ncbi.nlm.nih.gov/books/NBK190086/

World Health Organization. (2017). WHO recommendations on newborn health: guidelines approved by the WHO Guidelines Review Committee (No. WHO/MCA/17.07). World Health Organization

World Health Organization. (2021). Indicators for assessing infant and young child feeding practices: definitions and measurement methods. World Health Organization.

Citations Reporting on Results

Su Weiti (2016). To investigate the relationship between immediate postpartum skin-to-skin contact between mothers and infants, neonatal body temperature and maternal-infant emotional connection [Master's thesis, China Medical University].

Bai DL, Wu KM, Tarrant M. Association between intrapartum interventions and breastfeeding duration. J Midwifery Womens Health. 2013 Jan-Feb;58(1):25-32. doi: 10.1111/j.1542-2011.2012.00254.x. Epub 2013 Jan 14.

Boelig RC, Manuck T, Oliver EA, Di Mascio D, Saccone G, Bellussi F, Berghella V. Labor and delivery guidance for COVID-19. Am J Obstet Gynecol MFM. 2020 May;2(2):100110. doi: 10.1016/j.ajogmf.2020.100110. Epub 2020 Mar 25.

Brown A, Jordan S. Active management of the third stage of labor may reduce breastfeeding duration due to pain and physical complications. Breastfeed Med. 2014 Dec;9(10):494-502. doi: 10.1089/bfm.2014.0048.

Chang PC, Li SF, Yang HY, Wang LC, Weng CY, Chen KF, Chen W, Fan SY. Factors associated with cessation of exclusive breastfeeding at 1 and 2 months postpartum in Taiwan. Int Breastfeed J. 2019 May 7;14:18. doi: 10.1186/s13006-019-0213-1. eCollection 2019.

Duryea EL, Nelson DB, Wyckoff MH, Grant EN, Tao W, Sadana N, Chalak LF, McIntire DD, Leveno KJ. The impact of ambient operating room temperature on neonatal and maternal hypothermia and associated morbidities: a randomized controlled trial. Am J Obstet Gynecol. 2016 Apr;214(4):505.e1-505.e7. doi: 10.1016/j.ajog.2016.01.190. Epub 2016 Feb 10.

Thomi M, Pfammatter JP, Spichiger E. Parental emotional and hands-on work-Experiences of parents with a newborn undergoing congenital heart surgery: A qualitative study. J Spec Pediatr Nurs. 2019 Oct;24(4):e12269. doi: 10.1111/jspn.12269. Epub 2019 Aug 30.

Jia YS, Lin ZL, Lv H, Li YM, Green R, Lin J. Effect of delivery room temperature on the admission temperature of premature infants: a randomized controlled trial. J Perinatol. 2013 Apr;33(4):264-7. doi: 10.1038/jp.2012.100. Epub 2012 Aug 2.

Lee CC, Chiou ST, Chen LC, Chien LY. Breastfeeding-Friendly Environmental Factors and Continuing Breastfeeding Until 6 Months Postpartum: 2008-2011 National Surveys in Taiwan. Birth. 2015 Sep;42(3):242-8. doi: 10.1111/birt.12170. Epub 2015 Jun 22.

Phillips, K., DePue, L., & Mullen, S. (2020). The effect of postpartum fatigue on exclusive breastfeeding rates at discharge: A comparison of birth methods. Journal of Comprehensive Nursing Research and Care, 5(1), 1-5.

Rubagumya, D., Abeid, M., Aghan, E., & Noorani, M. (2021). Barriers to early initiation of breastfeeding in healthy neonates in an urban hospital setting. medRxiv.

Wakamura, T., & Tokura, H. (2002). Circadian rhythm of rectal temperature in humans under different ambient temperature cycles. Journal of thermal biology, 27(5), 439-447.

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