A Study of Effects of Delay in the First Bathing Time of Body Temperature and the Rate of Exclusive Breastfeeding
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2022
CompletedFirst Submitted
Initial submission to the registry
June 7, 2022
CompletedFirst Posted
Study publicly available on registry
June 21, 2022
CompletedJune 21, 2022
June 1, 2022
5 months
June 7, 2022
June 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
body temperature after bath
The degree of decrease in body temperature after bathing compared to before bathing
temperature measurement : 10 minutes after bathing
Secondary Outcomes (1)
Exclusive breastfeeding rate
3 to 5 days
Study Arms (2)
delayed first bath time
EXPERIMENTALDelay first bath to 8 hours after birth
regular bath
NO INTERVENTIONBirth temperature 36.5°C, regular bath
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
DiLing Huang
New Taipei City, 235, Taiwan
Related Publications (79)
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PMID: 32518901RESULTBrown 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.
PMID: 25347567RESULTChang 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.
PMID: 31080493RESULTDuryea 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.
PMID: 26874298RESULTThomi 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.
PMID: 31468697RESULTJia 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.
PMID: 22858889RESULTLee 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.
PMID: 26095672RESULTPhillips, 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.
RESULTRubagumya, D., Abeid, M., Aghan, E., & Noorani, M. (2021). Barriers to early initiation of breastfeeding in healthy neonates in an urban hospital setting. medRxiv.
RESULTWakamura, T., & Tokura, H. (2002). Circadian rhythm of rectal temperature in humans under different ambient temperature cycles. Journal of thermal biology, 27(5), 439-447.
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head nursing
Study Record Dates
First Submitted
June 7, 2022
First Posted
June 21, 2022
Study Start
September 2, 2021
Primary Completion
January 25, 2022
Study Completion
January 25, 2022
Last Updated
June 21, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share
This study is a personal research project, and the subject's instructions and consent form for human trials inform the subjects that the data in the study is for this study only.