Clinical trial NCT05425394: A Study of Effects of Delay in the First Bathing Time of Body Temperature and the Rate of Exclusive Breastfeeding
Official title: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn Hypothermia
Keywords: delayed bathing
body temperature
breastfeeding
Lead sponsor: Cardinal Tien Hospital
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: body temperature after bath
timeFrame: temperature measurement : 10 minutes after bathing
Secondary outcomes:
measure: Exclusive breastfeeding rate
timeFrame: 3 to 5 days
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: DiLing Huang
Study officials:
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