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

Not Applicable

Completed

• Conditions: Newborn Hypothermia
• Interventions: Behavioral: Delay first bath

• Registration Number: NCT05425394
• Lead Sponsor: Cardinal Tien Hospital

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.

Study Timeline

• Study Start: 2021-09-02
• Primary Completion: 2022-01-25
• Study Completion: 2022-01-25
• Status Verified: 2022-06
• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-06-16
• Last Update Submitted: 2022-06-16
• Study First Posted: 2022-06-21
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
delayed first bath time	Delay first bath	Delay first bath to 8 hours after birth

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Exclusive breastfeeding rate	3 to 5 days	Neonatal feeding methods during hospitalization

Trial Locations

Locations (1)

DiLing Huang; 🇨🇳 New Taipei City, Taiwan