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

June 16, 2022 updated by: Di-Ling Huang, Cardinal Tien Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 235
        • DiLing Huang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: delayed first bath time
Delay first bath to 8 hours after birth
Behavioral: Delay first bath
Newborns delay first bath to 8 hours after birth
No Intervention: regular bath
Birth temperature 36.5°C, regular bath

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
temperature measurement : 10 minutes after bathing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exclusive breastfeeding rate
Time Frame: 3 to 5 days
Neonatal feeding methods during hospitalization
3 to 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardinal Tien Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2021

Primary Completion (Actual)

January 25, 2022

Study Completion (Actual)

January 25, 2022

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

June 21, 2022

Last Update Submitted That Met QC Criteria

June 16, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHuang-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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