Delaying First Bathing and Skin Barrier Function on Infant (TEWL)

September 30, 2022 updated by: Halil Ibrahim Tasdemir, Akdeniz University

The Effect of Delayed First Bathing on Skin Barrier Function, Body Temperature and Comfort in Late Preterm Infants

It is still unknown when the first bath should be done in premature newborns. Investigators think that delaying the time of the first bath compared to the time in the clinic will show some positive changes in preterm newborns.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bath procedures and timing to reduce neonatal stress and protect the skin barrier should be preferred. This study aims to investigate the effect of delaying the first bath on skin barrier function, comfort and body temperature in late preterm infants. The study, between March 2020 and March 2021 in Turkey / Antalya will be held in three central provinces in the Neonatal Intensive Care Unit. Skincare is routinely performed between 08.00 and 09.00 in the form of a tub bath. This study sampled 80 stable, late preterm infants who were cared for in the NICU. This example was considered to be sufficient based on a sample size calculation in PS Power and Sample Size Calculations (Version 3.0). Allocations about the allocation were provided only by the lead researcher. Participants were given a sequential number placed in an opaque, closed envelope by the researcher who received the signed parental informed consent. When the participant is planned to take a bath, the researcher will be blind. The researcher who will apply the bathing process will not know the postnatal age of the baby when bathing. And the outcome evaluation of the participants was blinded. The participants were randomly divided into two groups. The bath will be applied to one group within the first 48 hours and the other group within 48-72 hours. The participants will then be placed in a preheated incubator that varies according to the weight and age of the participant. To compensate for such differences, the heads of all participants will be placed at a height of 30 degrees in the right lateral position after bathing. After the bath, participants were left without intervention or contact for about 10 minutes or until they settled before being evaluated. The participant Baths Work Record, a data collection tool, was designed specifically for this study. The instrument includes a series of scales for measuring outcome variables and demographic information (age, sex, mode of delivery, gestational age, birth weight, bodyweight at work, etc.). Outcome measurements include transepidermal water loss for skin barrier function, neonatal comfort behavior, and body temperature. Those responsible for data collection will be blinded in the allocation of the participants they evaluate. The ComfortNeo scale will be used to measure the comfort and pain intensity of newborns. The outcome criteria will be evaluated in three separate cases (10 minutes before bath, 1 minute and 10 minutes after bath). SPSS 20.0 and SAS (ver. 9.3) will be used and statistical significance will be set to p <0.05.

The data will be presented as means and standard deviations for continuous variables and as frequencies for categorical variables. For participant characteristics such as birth type and gender, the chi-square test will be used to determine whether there is a significant difference between the groups. Participant characteristics such as birth weight and body weight during the study will be evaluated for significant intergroup differences using a one-way ANOVA test. In order to compare different phases, the measurement parameters (comfort score, body temperature) in the baths will be averaged separately. To analyze both intra-group and intra-group differences, repeated variance analysis followed by Bonferroni's post hoc test.

Study Type

Interventional

Enrollment (Actual)

80

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

  • Turkey
      • Antalya, Turkey, 07000
        • Akdeniz Universty

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

1 day to 3 days (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Born between 34 weeks + 0 days and 36 weeks + 6 days (late preterms),
  • With a body weight of over 2000g,
  • Spontaneous breathing,
  • Preterms with stable physiological parameters

Exclusion Criteria:

  • Receiving mechanical ventilation support,
  • HIV, Hepatitis B mother baby,
  • Preterms bathed before the intervention,
  • Surgical procedure and incision in any region,
  • Preterms with central catheters,
  • Preterms with systemic infection,
  • Preterms using sedative and / or muscle relaxants,
  • Preterms with congenital, chromosomal abnormalities

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bathing within 24-48
Participants who will have their first bath in 24-48th hours after birth.
Procedure: Bathing
Traditionally, it is the process of washing the newborn in the first hours of life to remove blood, meconium, varnish and other infectious substances.
Experimental: Bathing within 48-72
Participants who will have their first bath in 48-72th hours after birth.
Procedure: Bathing
Traditionally, it is the process of washing the newborn in the first hours of life to remove blood, meconium, varnish and other infectious substances.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Barrier Function
Time Frame: The Skin Barrier Function will be carried out by measuring trans epidermal water loss 10 minutes before first bath and 10 minutes after first bath.
Transepidermal water loss of the participants will be measured using the VapoMeter SWL-2 ™ (Delfin Technologies Ltd). The skin barrier function of the participants will be evaluated in this way.
The Skin Barrier Function will be carried out by measuring trans epidermal water loss 10 minutes before first bath and 10 minutes after first bath.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort
Time Frame: The comfort will be carried out by ComfortNeo scale 10 minutes before first bath, 1 minutes after first bath and 10 minutes after first bath.
The ComfortNeo scale will be used to measure newborns' comfort. The ComfortNeo is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, crying, body movement, facial tension, and (body) muscle tone. The lowest score that can be obtained using this scale is 6, and the highest score is 30. Scores in the range of 6 to 13 indicate that the newborn is comfortable, while scores 14-30 are indicative of pain or distress in the newborn, thus necessitating comforting.
The comfort will be carried out by ComfortNeo scale 10 minutes before first bath, 1 minutes after first bath and 10 minutes after first bath.
Body temperature
Time Frame: The body temperature will be measured by digital thermometers 10 minutes before first bath, 1 minutes after first bath and 10 minutes after first bath.
Axillary body temperature of infants
The body temperature will be measured by digital thermometers 10 minutes before first bath, 1 minutes after first bath and 10 minutes after first bath.

Collaborators and Investigators

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

Sponsor

Akdeniz University

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)

February 20, 2020

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

January 9, 2020

First Submitted That Met QC Criteria

January 15, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 30, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAEK-30

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is not yet decided. After the study was finalized, the decision was planned.

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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