Cleanser Versus Only Water

The Effect of Cleansing Product Used in the First Bathing on Transepidermal Water Loss and Skin Ph in Late Preterm and Term Infants: A Multicenter, Evaluative Blind Randomized Controlled Study

The aim of this study is to determine the effect of the newborn's first bath with a cleaning product and only water on the barrier function of the skin.

Study Overview

• Status: Completed
• Conditions: Premature Birth
• Intervention / Treatment: Procedure: Bathing With Baby Cleanser and water; Procedure: Bathing With only Water

Detailed Description

Studies in the literature on the effects of newborn bath types on the effects of body temperature on newborn crying times, on the effects of newborn behavior and stress, the views and practices of mothers with newborn babies on baby bathing, and the effects of bath types on the umbilical cord in term babies, and the effects of bath products on newborns. It seems that there are studies done. However, although studies on the effect of the cleaning product used in the first bath of late preterm and term newborns on the skin barrier are limited in number for term newborns, there are almost no studies for late preterm newborns. The hypotheses of this study are as follows; 1. In late preterm and term newborns, the first bath with cleaning product protects the newborns' Transepidermal Fluid Loss better than the first bath with only water. 2. In late preterm and term newborns, the first bath with cleansing product keeps the skin pH levels of newborns at a more optimal level compared to the first bath with only water.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 07000
    • Akdeniz Universty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 9 months (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Born between 34 weeks + 0 days and 42 weeks + 6 days (late preterm and term),
• With a body weight of 1800g or more,
• Spontaneous breathing,
• Preterms with stable physiological parameters will be included in the study.

Exclusion Criteria:

• Receiving mechanical ventilation support,
• Mother's baby with HIV, Hepatitis B,
• Preterms who had a bath before the intervention,
• Surgical operation and incision in any area,
• Preterms with a central catheter,
• Preterms with systemic infections,
• Preterms using sedatives and / or muscle relaxants,
• Preterms with congenital or chromosomal anomalies

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bathing With Baby Cleanser; Skin cleansing products will be used in the first baths of the participants in this group.	Procedure: Bathing With Baby Cleanser and water; Late preterm and term newborns, whose informed consents are obtained by their parents to participate in the project, will be given their first baths according to the intervention group they are assigned to. Before the first bath / after birth, preterm newborns in all groups will be wiped only once with a clean towel without removing the vernix caseosa. Newborns who were bathed before the application of the study will be excluded from the study. As the most appropriate time for bath time, 30 minutes after the end of the feeding and treatment of the newborns, the bath application will be made at any time between 9 pm and 3 pm.
Experimental: Bathing With only Water; Only water will be used in the first baths of the participants in this group.	Procedure: Bathing With only Water; Preterm infants will have their first baths only with water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transepidermal Water Loss	Among the outcome criteria, the skin barrier function will be evaluated first. Skin barrier function will be evaluated by measuring Transepidermal Water Loss (TESK). To measure transepidermal water loss, it will be measured by closed chamber evaporation using VapoMeter SWL-2 ™ (Delfin Technologies Ltd).	Change from Baseline (10 minutes before first bathing) Transepidermal Water Loss at 10 minutes and 30 minutes after bathing.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin pH Level	In the secondary outcome measure of the research, results related to the skin pH level will be shown. Skincheck HI 98109 ™ will be used to measure these results.	Change from Baseline (10 minutes before first bathing) skin pH at 10 minutes and 30 minutes after bathing.

Collaborators and Investigators

• Sponsor: Akdeniz University
• Investigators: Principal Investigator: Emine EFE, http://hemsirelik.akdeniz.edu.tr/iletisim/

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 25, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Transepidermal Water Loss; Skin Barrier Function; First Bathing; Baby Cleanser; Skin pH
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: KAEK-929

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: If he/she wishes, he/she can be contacted after the broadcast stage.(eril)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No