Cleanser Versus Only Water

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Premature Birth

Intervention / Treatment
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* Procedure: Bathing With Baby Cleanser and water
* Procedure: Bathing With only Water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 34 Weeks
Maximum Age: 42 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bathing With Baby Cleanser<br>Skin cleansing products will be used in the first baths of the participants in this group. | Procedure: Bathing With Baby Cleanser and water<br>* 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.<br>|
| Experimental: Bathing With only Water<br>Only water will be used in the first baths of the participants in this group. | Procedure: Bathing With only Water<br>* Preterm infants will have their first baths only with water.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin Barrier Function, First Bathing, Baby Cleanser, Skin pH, Transepidermal Water Loss