Cleanser Versus Only Water
Primary Purpose
Premature Birth
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bathing With Baby Cleanser and water
Bathing With only Water
Sponsored by

About this trial
This is an interventional supportive care trial for Premature Birth focused on measuring Skin Barrier Function, First Bathing, Baby Cleanser, Transepidermal Water Loss, Skin pH
Eligibility Criteria
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
Sites / Locations
- Akdeniz Universty
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bathing With Baby Cleanser
Bathing With only Water
Arm Description
Skin cleansing products will be used in the first baths of the participants in this group.
Only water will be used in the first baths of the participants in this group.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04720989
Brief Title
Cleanser Versus Only Water
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
Skin Barrier Function, First Bathing, Baby Cleanser, Transepidermal Water Loss, Skin pH
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bathing With Baby Cleanser
Arm Type
Experimental
Arm Description
Skin cleansing products will be used in the first baths of the participants in this group.
Arm Title
Bathing With only Water
Arm Type
Experimental
Arm Description
Only water will be used in the first baths of the participants in this group.
Intervention Type
Procedure
Intervention Name(s)
Bathing With Baby Cleanser and water
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bathing With only Water
Intervention Description
Preterm infants will have their first baths only with water.
Primary Outcome Measure Information:
Title
Transepidermal Water Loss
Description
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).
Time Frame
Change from Baseline (10 minutes before first bathing) Transepidermal Water Loss at 10 minutes and 30 minutes after bathing.
Secondary Outcome Measure Information:
Title
Skin pH Level
Description
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.
Time Frame
Change from Baseline (10 minutes before first bathing) skin pH at 10 minutes and 30 minutes after bathing.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
34 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine EFE
Organizational Affiliation
http://hemsirelik.akdeniz.edu.tr/iletisim/
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akdeniz Universty
City
Antalya
ZIP/Postal Code
07000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
If he/she wishes, he/she can be contacted after the broadcast stage.(eril)
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Cleanser Versus Only Water
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