Cleanser Versus Only Water

• Sponsor: Akdeniz University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04720989
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.9
• Patients Per Site Per Month: 13.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Birth	Procedure: Bathing With Baby Cleanser and water; Procedure: Bathing With only Water	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: Dec 1, 2021
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Aug 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Transepidermal Water Loss [Change from Baseline (10 minutes before first bathing) Transepidermal Water Loss at 10 minutes and 30 minutes after bathing.]

   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

1. Skin pH Level [Change from Baseline (10 minutes before first bathing) skin pH at 10 minutes and 30 minutes after bathing.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 34 Weeks to 42 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Akdeniz Universty	Antalya		Turkey	07000

Sponsors and Collaborators

• Akdeniz University

Investigators

• Principal Investigator: Emine EFE, http://hemsirelik.akdeniz.edu.tr/iletisim/

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Halil Ibrahim Tasdemir, Research Assistant, Doctoral Candidate, Akdeniz University
• ClinicalTrials.gov Identifier: NCT04720989
• Other Study ID Numbers: KAEK-929
• First Posted: Jan 22, 2021
• Last Update Posted: Jul 21, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Halil Ibrahim Tasdemir, Research Assistant, Doctoral Candidate, Akdeniz University: Skin Barrier Function; First Bathing; Baby Cleanser; Transepidermal Water Loss; Skin pH
• Additional relevant MeSH terms: Premature Birth

Study Results

No Results Posted as of Jul 21, 2022