Cleanser Versus Only Water

Premature Birth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04720989
• Other study ID #: KAEK-929
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: December 2023
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 30, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 34 Weeks to 42 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

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.
• Bathing With only Water
Preterm infants will have their first baths only with water.

Locations

Country	Name	City	State
Turkey	Akdeniz Universty	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.