Cleanser Versus Only Water

Not Applicable

Completed

• Conditions: Premature Birth
• Interventions: Procedure: Bathing With only Water; Procedure: Bathing With Baby Cleanser and water

• Registration Number: NCT04720989
• Lead Sponsor: Akdeniz University

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.

Study Timeline

• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-22
• Study Start: 2021-09-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-09-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-25
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bathing With only Water	Bathing With only Water	Only water will be used in the first baths of the participants in this group.
Bathing With Baby Cleanser	Bathing With Baby Cleanser and water	Skin cleansing products will be used in the first baths of the participants in this group.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Akdeniz Universty; 🇹🇷 Antalya, Turkey