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Cleanser Versus Only Water

NCT ID: NCT04720989

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-09-30

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.

Conditions

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Premature Birth

Keywords

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Skin Barrier Function First Bathing Baby Cleanser Transepidermal Water Loss Skin pH

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bathing With Baby Cleanser

Skin cleansing products will be used in the first baths of the participants in this group.

Group Type EXPERIMENTAL

Bathing With Baby Cleanser and water

Intervention Type PROCEDURE

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

Only water will be used in the first baths of the participants in this group.

Group Type EXPERIMENTAL

Bathing With only Water

Intervention Type PROCEDURE

Preterm infants will have their first baths only with water.

Interventions

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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.

Intervention Type PROCEDURE

Bathing With only Water

Preterm infants will have their first baths only with water.

Intervention Type PROCEDURE

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
Minimum Eligible Age

34 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Halil Ibrahim Tasdemir

Research Assistant, Doctoral Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emine EFE

Role: PRINCIPAL_INVESTIGATOR

http://hemsirelik.akdeniz.edu.tr/iletisim/

Locations

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Akdeniz Universty

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KAEK-929

Identifier Type: -

Identifier Source: org_study_id