Cleanser Versus Only Water

NCT04720989 | Completed DMC

• 1 other identifier: KAEK-929
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Skin pH Level

  Change from Baseline (10 minutes before first bathing) skin pH at 10 minutes and 30 minutes after bathing.

Study Arms (2)

Bathing With Baby Cleanser

EXPERIMENTAL

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

Procedure: Bathing With Baby Cleanser and water

Bathing With only Water

EXPERIMENTAL

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

Procedure: Bathing With only Water

Interventions

Bathing With Baby Cleanser and water 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 Baby Cleanser

Bathing With only Water PROCEDURE

Preterm infants will have their first baths only with water.

Bathing With only Water

Eligibility Criteria

• Age: 34 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz Universty

Antalya, 07000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Baths; Water

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Balneology; Therapeutics; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Emine EFE

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Doctoral Candidate

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 22, 2021
• Study Start: September 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: September 30, 2022
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)