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CompletedNCT04720989Updated Dec 27, 2023

Cleanser Versus Only Water

An interventional study of Bathing With Baby Cleanser and water and Bathing With only Water in Premature Birth, sponsored by Akdeniz University. Completed at 1 site in Turkey. Open to participants aged 34 Weeks to 42 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-27.

Sponsored by Akdeniz University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
34 Weeks to 42 Weeks
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Premature Birth

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Keywords

  • Skin Barrier Function
  • First Bathing
  • Baby Cleanser
  • Transepidermal Water Loss
  • Skin pH
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 120 is above the median of 84 across 1,688 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Akdeniz University is the lead sponsor of 289 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
34 Weeks to 42 Weeks
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureBathing 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.

  • ProcedureBathing With only Water

    Preterm infants will have their first baths only with water.

06

What researchers measure

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).

    Time frame: 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

    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.

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

07

Study locations

1 site
  • Akdeniz Universty
    Antalya, 07000, Turkey
08

References and documents

Individual participant data

Plan to share: No — If he/she wishes, he/she can be contacted after the broadcast stage.(eril)

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04720989
Lead sponsor
Akdeniz University
Responsible party
Halil Ibrahim Tasdemir (Research Assistant, Doctoral Candidate, Akdeniz University) — Principal investigator
First posted
Jan 22, 2021
Start date
Sep 1, 2021
Primary completion
Aug 1, 2022
Completion
Sep 30, 2022
Last update
Dec 27, 2023

Study contacts

Emine EFE
principal investigator · http://hemsirelik.akdeniz.edu.tr/iletisim/

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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