Premature BirthNCT04720989
Cleanser Versus Only Water
A study testing Bathing With Baby Cleanser and water and Bathing With only Water in people with Premature Birth, run by Akdeniz University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 34 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Bathing With Baby Cleanser and water and Bathing With only Water
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Premature Birth
- Being tested
- Bathing With Baby Cleanser and water, Bathing With only Water
- Keywords
- Skin Barrier Function, First Bathing, Baby Cleanser, Transepidermal Water Loss, Skin pH
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bathing With Baby Cleanser and waterProcedure or surgery
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 WaterProcedure or surgery
Preterm infants will have their first baths only with water.
| Study group | Role | What they receive |
|---|---|---|
| Bathing With Baby Cleanser | Experimental | Skin cleansing products will be used in the first baths of the participants in this group. Receives: 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. Receives: Procedure: Bathing With only Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Change from Baseline (10 minutes before first bathing) skin pH at 10 minutes and 30 minutes after bathing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Sep 2021
- Primary completion1 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Ibrahim Tasdemir, Akdeniz University
- Investigators
- Emine EFE, Principal investigator, http://hemsirelik.akdeniz.edu.tr/iletisim/
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720989
- Sponsor's protocol ID
- KAEK-929
- Status last verified
- Dec 2023
- First submitted
- 14 Jan 2021
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If he/she wishes, he/she can be contacted after the broadcast stage.(eril)
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04720989
- Acronym / sponsor ID
- KAEK-929
- Conditions
- Premature Birth
- Keywords
- Skin Barrier Function, First Bathing, Baby Cleanser, Transepidermal Water Loss, Skin pH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bathing With Baby Cleanser | Experimental | Procedure: Bathing With Baby Cleanser and waterSkin cleansing products will be used in the first baths of the participants in this group. |
| Bathing With only Water | Experimental | Procedure: Bathing With only WaterOnly water will be used in the first baths of the participants in this group. |
Who may qualify
- Ages
- 34 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bathing With Baby Cleanser and waterLate 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. | Procedure or surgery | Bathing With Baby Cleanser |
| Bathing With only WaterPreterm infants will have their first baths only with water. | Procedure or surgery | Bathing With only Water |
Primary outcome
Transepidermal Water Loss
Time frame: 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).
1 secondary outcome
Skin pH Level
Time frame: Change from Baseline (10 minutes before first bathing) skin pH at 10 minutes and 30 minutes after bathing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: No. If he/she wishes, he/she can be contacted after the broadcast stage.(eril)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emine EFE principal investigator
http://hemsirelik.akdeniz.edu.tr/iletisim/
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bathing With Baby Cleanser and water and Bathing With only Water in people with Premature Birth, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transepidermal Water Loss (time frame: Change from Baseline (10 minutes before first bathing) Transepidermal Water Loss at 10 minutes and 30 minutes after bathing.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023; AzTrials last refreshed its copy on 27 Oct 2026.