PrematureTEWLNCT04231799
Delaying First Bathing and Skin Barrier Function on Infant
A study testing Bathing in people with Premature and Thermoregulation, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
It is still unknown when the first bath should be done in premature newborns. Investigators think that delaying the time of the first bath compared to the time in the clinic will show some positive changes in preterm newborns. Read more about this study
- Who is it for?
- Ages 24 to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Premature, Thermoregulation
- What is being tested?
- Bathing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2020to 1 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 24 to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born between 34 weeks + 0 days and 36 weeks + 6 days (late preterms),
- With a body weight of over 2000g,
- Spontaneous breathing,
- Preterms with stable physiological parameters
Who cannot join
- Receiving mechanical ventilation support,
- HIV, Hepatitis B mother baby,
- Preterms bathed before the intervention,
- Surgical procedure and incision in any region,
- Preterms with central catheters,
- Preterms with systemic infection,
- Preterms using sedative and / or muscle relaxants,
- Preterms with congenital, chromosomal abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Delayed First Bathing on Skin Barrier Function, Body Temperature and Comfort in Late Preterm Infants
It is still unknown when the first bath should be done in premature newborns. Investigators think that delaying the time of the first bath compared to the time in the clinic will show some positive changes in preterm newborns.
Read the detailed description
Bath procedures and timing to reduce neonatal stress and protect the skin barrier should be preferred. This study aims to investigate the effect of delaying the first bath on skin barrier function, comfort and body temperature in late preterm infants. The study, between March 2020 and March 2021 in Turkey / Antalya will be held in three central provinces in the Neonatal Intensive Care Unit. Skincare is routinely performed between 08.00 and 09.00 in the form of a tub bath. This study sampled 80 stable, late preterm infants who were cared for in the NICU. This example was considered to be sufficient based on a sample size calculation in PS Power and Sample Size Calculations (Version 3.0). Allocations about the allocation were provided only by the lead researcher. Participants were given a sequential number placed in an opaque, closed envelope by the researcher who received the signed parental informed consent. When the participant is planned to take a bath, the researcher will be blind. The researcher who will apply the bathing process will not know the postnatal age of the baby when bathing. And the outcome evaluation of the participants was blinded. The participants were randomly divided into two groups. The bath will be applied to one group within the first 48 hours and the other group within 48-72 hours. The participants will then be placed in a preheated incubator that varies according to the weight and age of the participant. To compensate for such differences, the heads of all participants will be placed at a height of 30 degrees in the right lateral position after bathing. After the bath, participants were left without intervention or contact for about 10 minutes or until they settled before being evaluated. The participant Baths Work Record, a data collection tool, was designed specifically for this study. The instrument includes a series of scales for measuring outcome variables and demographic information (age, sex, mode of delivery, gestational age, birth weight, bodyweight at work, etc.). Outcome measurements include transepidermal water loss for skin barrier function, neonatal comfort behavior, and body temperature. Those responsible for data collection will be blinded in the allocation of the participants they evaluate. The ComfortNeo scale will be used to measure the comfort and pain intensity of newborns. The outcome criteria will be evaluated in three separate cases (10 minutes before bath, 1 minute and 10 minutes after bath). SPSS 20.0 and SAS (ver. 9.3) will be used and statistical significance will be set to p <0.05.
The data will be presented as means and standard deviations for continuous variables and as frequencies for categorical variables. For participant characteristics such as birth type and gender, the chi-square test will be used to determine whether there is a significant difference between the groups. Participant characteristics such as birth weight and body weight during the study will be evaluated for significant intergroup differences using a one-way ANOVA test. In order to compare different phases, the measurement parameters (comfort score, body temperature) in the baths will be averaged separately. To analyze both intra-group and intra-group differences, repeated variance analysis followed by Bonferroni's post hoc test.
- Conditions
- Premature, Thermoregulation
- Being tested
- Bathing
- Keywords
- First Bathing, TEWL, Neonatal intensive care unit, Nursing care, Premature infant, Skin care, Comfort
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BathingProcedure or surgery
Traditionally, it is the process of washing the newborn in the first hours of life to remove blood, meconium, varnish and other infectious substances.
| Study group | Role | What they receive |
|---|---|---|
| Bathing within 24-48 | Experimental | Participants who will have their first bath in 24-48th hours after birth. Receives: Procedure: Bathing |
| Bathing within 48-72 | Experimental | Participants who will have their first bath in 48-72th hours after birth. Receives: Procedure: Bathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Barrier Function
Transepidermal water loss of the participants will be measured using the VapoMeter SWL-2 ™ (Delfin Technologies Ltd). The skin barrier function of the participants will be evaluated in this way.
Measured: The Skin Barrier Function will be carried out by measuring trans epidermal water loss 10 minutes before first bath and 10 minutes after first bath.
Secondary outcomes (2)
Comfort
The ComfortNeo scale will be used to measure newborns' comfort. The ComfortNeo is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, crying, body movement, facial tension, and (body) muscle tone. The lowest score that can be obtained using this scale is 6, and the highest score is 30. Scores in the range of 6 to 13 indicate that the newborn is comfortable, while scores 14-30 are indicative of pain or distress in the newborn, thus necessitating comforting.
Measured: The comfort will be carried out by ComfortNeo scale 10 minutes before first bath, 1 minutes after first bath and 10 minutes after first bath.
Body temperature
Axillary body temperature of infants
Measured: The body temperature will be measured by digital thermometers 10 minutes before first bath, 1 minutes after first bath and 10 minutes after first bath.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start20 Feb 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PrematureStudies 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
- Model description
- Randomized controlled multicenter double blind trial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 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, Study director, Akdeniz University Children's Health and the Nursing Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231799
- Sponsor's protocol ID
- KAEK-30
- Acronym
- TEWL
- Status last verified
- Sep 2022
- First submitted
- 9 Jan 2020
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not yet decided. After the study was finalized, the decision was planned.
Publications
Tasdemir HI, Efe E. The effect of tub bathing and sponge bathing on neonatal comfort and physiological parameters in late preterm infants: A randomized controlled trial. Int J Nurs Stud. 2019 Nov;99:103377. doi: 10.1016/j.ijnurstu.2019.06.008. Epub 2019 Jun 21.
PubMed 31442786Tasdemir HI, Efe E. Effectiveness of Delayed First Baths on Transepidermal Water Loss in Late Preterm Infants: A Randomized Controlled Trial. J Perinat Neonatal Nurs. 2025 Jul-Sep 01;39(3):218-228. doi: 10.1097/JPN.0000000000000878. Epub 2025 Jul 22.
PubMed 39491044Tasdemir HI, Efe E. The effect of delaying first bathing on skin barrier function in late preterm infants: A study protocol for multi-centre, single-blind RCT. J Adv Nurs. 2021 Feb;77(2):1051-1061. doi: 10.1111/jan.14657. Epub 2020 Nov 18.
PubMed 33210328
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Delayed First Bathing on Skin Barrier Function, Body Temperature and Comfort in Late Preterm Infants
- ClinicalTrials.gov ID
- NCT04231799
- Acronym / sponsor ID
- TEWL / KAEK-30
- Conditions
- Premature, Thermoregulation
- Keywords
- First Bathing, TEWL, Neonatal intensive care unit, Nursing care, Premature infant, Skin care, Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 18 Jan 2020 (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.
It is still unknown when the first bath should be done in premature newborns. Investigators think that delaying the time of the first bath compared to the time in the clinic will show some positive changes in preterm newborns.
Detailed description
Bath procedures and timing to reduce neonatal stress and protect the skin barrier should be preferred. This study aims to investigate the effect of delaying the first bath on skin barrier function, comfort and body temperature in late preterm infants. The study, between March 2020 and March 2021 in Turkey / Antalya will be held in three central provinces in the Neonatal Intensive Care Unit. Skincare is routinely performed between 08.00 and 09.00 in the form of a tub bath. This study sampled 80 stable, late preterm infants who were cared for in the NICU. This example was considered to be sufficient based on a sample size calculation in PS Power and Sample Size Calculations (Version 3.0). Allocations about the allocation were provided only by the lead researcher. Participants were given a sequential number placed in an opaque, closed envelope by the researcher who received the signed parental informed consent. When the participant is planned to take a bath, the researcher will be blind. The researcher who will apply the bathing process will not know the postnatal age of the baby when bathing. And the outcome evaluation of the participants was blinded. The participants were randomly divided into two groups. The bath will be applied to one group within the first 48 hours and the other group within 48-72 hours. The participants will then be placed in a preheated incubator that varies according to the weight and age of the participant. To compensate for such differences, the heads of all participants will be placed at a height of 30 degrees in the right lateral position after bathing. After the bath, participants were left without intervention or contact for about 10 minutes or until they settled before being evaluated. The participant Baths Work Record, a data collection tool, was designed specifically for this study. The instrument includes a series of scales for measuring outcome variables and demographic information (age, sex, mode of delivery, gestational age, birth weight, bodyweight at work, etc.). Outcome measurements include transepidermal water loss for skin barrier function, neonatal comfort behavior, and body temperature. Those responsible for data collection will be blinded in the allocation of the participants they evaluate. The ComfortNeo scale will be used to measure the comfort and pain intensity of newborns. The outcome criteria will be evaluated in three separate cases (10 minutes before bath, 1 minute and 10 minutes after bath). SPSS 20.0 and SAS (ver. 9.3) will be used and statistical significance will be set to p <0.05.
The data will be presented as means and standard deviations for continuous variables and as frequencies for categorical variables. For participant characteristics such as birth type and gender, the chi-square test will be used to determine whether there is a significant difference between the groups. Participant characteristics such as birth weight and body weight during the study will be evaluated for significant intergroup differences using a one-way ANOVA test. In order to compare different phases, the measurement parameters (comfort score, body temperature) in the baths will be averaged separately. To analyze both intra-group and intra-group differences, repeated variance analysis followed by Bonferroni's post hoc test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled multicenter double blind trial
| Arm | Type | Receives |
|---|---|---|
| Bathing within 24-48 | Experimental | Procedure: BathingParticipants who will have their first bath in 24-48th hours after birth. |
| Bathing within 48-72 | Experimental | Procedure: BathingParticipants who will have their first bath in 48-72th hours after birth. |
Who may qualify
- Ages
- 24 to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Born between 34 weeks + 0 days and 36 weeks + 6 days (late preterms),
- With a body weight of over 2000g,
- Spontaneous breathing,
- Preterms with stable physiological parameters
Key exclusion criteria (8 listed)
- Receiving mechanical ventilation support,
- HIV, Hepatitis B mother baby,
- Preterms bathed before the intervention,
- Surgical procedure and incision in any region,
- Preterms with central catheters,
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 |
|---|---|---|
| BathingTraditionally, it is the process of washing the newborn in the first hours of life to remove blood, meconium, varnish and other infectious substances. | Procedure or surgery | Bathing within 24-48, Bathing within 48-72 |
Primary outcome
Skin Barrier Function
Time frame: The Skin Barrier Function will be carried out by measuring trans epidermal water loss 10 minutes before first bath and 10 minutes after first bath.
Transepidermal water loss of the participants will be measured using the VapoMeter SWL-2 ™ (Delfin Technologies Ltd). The skin barrier function of the participants will be evaluated in this way.
2 secondary outcomes
Comfort
Time frame: The comfort will be carried out by ComfortNeo scale 10 minutes before first bath, 1 minutes after first bath and 10 minutes after first bath.
Body temperature
Time frame: The body temperature will be measured by digital thermometers 10 minutes before first bath, 1 minutes after first bath and 10 minutes after first bath.
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 3 Oct 2022.
- Background: PubMed 31442786Tasdemir HI, Efe E. The effect of tub bathing and sponge bathing on neonatal comfort and physiological parameters in late preterm infants: A randomized controlled trial. Int J Nurs Stud. 2019 Nov;99:103377. doi: 10.1016/j.ijnurstu.2019.06.008. Epub 2019 Jun 21.
- Derived from this study: PubMed 39491044Tasdemir HI, Efe E. Effectiveness of Delayed First Baths on Transepidermal Water Loss in Late Preterm Infants: A Randomized Controlled Trial. J Perinat Neonatal Nurs. 2025 Jul-Sep 01;39(3):218-228. doi: 10.1097/JPN.0000000000000878. Epub 2025 Jul 22.
- Derived from this study: PubMed 33210328Tasdemir HI, Efe E. The effect of delaying first bathing on skin barrier function in late preterm infants: A study protocol for multi-centre, single-blind RCT. J Adv Nurs. 2021 Feb;77(2):1051-1061. doi: 10.1111/jan.14657. Epub 2020 Nov 18.
- Individual participant dataSharing planned: No. It is not yet decided. After the study was finalized, the decision was planned.
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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 study director
Akdeniz University Children's Health and the Nursing Department
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 in people with Premature and Thermoregulation, 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 3 Oct 2022. 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?
Skin Barrier Function (time frame: The Skin Barrier Function will be carried out by measuring trans epidermal water loss 10 minutes before first bath and 10 minutes after first bath.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04231799, which also lists 3 linked publications.
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 3 Oct 2022.