Phototherapy Skin RashNCT06819150
Effect of Bathing on Physiological Parameters, Skin, Bilirubin and Comfort Levels in Infants Receiving Phototherapy
A study testing Newborn bathing in people with Phototherapy Skin Rash, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of bathing on physiological parameters (heart rate, body temperature and oxygen saturation), skin, bilirubin and comfort level in infants receiving phototherapy. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Phototherapy Skin Rash
- What is being tested?
- Newborn bathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born at 35-41 gestational weeks
- Indirect hyperbilirubinaemia diagnosed at 24 hours of birth or more,
- No health problems,
- Indication for phototherapy treatment
- Stable vital signs
- Whose parents agreed to participate in the study
Who cannot join
- Newborns with ABO and Rh incompatibility,
- Direct diagnosis of hyperbilirubinaemia,
- Congenital anomaly,
- With skin lesions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kütahya Şehir Hospital
Kütahya, Merkez, 43050
Perihan B Çalışkan, MSc student, +90 506 162 6224 ext. +90 5061626224, perihanbeyza99@gmail.com
Raziye Çelen, Asst. Prof., +90 0332 241 01 10, rturgut42@gmail.com
About this study
The aim of this study is to determine the effect of bathing on physiological parameters (heart rate, body temperature and oxygen saturation), skin, bilirubin and comfort level in infants receiving phototherapy.
Read the detailed description
Neonatal jaundice (hyperbilirubinemia) causes a yellowish discolouration of the sclera and skin due to increased levels of bilirubin in the blood. Jaundice develops in 60% of term babies and 80% of premature babies in the first week of life. Currently, the appropriate treatment option for neonatal jaundice is phototherapy. Phototherapy treatment reduces bilirubin concentrations through various photochemical reactions that allow bilirubin to be excreted more easily. However, phototherapy treatment is associated with short-term side effects including transient skin rashes, diarrhoea, hyperthermia and dehydration.
Physiological reasons such as the weak connection between the epidermis and dermis layer in the skin of the newborn, the pH value of the skin being close to neutral or alkaline, and the low melanosome production increase the susceptibility of the newborn to infection and skin damage. Invasive interventions, use of antiseptics, phototherapy and various instruments may disrupt the skin integrity of the newborn. Therefore, all newborns receiving treatment and care in the neonatal intensive care unit are at risk in terms of skin integrity.
In the majority of newborn infants; jaundice develops, which can affect the newborn neurologically, motor and hearing if left untreated,. Phototherapy devices are widely used today for the treatment of jaundice. Phototherapy devices used in the treatment of jaundice have side effects such as skin rashes, diarrhea, dehydration and hyperthermia. In the literature reviewed, results were found that bathing the newborn reduces phototherapy rashes, lowers the bilirubin level and increases the comfort of the newborn. Also in the literature; There are studies showing that one of the most suitable bathing methods for a newborn is bathtub bathing and that bathing with baby shampoo is not harmful to the newborn.
- Conditions
- Phototherapy Skin Rash
- Being tested
- Newborn bathing
- Keywords
- Phototherapy, Newborn, Bilirubin, Bath, Comfort, Skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Newborn bathingOther
The babies in the experimental group will have a bathtub bath before starting phototherapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| Newborn bathing | Experimental | The term and preterm infants in the experimental group will have a bathtub bath before starting phototherapy treatment. Receives: Other: Newborn bathing |
| Standard of care | No intervention | No intervention other than routine clinical practices will be applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Information Form
The form, prepared by the researchers based on the literature, includes questions containing natal-postnatal information of preterm and term infants (date of birth, gestational week, postnatal age, gender, birth weight, mode of delivery, NICU admission date, initiation time of phototherapy, etc.).
Measured: First measurement-First day of hospitalization
Follow-up form for physiologic parameters - Heart rate
Heart rate will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.
Measured: Heart rate will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
Follow-up form for physiologic parameters -Respiratory rate
Respiratory rate will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.
Measured: Respiratory rate will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
Follow-up form for physiologic parameters- Body temperature
Body temperature will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.
Measured: Body temperature will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
Follow-up form for physiologic parameters- Oxygen saturation
Oxygen saturation will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.
Measured: Oxygen saturation will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
Follow-up form for Skin moisture
Skin moisture will be measured using a device (Digital Moisture Monitor for Skin) on the forehead, abdomen, back, arms (right-left) and legs (right-left).
Measured: Skin moisture will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
Neonatal Skin Condition Score
Neonatal Skin Condition Assessment Scale, will assess the infants' skin condition 10 minutes before treatment/bath (T0) The infants' skin condition will then be reassessed 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after bath or treatment.
Measured: Neonatal Skin Condition Assessment Scale, will assess the infants' skin condition 10 minutes before treatment/bath (T0) The infants' skin condition will then be reassessed 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after bath or treatment.
Bilirubin level
In the experimental and control groups, the total serum bilirubin levels will be evaluated 10 minutes before treatment/bathing (T0). The bilirubin levels will be measured for the second time at 24 hours after the start of phototherapy treatment (T1).
Measured: In the experimental and control groups, the total serum bilirubin levels will be evaluated 10 minutes before treatment/bathing (T0). The bilirubin levels will be measured for the second time at 24 hours after the start of phototherapy treatment (T1).
The comfort level
The Newborn Comfort Behavior Scale (COMFORTneo) will assess the comfort of the newborn. The scale will evaluate the newborn's calmness/agitation, respiratory response, pain, body movements, facial tension, and muscle tone.The scale is scored between 6-30. As the score obtained from the scale increases, it shows that the newborn is uncomfortable and needs practices that will increase their comfort
Measured: The comfort level of the babies in the experimental and control groups will be evaluated 10 minutes before the treatment/bath. The comfort of the babies will be re-evaluated 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the bath or treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 May 2024
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phototherapy Skin RashStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raziye Çelen, Selcuk University
- Investigators
- Perihan B Çalışkan, MSc student, Principal investigator, Selcuk UniversityRaziye Çelen, Asst. Prof., Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819150
- Sponsor's protocol ID
- 2023/78_TR
- Status last verified
- Feb 2025
- First submitted
- 4 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bathing on Physiological Parameters, Skin, Bilirubin and Comfort Levels in Infants Receiving Phototherapy
- ClinicalTrials.gov ID
- NCT06819150
- Acronym / sponsor ID
- 2023/78_TR
- Conditions
- Phototherapy Skin Rash
- Keywords
- Phototherapy, Newborn, Bilirubin, Bath, Comfort, Skin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 11 Feb 2025 (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 bathing on physiological parameters (heart rate, body temperature and oxygen saturation), skin, bilirubin and comfort level in infants receiving phototherapy.
Detailed description
Neonatal jaundice (hyperbilirubinemia) causes a yellowish discolouration of the sclera and skin due to increased levels of bilirubin in the blood. Jaundice develops in 60% of term babies and 80% of premature babies in the first week of life. Currently, the appropriate treatment option for neonatal jaundice is phototherapy. Phototherapy treatment reduces bilirubin concentrations through various photochemical reactions that allow bilirubin to be excreted more easily. However, phototherapy treatment is associated with short-term side effects including transient skin rashes, diarrhoea, hyperthermia and dehydration.
Physiological reasons such as the weak connection between the epidermis and dermis layer in the skin of the newborn, the pH value of the skin being close to neutral or alkaline, and the low melanosome production increase the susceptibility of the newborn to infection and skin damage. Invasive interventions, use of antiseptics, phototherapy and various instruments may disrupt the skin integrity of the newborn. Therefore, all newborns receiving treatment and care in the neonatal intensive care unit are at risk in terms of skin integrity.
In the majority of newborn infants; jaundice develops, which can affect the newborn neurologically, motor and hearing if left untreated,. Phototherapy devices are widely used today for the treatment of jaundice. Phototherapy devices used in the treatment of jaundice have side effects such as skin rashes, diarrhea, dehydration and hyperthermia. In the literature reviewed, results were found that bathing the newborn reduces phototherapy rashes, lowers the bilirubin level and increases the comfort of the newborn. Also in the literature; There are studies showing that one of the most suitable bathing methods for a newborn is bathtub bathing and that bathing with baby shampoo is not harmful to the newborn.
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 |
|---|---|---|
| Newborn bathing | Experimental | Other: Newborn bathingThe term and preterm infants in the experimental group will have a bathtub bath before starting phototherapy treatment. |
| Standard of care | No intervention | –No intervention other than routine clinical practices will be applied to the control group. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Born at 35-41 gestational weeks
- Indirect hyperbilirubinaemia diagnosed at 24 hours of birth or more,
- No health problems,
- Indication for phototherapy treatment
- Stable vital signs
Key exclusion criteria (4 listed)
- Newborns with ABO and Rh incompatibility,
- Direct diagnosis of hyperbilirubinaemia,
- Congenital anomaly,
- With skin lesions
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 |
|---|---|---|
| Newborn bathingThe babies in the experimental group will have a bathtub bath before starting phototherapy treatment. | Other | Newborn bathing |
Primary outcome
Infant Information Form
Time frame: First measurement-First day of hospitalization
The form, prepared by the researchers based on the literature, includes questions containing natal-postnatal information of preterm and term infants (date of birth, gestational week, postnatal age, gender, birth weight, mode of delivery, NICU admission date, initiation time of phototherapy, etc.).
Follow-up form for physiologic parameters - Heart rate
Time frame: Heart rate will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
Heart rate will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.
Follow-up form for physiologic parameters -Respiratory rate
Time frame: Respiratory rate will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
Respiratory rate will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.
Follow-up form for physiologic parameters- Body temperature
Time frame: Body temperature will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
Body temperature will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.
Follow-up form for physiologic parameters- Oxygen saturation
Time frame: Oxygen saturation will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
Oxygen saturation will be measured 10 minutes before the intervention, 30 minutes, 60 minutes and 6 hours after the intervention.
Follow-up form for Skin moisture
Time frame: Skin moisture will be measured 10 minutes before the intervention (T0), 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the intervention.
Skin moisture will be measured using a device (Digital Moisture Monitor for Skin) on the forehead, abdomen, back, arms (right-left) and legs (right-left).
Neonatal Skin Condition Score
Time frame: Neonatal Skin Condition Assessment Scale, will assess the infants' skin condition 10 minutes before treatment/bath (T0) The infants' skin condition will then be reassessed 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after bath or treatment.
Neonatal Skin Condition Assessment Scale, will assess the infants' skin condition 10 minutes before treatment/bath (T0) The infants' skin condition will then be reassessed 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after bath or treatment.
Bilirubin level
Time frame: In the experimental and control groups, the total serum bilirubin levels will be evaluated 10 minutes before treatment/bathing (T0). The bilirubin levels will be measured for the second time at 24 hours after the start of phototherapy treatment (T1).
In the experimental and control groups, the total serum bilirubin levels will be evaluated 10 minutes before treatment/bathing (T0). The bilirubin levels will be measured for the second time at 24 hours after the start of phototherapy treatment (T1).
The comfort level
Time frame: The comfort level of the babies in the experimental and control groups will be evaluated 10 minutes before the treatment/bath. The comfort of the babies will be re-evaluated 30 minutes (T1), 60 minutes (T2) and 6 hours (T3) after the bath or treatment.
The Newborn Comfort Behavior Scale (COMFORTneo) will assess the comfort of the newborn. The scale will evaluate the newborn's calmness/agitation, respiratory response, pain, body movements, facial tension, and muscle tone.The scale is scored between 6-30. As the score obtained from the scale increases, it shows that the newborn is uncomfortable and needs practices that will increase their comfort
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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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.
Perihan B Çalışkan, MSc student principal investigator
Selcuk University
Raziye Çelen, Asst. Prof. principal investigator
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Newborn bathing in people with Phototherapy Skin Rash, run by Selcuk 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Perihan B Çalışkan, MSc student (+90 5061626224 ext. +90 5061626224, perihanbeyza99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Information Form (time frame: First measurement-First day of hospitalization). The study lists 9 primary outcomes in all. 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 11 Feb 2025.