Newborn JaundiceNCT06209489
White Cover and Massage Impact on Bilirubin Levels and Phototherapy Duration in Newborns
A study testing White cover in people with Newborn Jaundice and Hyperbilirubinemia, Neonatal, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to examine the effect of white cover and massage application on newborns' bilirubin level and duration of phototherapy in newborns receiving phototherapy. Read more about this study
- Who is it for?
- Ages 12 hours to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Newborn Jaundice, Hyperbilirubinemia, Neonatal, Newborn Massage
- What is being tested?
- White cover
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 30 Jun 2024
- 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 12 hours to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Term babies with gestational age between 37-42 weeks,
- Does not have a respiratory, cardiovascular, gastrointestinal or neurological disorder or syndrome that would prevent or complicate oral feeding,
- Birth weight of 2500 g and above,
- With phototherapy indication,
- Do not have any health problems other than neonatal jaundice detected in the prenatal period,
- Those with a stable health condition,
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- Orally fed,
- No clinical signs of dehydration,
- Do not have any skin problems that would prevent baby massage,
- Newborns with written and verbal informed consent from their families will be included in the study.
Who cannot join
- Premature,
- Those with congenital malformations,
- Those with hyperbilirubinemia requiring exchange transfusion,
- Those with Rh hemolytic disease,
- Having a positive culture test (sepsis),
- Those with glucose-6-phosphate dehydrogenase (G6PD) deficiency,
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- Birth weight below 2500 grams,
- Those who were referred to another center during the research,
- Discharged early,
- Unexpected complications developed during the research,
- Bronze child syndrome occurs during phototherapy,
- Newborns who develop a pathology that will prevent or complicate oral feeding will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of White Cover and Massage Application on Bilirubin Level and Duration of Phototherapy in Newborns Undergoing Phototherapy
This study aimed to examine the effect of white cover and massage application on newborns' bilirubin level and duration of phototherapy in newborns receiving phototherapy.
Read the detailed description
Hyperbilirubinemia is a common problem seen in the neonatal period, characterized by yellow staining of the skin and sclera, causing an increase in total serum bilirubin >5 mg/dl. Neonatal jaundice is seen in 60% of term newborns and 80% of preterm newborns. Hyperbilirubinemia is usually physiological and disappears within a few days. Jaundice may worsen and lead to kernicterus (accumulation of bilirubin in some parts of the brain) or death if pathological hyperbilirubinemia occurs. Therefore, every baby with hyperbilirubinemia and high serum bilirubin levels requires serious attention and treatment. The primary treatment for neonatal jaundice is phototherapy. The effectiveness of phototherapy depends on the phototherapy light source, light intensity, distance between the phototherapy light and the newborn, and the body surface area exposed to the light. Phototherapy has potential side effects in newborns such as hyperthermia, dehydration, diarrhea, bronze baby syndrome, and skin burns. For this reason, the use of phototherapy should be minimized and solutions should be found to shorten the duration of phototherapy. To increase the effectiveness of phototherapy treatment, a reflector material can be added to the phototherapy. White fabric, which can be used as a reflector, can reflect scattered phototherapy light. When fabrics made of reflective materials are hung over the phototherapy device, they can capture the light that may scatter from the baby to the environment and reflect the light back to the baby. White fabric may increase irradiance and therefore lead to increased bilirubin conversion.Studies have reported that massage applied before phototherapy is effective in reducing the bilirubin level in babies with hyperbilirubinemia. Bilirubin is eliminated from the body through defecation. Removing bilirubin from the body reduces jaundice. Massage reduces bilirubin levels by increasing the frequency of bowel movements in newborn babies.
- Being tested
- White cover
- Keywords
- Newborn, Phototherapy, White Cover, Massage, Hyperbilirubinemia
- Medical subject headings
- Jaundice, Neonatal, Hyperbilirubinemia, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White coverOther
Also called Newborn massage
- A white cover will be covered over the incubator during phototherapy.
- Baby massage will be applied during phototherapy.
| Study group | Role | What they receive |
|---|---|---|
| İntervention group | Experimental | 1. White fabric will be covered over the incubator for term newborns during phototherapy.
2. During phototherapy, term newborns will receive a baby massage, including facial massage, chest massage, arm massage, abdominal massage and leg massage, twice a day for 15 minutes. Receives: Other: White cover |
| Control group | No intervention | The hospital's clinical routine will be applied to the newborns in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
White cover
A white cover will be covered over the incubator during phototherapy.
Measured: 24 hours
Newborn massage
Baby massage will be applied during phototherapy.
Measured: 2 times 15 minutes at 12 hour intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Mar 2024
- Primary completion29 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn JaundiceStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep ÇİFTCİ DEMİRTAŞ, Karabuk University
- Investigators
- Zeynep ZE ÇİFTCİ DEMİRTAŞ, 1, Principal investigator, midwife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209489
- Sponsor's protocol ID
- E-77192459-050.99-299327
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2023
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of White Cover and Massage Application on Bilirubin Level and Duration of Phototherapy in Newborns Undergoing Phototherapy
- ClinicalTrials.gov ID
- NCT06209489
- Acronym / sponsor ID
- E-77192459-050.99-299327
- Keywords
- Newborn, Phototherapy, White Cover, Massage, Hyperbilirubinemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 29 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 17 Jan 2024 (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.
This study aimed to examine the effect of white cover and massage application on newborns' bilirubin level and duration of phototherapy in newborns receiving phototherapy.
Detailed description
Hyperbilirubinemia is a common problem seen in the neonatal period, characterized by yellow staining of the skin and sclera, causing an increase in total serum bilirubin >5 mg/dl. Neonatal jaundice is seen in 60% of term newborns and 80% of preterm newborns. Hyperbilirubinemia is usually physiological and disappears within a few days. Jaundice may worsen and lead to kernicterus (accumulation of bilirubin in some parts of the brain) or death if pathological hyperbilirubinemia occurs. Therefore, every baby with hyperbilirubinemia and high serum bilirubin levels requires serious attention and treatment. The primary treatment for neonatal jaundice is phototherapy. The effectiveness of phototherapy depends on the phototherapy light source, light intensity, distance between the phototherapy light and the newborn, and the body surface area exposed to the light. Phototherapy has potential side effects in newborns such as hyperthermia, dehydration, diarrhea, bronze baby syndrome, and skin burns. For this reason, the use of phototherapy should be minimized and solutions should be found to shorten the duration of phototherapy. To increase the effectiveness of phototherapy treatment, a reflector material can be added to the phototherapy. White fabric, which can be used as a reflector, can reflect scattered phototherapy light. When fabrics made of reflective materials are hung over the phototherapy device, they can capture the light that may scatter from the baby to the environment and reflect the light back to the baby. White fabric may increase irradiance and therefore lead to increased bilirubin conversion.Studies have reported that massage applied before phototherapy is effective in reducing the bilirubin level in babies with hyperbilirubinemia. Bilirubin is eliminated from the body through defecation. Removing bilirubin from the body reduces jaundice. Massage reduces bilirubin levels by increasing the frequency of bowel movements in newborn babies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İntervention group | Experimental | Other: White cover1. White fabric will be covered over the incubator for term newborns during phototherapy. 2. During phototherapy, term newborns will receive a baby massage, including facial massage, chest massage, arm massage, abdominal massage and leg massage, twice a day for 15 minutes. |
| Control group | No intervention | –The hospital's clinical routine will be applied to the newborns in the control group. |
Who may qualify
- Ages
- 12 hours to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Term babies with gestational age between 37-42 weeks,
- Does not have a respiratory, cardiovascular, gastrointestinal or neurological disorder or syndrome that would prevent or complicate oral feeding,
- Birth weight of 2500 g and above,
- With phototherapy indication,
- Do not have any health problems other than neonatal jaundice detected in the prenatal period,
Key exclusion criteria (12 listed)
- Premature,
- Those with congenital malformations,
- Those with hyperbilirubinemia requiring exchange transfusion,
- Those with Rh hemolytic disease,
- Having a positive culture test (sepsis),
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 |
|---|---|---|
| White coverAlso: Newborn massage* A white cover will be covered over the incubator during phototherapy. * Baby massage will be applied during phototherapy. | Other | İntervention group |
Primary outcome
White cover
Time frame: 24 hours
A white cover will be covered over the incubator during phototherapy.
Newborn massage
Time frame: 2 times 15 minutes at 12 hour intervals
Baby massage will be applied during phototherapy.
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 8 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Zeynep ZE ÇİFTCİ DEMİRTAŞ, 1 principal investigator
midwife
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White cover in people with Newborn Jaundice and Hyperbilirubinemia, Neonatal, run by Karabuk 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 10 inclusion and 12 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 8 Jan 2026. 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?
White cover (time frame: 24 hours). The study lists 2 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 8 Jan 2026.