Newborn JaundiceNCT06921330
White Cover & Massage Effects on Bilirubin and Phototherapy in ABO-Incompatible Newborns
A study testing white cover-newborn massage in people with Newborn Jaundice and Hyperbilirubinemia, Neonatal, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the effect of white cover and massage application on bilirubin levels and phototherapy duration in newborns with ABO incompatibility 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, ABO Incompatibility
- What is being tested?
- white cover-newborn massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 4 Apr 2026
- 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
- Abo-Incompatibility term babies with a 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.
Turkey (Türkiye)1 site
Karabük Eğitim Ve Araştırma Hastanesi
Karabük, Karabük Province, 78020
About this study
Official title: The Effect of White Cover and Massage Application on Bilirubin Levels and Duration of Phototherapy in Newborns With ABO Incompatibility Receiving Phototherapy
This study aims to examine the effect of white cover and massage application on bilirubin levels and phototherapy duration in newborns with ABO incompatibility 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 observed in 60% of term newborns and 80% of preterm newborns. Hyperbilirubinemia is usually physiologic and disappears within a few days. If jaundice becomes severe and pathologic hyperbilirubinemia occurs, it can lead to kernicterus (bilirubin accumulation in parts of the brain) or death.Therefore, any infant with hyperbilirubinemia with elevated serum bilirubin levels requires serious attention and treatment.
ABO incompatibility is a cause of indirect hyperbilirubinemia leading to pathologic jaundice. Newborns with ABO incompatibility tend to have higher bilirubin levels due to impaired bilirubin excretion during the neonatal period. ABO incompatibility is observed in approximately 25% of mother-infant pairs. ABO incompatibility may develop when the mother's blood type is O and the baby's blood type is A or B. In ABO incompatibility, maternal anti-A or anti-B antibodies cross the placenta and bind to A/B antigens on the surface of fetal erythrocytes. Antibody-coated erythrocytes are destroyed in the reticuloendothelial system. Bilirubin increases as a result of heme catabolism that is released with the destruction of erythrocytes, and this is reflected in the clinic as neonatal jaundice. In the presence of ABO incompatibility, early screening and close follow-up of newborns in terms of development of hyperbilirubinemia is very important. Traditional treatment modalities for jaundice due to ABO incompatibility are phototherapy and exchange transfusion.
The primary treatment of neonatal jaundice is phototherapy. The efficacy of phototherapy depends on the phototherapy light source, light intensity, the distance between the phototherapy light and the newborn, and the body surface area exposed to light. Phototherapy has potential side effects such as hyperthermia, dehydration, diarrhea, bronze baby syndrome and skin burns in newborns. Therefore, 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 reflective material can be added to the phototherapy. White fabric that can be used as a reflector can reflect the scattered phototherapy light. When fabrics made of reflective materials are hung on the phototherapy device, they can capture light that may be scattered from the baby to the environment and reflect the light back to the baby. The white fabric can increase the irradiance and thus increase bilirubin conversion. Bilirubin is excreted from the body through feces. Removal of bilirubin from the body reduces jaundice. Massage decreases bilirubin levels by increasing the frequency of bowel movements in newborn babies.
- Conditions
- Newborn Jaundice, Hyperbilirubinemia, Neonatal, ABO Incompatibility, Newborn Massage, Phototherapy, White Cover
- Being tested
- white cover-newborn massage
- Keywords
- ABO incompatibility, 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 cover-newborn massageOther
Also called white cover and 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 |
|---|---|---|
| intervention group | Experimental | 1. During phototherapy, the phototherapy devices of term newborns with abo incompatibility will be covered with white cover.
2. During phototherapy, infant massage including facial massage, chest massage, arm massage, abdominal massage and leg massage will be applied to term newborns twice a day for 15 minutes each session with an interval of 6 hours. Receives: Other: white cover-newborn massage |
| 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.
Change in bilirubin level
Capillary bilirubin levels will be measured immediately before the initiation of phototherapy and immediately after the termination of phototherapy. The change in capillary bilirubin levels will be calculated and reported.The unit of measure for bilirubin levels will be milligrams per deciliter (mg/dL).
Measured: From immediately before initiation of phototherapy to immediately after termination of phototherapy
Duration of phototherapy
The total duration of phototherapy required until bilirubin levels decreased below the treatment threshold will be recorded.The unit of measure for the duration of phototherapy is hours.
Measured: From initiation to termination of phototherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Nov 2025
- Primary completion1 Apr 2026
- Study completion4 Apr 2026
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
- NCT06921330
- Sponsor's protocol ID
- E-77192459-050.99-382574
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2025
- Last updated
- 9 Apr 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 9 Apr 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 Levels and Duration of Phototherapy in Newborns With ABO Incompatibility Receiving Phototherapy
- ClinicalTrials.gov ID
- NCT06921330
- Acronym / sponsor ID
- E-77192459-050.99-382574
- Conditions
- Newborn Jaundice, Hyperbilirubinemia, Neonatal, ABO Incompatibility, Newborn Massage, Phototherapy, White Cover
- Keywords
- ABO incompatibility, 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 Nov 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 4 Apr 2026 (actual)
- First posted
- 10 Apr 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.
This study aims to examine the effect of white cover and massage application on bilirubin levels and phototherapy duration in newborns with ABO incompatibility 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 observed in 60% of term newborns and 80% of preterm newborns. Hyperbilirubinemia is usually physiologic and disappears within a few days. If jaundice becomes severe and pathologic hyperbilirubinemia occurs, it can lead to kernicterus (bilirubin accumulation in parts of the brain) or death.Therefore, any infant with hyperbilirubinemia with elevated serum bilirubin levels requires serious attention and treatment.
ABO incompatibility is a cause of indirect hyperbilirubinemia leading to pathologic jaundice. Newborns with ABO incompatibility tend to have higher bilirubin levels due to impaired bilirubin excretion during the neonatal period. ABO incompatibility is observed in approximately 25% of mother-infant pairs. ABO incompatibility may develop when the mother's blood type is O and the baby's blood type is A or B. In ABO incompatibility, maternal anti-A or anti-B antibodies cross the placenta and bind to A/B antigens on the surface of fetal erythrocytes. Antibody-coated erythrocytes are destroyed in the reticuloendothelial system. Bilirubin increases as a result of heme catabolism that is released with the destruction of erythrocytes, and this is reflected in the clinic as neonatal jaundice. In the presence of ABO incompatibility, early screening and close follow-up of newborns in terms of development of hyperbilirubinemia is very important. Traditional treatment modalities for jaundice due to ABO incompatibility are phototherapy and exchange transfusion.
The primary treatment of neonatal jaundice is phototherapy. The efficacy of phototherapy depends on the phototherapy light source, light intensity, the distance between the phototherapy light and the newborn, and the body surface area exposed to light. Phototherapy has potential side effects such as hyperthermia, dehydration, diarrhea, bronze baby syndrome and skin burns in newborns. Therefore, 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 reflective material can be added to the phototherapy. White fabric that can be used as a reflector can reflect the scattered phototherapy light. When fabrics made of reflective materials are hung on the phototherapy device, they can capture light that may be scattered from the baby to the environment and reflect the light back to the baby. The white fabric can increase the irradiance and thus increase bilirubin conversion. Bilirubin is excreted from the body through feces. Removal of bilirubin from the body reduces jaundice. Massage decreases 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 |
|---|---|---|
| intervention group | Experimental | Other: white cover-newborn massage1. During phototherapy, the phototherapy devices of term newborns with abo incompatibility will be covered with white cover. 2. During phototherapy, infant massage including facial massage, chest massage, arm massage, abdominal massage and leg massage will be applied to term newborns twice a day for 15 minutes each session with an interval of 6 hours. |
| 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)
- Abo-Incompatibility term babies with a 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 cover-newborn massageAlso: white cover and massageA white cover will be covered over the incubator during phototherapy. Baby massage will be applied during phototherapy. | Other | intervention group |
Primary outcome
Change in bilirubin level
Time frame: From immediately before initiation of phototherapy to immediately after termination of phototherapy
Capillary bilirubin levels will be measured immediately before the initiation of phototherapy and immediately after the termination of phototherapy. The change in capillary bilirubin levels will be calculated and reported.The unit of measure for bilirubin levels will be milligrams per deciliter (mg/dL).
Duration of phototherapy
Time frame: From initiation to termination of phototherapy
The total duration of phototherapy required until bilirubin levels decreased below the treatment threshold will be recorded.The unit of measure for the duration of phototherapy is hours.
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 9 Apr 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-newborn massage 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 9 Apr 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?
Change in bilirubin level (time frame: From immediately before initiation of phototherapy to immediately after termination of phototherapy). 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 9 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.