PrematureNCT07266246
Effectiveness of Aluminum Foil vs White Linen Reflectors in Phototherapy for Neonatal Hyperbilirubinemia
A study testing reflective material in people with Premature and Phototherapy, run by Kubra Nur Kabakcı Sarıdağ at 1 site in Turkey (Türkiye).
Trial summary
Background: Indirect hyperbilirubinemia (IHB) is a common neonatal condition, affecting over 60% of term and 80% of preterm infants. Phototherapy is the most widely used, safe, and non-invasive treatment; however, scattering of phototherapy light decreases treatment efficacy, prolongs therapy duration, and increases… Read more about this study
- Who is it for?
- Ages 36 to 42 weeks
- Conditions the study is for
- Premature, Phototherapy, Neonatal Intensive Care Unit
- What is being tested?
- reflective material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2024to 1 Dec 2025
- 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 36 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates with total serum bilirubin levels between 15-20 mg/dL
- Gestational age between 35-42 weeks
- Birth weight between 2500-4000 g
- APGAR score of 7-10 at the 1st and 5th minutes after birth
- Fed with breast milk and/or formula
- Written and verbal informed consent obtained from parents
- Neonates who can be reached on the first day of phototherapy treatment
Who cannot join
- Neonates with Rh incompatibility
- Neonates with ABO incompatibility
- Neonates with any congenital anomaly
- Neonates with asphyxia
- Neonates receiving intensive (double) phototherapy
- Neonates with glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Neonates with serum bilirubin levels close to the exchange transfusion threshold
- Neonates whose parents do not consent to participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Background: Indirect hyperbilirubinemia (IHB) is a common neonatal condition, affecting over 60% of term and 80% of preterm infants. Phototherapy is the most widely used, safe, and non-invasive treatment; however, scattering of phototherapy light decreases treatment efficacy, prolongs therapy duration, and increases the risk of side effects. Reflective materials have been suggested to enhance phototherapy effectiveness, yet studies comparing different reflector types remain limited.
Aim: This study aims to compare the effects of using reflective materials (white cloth or aluminum foil) during phototherapy on total serum bilirubin levels and phototherapy duration, in neonates with physiological IHB.
Read more
Methods: This single-center, single-blind, randomized controlled trial will be conducted at Ankara University Faculty of Medicine, Cebeci Neonatal Intensive Care Unit. A total of 81 neonates with gestational age 35-42 weeks and total serum bilirubin levels of 15-20 mg/dl will be randomly assigned into three groups: (1) phototherapy with white cloth reflectors, (2) phototherapy with aluminum foil reflectors, and (3) standard phototherapy (control). Data will be collected using an Introductory Information Form and Daily Follow-up Chart. Statistical analyses will include parametric and non-parametric tests based on distribution assumptions, with significance set at p<0.05.
Expected Results: It is hypothesized that the use of reflective materials will result in faster reduction of total serum bilirubin and shorter phototherapy compared with standard phototherapy.
Conclusion: The study will provide evidence on the comparative effectiveness of two low-cost reflector materials in enhancing phototherapy outcomes, potentially offering a practical and efficient strategy for neonatal hyperbilirubinemia management.
- Conditions
- Premature, Phototherapy, Neonatal Intensive Care Unit, Neonatal Hyperbilirubinemia, Nursing
- Being tested
- reflective material
- Medical subject headings
- Premature Birth, Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reflective materialOther
When receiving phototherapy treatment in groups, reflective materials (aluminum foil-coated sheet or white sheet-covered sheet) were placed in the incubators.
| Study group | Role | What they receive |
|---|---|---|
| Group using a white sheet as reflective material in conjunction with phototherapy | Experimental | The three sides of the incubator will be covered with a cardboard panel, cut to fit the incubator dimensions, lined with white linen cloth on the inner surface (length 88 cm, width 47 cm, height 34 cm). Receives: Other: reflective material |
| Group Using Aluminum Foil as Reflective Material in Combination with Phototherapy | Experimental | The incubators will be enclosed by a panel covered with aluminum foil on three sides (long side 88 cm, short side 47 cm, height 34 cm). Receives: Other: reflective material |
| Group Receiving Standard Single Phototherapy | No intervention | Infants will receive treatment in accordance with standard phototherapy practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Serum Bilirubin Level
The difference in total serum bilirubin concentration measured at baseline (before phototherapy), at the 4th hour, and at the last measurement during phototherapy, expressed in mg/dL.
Measured: At baseline (prior to phototherapy), 4 hours after initiation, and at the final assessment before discontinuation of phototherapy (up to 24 hours)
Duration of Phototherapy
Total duration of phototherapy received by each infant, recorded in hours.
Measured: Measured once at completion of phototherapy (up to 24 hours after initiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start30 Dec 2024
- Primary completion2 Jun 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kubra Nur Kabakcı Sarıdağ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kubra Nur Kabakcı Sarıdağ, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266246
- Sponsor's protocol ID
- KUBRAN
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Aluminum Foil vs White Linen Reflectors in Phototherapy for Neonatal Hyperbilirubinemia
- ClinicalTrials.gov ID
- NCT07266246
- Acronym / sponsor ID
- KUBRAN
- Conditions
- Premature, Phototherapy, Neonatal Intensive Care Unit, Neonatal Hyperbilirubinemia, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Kubra Nur Kabakcı SarıdağUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 5 Dec 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.
Background: Indirect hyperbilirubinemia (IHB) is a common neonatal condition, affecting over 60% of term and 80% of preterm infants. Phototherapy is the most widely used, safe, and non-invasive treatment; however, scattering of phototherapy light decreases treatment efficacy, prolongs therapy duration, and increases the risk of side effects. Reflective materials have been suggested to enhance phototherapy effectiveness, yet studies comparing different reflector types remain limited.
Aim: This study aims to compare the effects of using reflective materials (white cloth or aluminum foil) during phototherapy on total serum bilirubin levels and phototherapy duration, in neonates with physiological IHB.
Methods: This single-center, single-blind, randomized controlled trial will be conducted at Ankara University Faculty of Medicine, Cebeci Neonatal Intensive Care Unit. A total of 81 neonates with gestational age 35-42 weeks and total serum bilirubin levels of 15-20 mg/dl will be randomly assigned into three groups: (1) phototherapy with white cloth reflectors, (2) phototherapy with aluminum foil reflectors, and (3) standard phototherapy (control). Data will be collected using an Introductory Information Form and Daily Follow-up Chart. Statistical analyses will include parametric and non-parametric tests based on distribution assumptions, with significance set at p<0.05.
Expected Results: It is hypothesized that the use of reflective materials will result in faster reduction of total serum bilirubin and shorter phototherapy compared with standard phototherapy.
Conclusion: The study will provide evidence on the comparative effectiveness of two low-cost reflector materials in enhancing phototherapy outcomes, potentially offering a practical and efficient strategy for neonatal hyperbilirubinemia management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group using a white sheet as reflective material in conjunction with phototherapy | Experimental | Other: reflective materialThe three sides of the incubator will be covered with a cardboard panel, cut to fit the incubator dimensions, lined with white linen cloth on the inner surface (length 88 cm, width 47 cm, height 34 cm). |
| Group Using Aluminum Foil as Reflective Material in Combination with Phototherapy | Experimental | Other: reflective materialThe incubators will be enclosed by a panel covered with aluminum foil on three sides (long side 88 cm, short side 47 cm, height 34 cm). |
| Group Receiving Standard Single Phototherapy | No intervention | –Infants will receive treatment in accordance with standard phototherapy practice. |
Who may qualify
- Ages
- 36 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Neonates with total serum bilirubin levels between 15-20 mg/dL
- Gestational age between 35-42 weeks
- Birth weight between 2500-4000 g
- APGAR score of 7-10 at the 1st and 5th minutes after birth
- Fed with breast milk and/or formula
Key exclusion criteria (8 listed)
- Neonates with Rh incompatibility
- Neonates with ABO incompatibility
- Neonates with any congenital anomaly
- Neonates with asphyxia
- Neonates receiving intensive (double) phototherapy
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 |
|---|---|---|
| reflective materialWhen receiving phototherapy treatment in groups, reflective materials (aluminum foil-coated sheet or white sheet-covered sheet) were placed in the incubators. | Other | Group Using Aluminum Foil as Reflective Material in Combination with Phototherapy, Group using a white sheet as reflective material in conjunction with phototherapy |
Primary outcome
Change in Total Serum Bilirubin Level
Time frame: At baseline (prior to phototherapy), 4 hours after initiation, and at the final assessment before discontinuation of phototherapy (up to 24 hours)
The difference in total serum bilirubin concentration measured at baseline (before phototherapy), at the 4th hour, and at the last measurement during phototherapy, expressed in mg/dL.
Duration of Phototherapy
Time frame: Measured once at completion of phototherapy (up to 24 hours after initiation)
Total duration of phototherapy received by each infant, recorded in 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 14 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reflective material in people with Premature and Phototherapy, run by Kubra Nur Kabakcı Sarıdağ 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 7 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 14 Sep 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 Total Serum Bilirubin Level (time frame: At baseline (prior to phototherapy), 4 hours after initiation, and at the final assessment before discontinuation of phototherapy (up to 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 14 Sep 2026.