Neonatal HyperbilirubinemiaNCT07156721
White Reflective Drape in Phototherapy for Neonatal Hyperbilirubinemia
A study testing Phototherapy with White Reflective Drape and Standard Phototherapy in people with Neonatal Hyperbilirubinemia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial investigated the effect of using a white reflective drape during phototherapy on serum bilirubin levels and hospital stay in neonates diagnosed with hyperbilirubinemia. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Neonatal Hyperbilirubinemia
- What is being tested?
- Phototherapy with White Reflective Drape and Standard Phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 18 Aug 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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age ≥ 34 weeks
- Diagnosed with hyperbilirubinemia
- Physician decision to initiate phototherapy Written informed consent obtained from parents
Who cannot join
- Critical illness (e.g., ECMO, nitric oxide therapy)
- Congenital anomalies
- Blood group incompatibility or positive Coombs test
- Bilirubin level at exchange transfusion threshold
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Hospital, Neonatal Intensive Care Unit
Ankara
About this study
Official title: The Effect of Using a White Reflective Drape During Phototherapy on Bilirubin Levels and Hospital Stay in Neonates
This randomized controlled trial investigated the effect of using a white reflective drape during phototherapy on serum bilirubin levels and hospital stay in neonates diagnosed with hyperbilirubinemia. A total of 102 newborns (≥34 weeks gestational age) were randomized into two groups: an intervention group (phototherapy with a white reflective drape) and a control group (standard phototherapy). Serum bilirubin levels were measured at baseline, 4 hours, and 24 hours. The primary outcome was the reduction in serum bilirubin at 24 hours, and secondary outcomes included bilirubin reduction rates at different time intervals, phototherapy duration, and hospital stay.
Read the detailed description
Neonatal hyperbilirubinemia is one of the most common conditions in the neonatal period and may lead to severe complications if untreated. Phototherapy is the standard treatment; however, its effectiveness can be improved by using reflective materials to enhance light exposure.
In this single-center randomized controlled trial, conducted between October 2023 and August 2024 at the Neonatal Intensive Care Unit of a University Hospital in Ankara, Turkey, a total of 102 neonates with hyperbilirubinemia were enrolled. Inclusion criteria were: gestational age ≥34 weeks, diagnosis of hyperbilirubinemia, physician decision to initiate phototherapy, and written parental consent. Exclusion criteria included critical health conditions (e.g., Extracorporeal membrane oxygenation or nitric oxide therapy), congenital anomalies, blood group incompatibility or positive Coombs test, and bilirubin at exchange transfusion threshold.
Participants were randomized into two groups (n=51 per group). In the intervention group, a white reflective drape made of double-layer alpaca fabric (125 × 105 cm) was placed around the phototherapy device (three sides plus overhead) and a white sheet was placed under the neonate. The control group received standard phototherapy without a reflective drape. Phototherapy was administered using an Ertunç Özcan device with 24 blue LED lamps and one red focusing light. Serum bilirubin levels were measured from capillary blood samples at baseline, 4 hours, and 24 hours, maintaining a device-to-infant distance of 35 cm.
The primary outcome was the change in serum bilirubin at 24 hours. Secondary outcomes included bilirubin reduction rates (0-4h, 4-24h, 0-24h), phototherapy duration, and hospital length of stay. Statistical analysis was performed using SPSS v23, applying t-test, Mann-Whitney U, Friedman, and Dunn's tests, with significance set at p<0.05.
- Conditions
- Neonatal Hyperbilirubinemia
- Being tested
- Phototherapy with White Reflective Drape, Standard Phototherapy
- Keywords
- Phototherapy, White Reflective Drape, Bilirubin, Jaundice, Newborn, Neonatal Intensive Care, nursing
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phototherapy with White Reflective DrapeDevice
Phototherapy device (24 blue LED, 1 red LED, Ertunç Özcan) at 35 cm distance; a double-layer white reflective drape (125 × 105 cm) was placed around three sides and overhead, with a white sheet under the infant.
Standard PhototherapyDevice
Phototherapy device (24 blue LED, 1 red LED, Ertunç Özcan) at 35 cm distance; no reflective drape or additional reflective material used.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - White Reflective Drape | Experimental | Neonates received phototherapy with a white reflective drape placed around three sides and overhead of the device, and a white sheet placed under the infant to increase light reflection. Receives: Device: Phototherapy with White Reflective Drape |
| Control Group - Standard Phototherapy | Active comparator | Neonates received standard phototherapy without a white reflective drape or additional reflective materials. Receives: Device: Standard Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum bilirubin level at 24 hours
Serum bilirubin level measured at baseline and at 24 hours after initiation of phototherapy.
Measured: 24 hours
Secondary outcomes (6)
Change in serum bilirubin level at 4 hours
Serum bilirubin level measured at baseline and at 4 hours.
Measured: 4 hours
Bilirubin change rate between 0-4 hours
Percentage change in bilirubin from baseline to 4 hours.
Measured: 0-4 hours
Bilirubin change rate between 4-24 hours
Percentage change in bilirubin from 4 to 24 hours.
Measured: 4-24 hours
Bilirubin change rate between 0-24 hours
Percentage change in bilirubin from baseline to 24 hours.
Measured: 0-24 hours
Duration of phototherapy
Total duration of phototherapy administered until bilirubin decreased below treatment threshold.
Measured: Up to 72 hours
Hospital length of stay due to hyperbilirubinemia
Total hospitalization duration (hours) from admission to discharge.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Oct 2023
- Primary completion18 Aug 2024
- Study completion18 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HyperbilirubinemiaStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a randomized controlled trial with two parallel groups. Participants were randomly assigned to either the intervention group (phototherapy with a white reflective drape) or the control group (standard phototherapy). Groups were treated simultaneously and outcomes compared at baseline, 4 hours, and 24 hours.
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sıla İpek DURMUŞ, Saglik Bilimleri Universitesi
- Investigators
- Berna EREN FİDANCI, Assoc. Prof. Dr., Principal investigator, Gülhane Faculty of Nursing, Child Health and Disease Nursing Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156721
- Sponsor's protocol ID
- SaglikBilimleriU-SID-01
- Other IDs
- 2023/122
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 15 Sep 2025
- 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 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using a White Reflective Drape During Phototherapy on Bilirubin Levels and Hospital Stay in Neonates
- ClinicalTrials.gov ID
- NCT07156721
- Acronym / sponsor ID
- SaglikBilimleriU-SID-01
- Conditions
- Neonatal Hyperbilirubinemia
- Keywords
- Phototherapy, White Reflective Drape, Bilirubin, Jaundice, Newborn, Neonatal Intensive Care, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 18 Aug 2024 (actual)
- Study completion
- 18 Aug 2024 (actual)
- First posted
- 5 Sep 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 randomized controlled trial investigated the effect of using a white reflective drape during phototherapy on serum bilirubin levels and hospital stay in neonates diagnosed with hyperbilirubinemia. A total of 102 newborns (≥34 weeks gestational age) were randomized into two groups: an intervention group (phototherapy with a white reflective drape) and a control group (standard phototherapy). Serum bilirubin levels were measured at baseline, 4 hours, and 24 hours. The primary outcome was the reduction in serum bilirubin at 24 hours, and secondary outcomes included bilirubin reduction rates at different time intervals, phototherapy duration, and hospital stay.
Detailed description
Neonatal hyperbilirubinemia is one of the most common conditions in the neonatal period and may lead to severe complications if untreated. Phototherapy is the standard treatment; however, its effectiveness can be improved by using reflective materials to enhance light exposure.
In this single-center randomized controlled trial, conducted between October 2023 and August 2024 at the Neonatal Intensive Care Unit of a University Hospital in Ankara, Turkey, a total of 102 neonates with hyperbilirubinemia were enrolled. Inclusion criteria were: gestational age ≥34 weeks, diagnosis of hyperbilirubinemia, physician decision to initiate phototherapy, and written parental consent. Exclusion criteria included critical health conditions (e.g., Extracorporeal membrane oxygenation or nitric oxide therapy), congenital anomalies, blood group incompatibility or positive Coombs test, and bilirubin at exchange transfusion threshold.
Participants were randomized into two groups (n=51 per group). In the intervention group, a white reflective drape made of double-layer alpaca fabric (125 × 105 cm) was placed around the phototherapy device (three sides plus overhead) and a white sheet was placed under the neonate. The control group received standard phototherapy without a reflective drape. Phototherapy was administered using an Ertunç Özcan device with 24 blue LED lamps and one red focusing light. Serum bilirubin levels were measured from capillary blood samples at baseline, 4 hours, and 24 hours, maintaining a device-to-infant distance of 35 cm.
The primary outcome was the change in serum bilirubin at 24 hours. Secondary outcomes included bilirubin reduction rates (0-4h, 4-24h, 0-24h), phototherapy duration, and hospital length of stay. Statistical analysis was performed using SPSS v23, applying t-test, Mann-Whitney U, Friedman, and Dunn's tests, with significance set at p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a randomized controlled trial with two parallel groups. Participants were randomly assigned to either the intervention group (phototherapy with a white reflective drape) or the control group (standard phototherapy). Groups were treated simultaneously and outcomes compared at baseline, 4 hours, and 24 hours.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - White Reflective Drape | Experimental | Device: Phototherapy with White Reflective DrapeNeonates received phototherapy with a white reflective drape placed around three sides and overhead of the device, and a white sheet placed under the infant to increase light reflection. |
| Control Group - Standard Phototherapy | Active comparator | Device: Standard PhototherapyNeonates received standard phototherapy without a white reflective drape or additional reflective materials. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age ≥ 34 weeks
- Diagnosed with hyperbilirubinemia
- Physician decision to initiate phototherapy Written informed consent obtained from parents
Key exclusion criteria (4 listed)
- Critical illness (e.g., ECMO, nitric oxide therapy)
- Congenital anomalies
- Blood group incompatibility or positive Coombs test
- Bilirubin level at exchange transfusion threshold
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 |
|---|---|---|
| Phototherapy with White Reflective DrapePhototherapy device (24 blue LED, 1 red LED, Ertunç Özcan) at 35 cm distance; a double-layer white reflective drape (125 × 105 cm) was placed around three sides and overhead, with a white sheet under the infant. | Device | Intervention Group - White Reflective Drape |
| Standard PhototherapyPhototherapy device (24 blue LED, 1 red LED, Ertunç Özcan) at 35 cm distance; no reflective drape or additional reflective material used. | Device | Control Group - Standard Phototherapy |
Primary outcome
Change in serum bilirubin level at 24 hours
Time frame: 24 hours
Serum bilirubin level measured at baseline and at 24 hours after initiation of phototherapy.
6 secondary outcomes
Change in serum bilirubin level at 4 hours
Time frame: 4 hours
Bilirubin change rate between 0-4 hours
Time frame: 0-4 hours
Bilirubin change rate between 4-24 hours
Time frame: 4-24 hours
Bilirubin change rate between 0-24 hours
Time frame: 0-24 hours
Duration of phototherapy
Time frame: Up to 72 hours
Hospital length of stay due to hyperbilirubinemia
Time frame: Up to 7 days
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 15 Sep 2025.
- Individual participant dataSharing planned: No
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Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
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Newborn Abdominal Massage to Prevent Hyperbilirubinemia
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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.
Berna EREN FİDANCI, Assoc. Prof. Dr. principal investigator
Gülhane Faculty of Nursing, Child Health and Disease 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 Phototherapy with White Reflective Drape and Standard Phototherapy in people with Neonatal Hyperbilirubinemia, run by Saglik Bilimleri Universitesi 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 3 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: finished, as of the sponsor's last update on 15 Sep 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?
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 serum bilirubin level at 24 hours (time frame: 24 hours). 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 15 Sep 2025.