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| ID | Type | Description | Link |
|---|---|---|---|
| 2023/122 | Other Identifier | Gülhane Clinical Research Ethics Committee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control Group - Standard Phototherapy | Active Comparator | Neonates received standard phototherapy without a white reflective drape or additional reflective materials. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phototherapy with White Reflective Drape | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum bilirubin level at 24 hours | Serum bilirubin level measured at baseline and at 24 hours after initiation of phototherapy. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum bilirubin level at 4 hours | Serum bilirubin level measured at baseline and at 4 hours. | 4 hours |
| Bilirubin change rate between 0-4 hours | Percentage change in bilirubin from baseline to 4 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berna EREN FİDANCI, Assoc. Prof. Dr. | Gülhane Faculty of Nursing, Child Health and Disease Nursing Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gazi University Hospital, Neonatal Intensive Care Unit | Ankara | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D007565 | Jaundice |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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.
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This was an open-label study; no masking was applied.
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| Standard Phototherapy | Device | Phototherapy device (24 blue LED, 1 red LED, Ertunç Özcan) at 35 cm distance; no reflective drape or additional reflective material used. |
|
| 0-4 hours |
| Bilirubin change rate between 4-24 hours | Percentage change in bilirubin from 4 to 24 hours. | 4-24 hours |
| Bilirubin change rate between 0-24 hours | Percentage change in bilirubin from baseline to 24 hours. | 0-24 hours |
| Duration of phototherapy | Total duration of phototherapy administered until bilirubin decreased below treatment threshold. | Up to 72 hours |
| Hospital length of stay due to hyperbilirubinemia | Total hospitalization duration (hours) from admission to discharge. | Up to 7 days |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |