An interventional study of Phototherapy with White Reflective Drape and Standard Phototherapy in Neonatal Hyperbilirubinemia, sponsored by Saglik Bilimleri Universitesi. Completed at 1 site in Turkey (Türkiye). Open to participants aged 0 Days to 28 Days. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Treatment
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.
96 studies on the registry are indexed under Hyperbilirubinemia, Neonatal; 20 are open to participants now.
This study's enrollment of 102 is close to the median of 100 across 61 interventional studies indexed under Hyperbilirubinemia, Neonatal.
Browse Hyperbilirubinemia, Neonatal studies →Saglik Bilimleri Universitesi is the lead sponsor of 453 studies on the registry; 140 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Phototherapy with White Reflective Drape
Neonates received standard phototherapy without a white reflective drape or additional reflective materials.
Device: Standard Phototherapy
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.
Phototherapy device (24 blue LED, 1 red LED, Ertunç Özcan) at 35 cm distance; no reflective drape or additional reflective material used.
Change in serum bilirubin level at 24 hours
Serum bilirubin level measured at baseline and at 24 hours after initiation of phototherapy.
Time frame: 24 hours
Change in serum bilirubin level at 4 hours
Serum bilirubin level measured at baseline and at 4 hours.
Time frame: 4 hours
Bilirubin change rate between 0-4 hours
Percentage change in bilirubin from baseline to 4 hours.
Time frame: 0-4 hours
Bilirubin change rate between 4-24 hours
Percentage change in bilirubin from 4 to 24 hours.
Time frame: 4-24 hours
Bilirubin change rate between 0-24 hours
Percentage change in bilirubin from baseline to 24 hours.
Time frame: 0-24 hours
Duration of phototherapy
Total duration of phototherapy administered until bilirubin decreased below treatment threshold.
Time frame: Up to 72 hours
Hospital length of stay due to hyperbilirubinemia
Total hospitalization duration (hours) from admission to discharge.
Time frame: Up to 7 days
Plan to share: No
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Hyperbilirubinemia, Neonatal →
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