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Completed

NCT Number: NCT07156721

White Reflective Drape in Phototherapy for Neonatal Hyperbilirubinemia

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.

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Key information

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University Hospital, Neonatal Intensive Care Unit

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age ≥ 34 weeks
  • Diagnosed with hyperbilirubinemia
  • Physician decision to initiate phototherapy Written informed consent obtained from parents

Exclusion criteria

  • Critical illness (e.g., ECMO, nitric oxide therapy)
  • Congenital anomalies
  • Blood group incompatibility or positive Coombs test
  • Bilirubin level at exchange transfusion threshold

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in serum bilirubin level at 4 hours

    Time frame: 4 hours

    Serum bilirubin level measured at baseline and at 4 hours.

  2. Bilirubin change rate between 0-4 hours

    Time frame: 0-4 hours

    Percentage change in bilirubin from baseline to 4 hours.

  3. Bilirubin change rate between 4-24 hours

    Time frame: 4-24 hours

    Percentage change in bilirubin from 4 to 24 hours.

  4. Bilirubin change rate between 0-24 hours

    Time frame: 0-24 hours

    Percentage change in bilirubin from baseline to 24 hours.

  5. Duration of phototherapy

    Time frame: Up to 72 hours

    Total duration of phototherapy administered until bilirubin decreased below treatment threshold.

  6. Hospital length of stay due to hyperbilirubinemia

    Time frame: Up to 7 days

    Total hospitalization duration (hours) from admission to discharge.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

The Effect of Using a White Reflective Drape During Phototherapy on Bilirubin Levels and Hospital Stay in Neonates

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 5, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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