White Reflective Drape in Phototherapy for Neonatal Hyperbilirubinemia

NCT ID: NCT07156721

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-08-18

Brief 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. 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.

Conditions

Neonatal Hyperbilirubinemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group - White Reflective Drape

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.

Group Type: EXPERIMENTAL

Phototherapy with White Reflective Drape

Intervention Type: 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.

Control Group - Standard Phototherapy

Neonates received standard phototherapy without a white reflective drape or additional reflective materials.

Group Type: ACTIVE_COMPARATOR

Standard Phototherapy

Intervention Type: DEVICE

Phototherapy device (24 blue LED, 1 red LED, Ertunç Özcan) at 35 cm distance; no reflective drape or additional reflective material used.

Interventions

Phototherapy with White Reflective Drape

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.

Intervention Type: DEVICE

Standard Phototherapy

Phototherapy device (24 blue LED, 1 red LED, Ertunç Özcan) at 35 cm distance; no reflective drape or additional reflective material used.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Sıla İpek DURMUŞ

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Berna EREN FİDANCI, Assoc. Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Gülhane Faculty of Nursing, Child Health and Disease Nursing Department

Locations

Gazi University Hospital, Neonatal Intensive Care Unit

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023/122

Identifier Type: OTHER

Identifier Source: secondary_id

SaglikBilimleriU-SID-01

Identifier Type: -

Identifier Source: org_study_id