White Reflective Drape in Phototherapy for Neonatal Hyperbilirubinemia

Not Applicable

Completed

• Conditions: Neonatal Hyperbilirubinemia

• Registration Number: NCT07156721
• Lead Sponsor: Saglik Bilimleri Universitesi

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., ECMO 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 Timeline

• Study Start: 2023-10-01
• Primary Completion: 2024-08-18
• Study Completion: 2024-08-18
• Status Verified: 2025-08
• Study First Submitted: 2025-08-27
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in serum bilirubin level at 24 hours	24 hours	Serum bilirubin level measured at baseline and at 24 hours after initiation of phototherapy.

Secondary Outcome Measures

Name	Time	Method
Change in serum bilirubin level at 4 hours	4 hours	Serum bilirubin level measured at baseline and at 4 hours.
Bilirubin reduction rate between 0-4 hours	0-4 hours	Percentage reduction in bilirubin from baseline to 4 hours.
Bilirubin reduction rate between 4-24 hours	4-24 hours	Percentage reduction in bilirubin from 4 to 24 hours.
Bilirubin reduction rate between 0-24 hours	0-24 hours	Percentage reduction in bilirubin from baseline to 24 hours.
Duration of phototherapy	Up to 72 hours	Total duration of phototherapy administered until bilirubin decreased below treatment threshold.
Hospital length of stay due to hyperbilirubinemia	Up to 7 days	Total hospitalization duration (hours) from admission to discharge.

Trial Locations

Locations (1)

Gazi University Hospital, Neonatal Intensive Care Unit; Ankara, Turkey (Türkiye)