White Reflective Drape in Phototherapy for Neonatal Hyperbilirubinemia

NCT07156721 | Completed

• 2 other identifiers: SaglikBilimleriU-SID-012023/122
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Hyperbilirubinemia

Keywords

Phototherapy; White Reflective Drape; Bilirubin; Jaundice; Newborn; Neonatal Intensive Care; nursing

Outcome Measures

Primary Outcomes (1)

• Change in serum bilirubin level at 24 hours

  Serum bilirubin level measured at baseline and at 24 hours after initiation of phototherapy.

  24 hours

Secondary Outcomes (6)

• Change in serum bilirubin level at 4 hours

  4 hours

• Bilirubin change rate between 0-4 hours

  0-4 hours

• Bilirubin change rate between 4-24 hours

  4-24 hours

• Bilirubin change rate between 0-24 hours

  0-24 hours

• Duration of phototherapy

  Up to 72 hours

Study Arms (2)

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.

Device: Phototherapy with White Reflective Drape

Control Group - Standard Phototherapy

ACTIVE COMPARATOR

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

Device: Standard Phototherapy

Interventions

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.

Intervention Group - White Reflective Drape

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.

Control Group - Standard Phototherapy

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Gazi University Hospital, Neonatal Intensive Care Unit

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Jaundice

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Berna EREN FİDANCI, Assoc. Prof. Dr.

  Gülhane Faculty of Nursing, Child Health and Disease Nursing Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was an open-label study; no masking was applied.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 5, 2025
• Study Start: October 1, 2023
• Primary Completion: August 18, 2024
• Study Completion: August 18, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)