Effectiveness of Aluminum Foil vs White Linen Reflectors in Phototherapy for Neonatal Hyperbilirubinemia

Background: Indirect hyperbilirubinemia (IHB) is a common neonatal condition, affecting over 60% of term and 80% of preterm infants. Phototherapy is the most widely used, safe, and non-invasive treatment; however, scattering of phototherapy light decreases treatment efficacy, prolongs therapy duration, and increases the risk of side effects. Reflective materials have been suggested to enhance phototherapy effectiveness, yet studies comparing different reflector types remain limited.

Aim: This study aims to compare the effects of using reflective materials (white cloth or aluminum foil) during phototherapy on total serum bilirubin levels, phototherapy duration, length of hospital stay, vital signs, side effects, and nurses' satisfaction in neonates with physiological IHB.

Methods: This single-center, single-blind, randomized controlled trial will be conducted at Ankara University Faculty of Medicine, Cebeci Neonatal Intensive Care Unit. A total of 81 neonates with gestational age 35-42 weeks and total serum bilirubin levels of 15-20 mg/dl will be randomly assigned into three groups: (1) phototherapy with white cloth reflectors, (2) phototherapy with aluminum foil reflectors, and (3) standard phototherapy (control). Data will be collected using an Introductory Information Form, Daily Follow-up Chart, Side Effect Observation Form, and Nurse Satisfaction Questionnaire. Statistical analyses will include parametric and non-parametric tests based on distribution assumptions, with significance set at p<0.05.

Expected Results: It is hypothesized that the use of reflective materials will result in faster reduction of total serum bilirubin, shorter phototherapy and hospitalization durations, more stable vital signs, fewer side effects, and higher nurse satisfaction compared with standard phototherapy.

Conclusion: The study will provide evidence on the comparative effectiveness of two low-cost reflector materials in enhancing phototherapy outcomes, potentially offering a practical and efficient strategy for neonatal hyperbilirubinemia management.

Study Overview

• Status: Completed
• Conditions: Phototherapy; Neonatal Hyperbilirubinemia; Premature; Nursing; Neonatal Intensive Care Unit
• Intervention / Treatment: Other: reflective material

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Ankara Bilkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Neonates with total serum bilirubin levels between 15-20 mg/dL
• Gestational age between 35-42 weeks
• Birth weight between 2500-4000 g
• APGAR score of 7-10 at the 1st and 5th minutes after birth
• Fed with breast milk and/or formula
• Written and verbal informed consent obtained from parents
• Neonates who can be reached on the first day of phototherapy treatment

Exclusion Criteria:

• Neonates with Rh incompatibility
• Neonates with ABO incompatibility
• Neonates with any congenital anomaly
• Neonates with asphyxia
• Neonates receiving intensive (double) phototherapy
• Neonates with glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Neonates with serum bilirubin levels close to the exchange transfusion threshold
• Neonates whose parents do not consent to participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group using a white sheet as reflective material in conjunction with phototherapy; The three sides of the incubator will be covered with a cardboard panel, cut to fit the incubator dimensions, lined with white linen cloth on the inner surface (length 88 cm, width 47 cm, height 34 cm).	Other: reflective material; When receiving phototherapy treatment in groups, reflective materials (aluminum foil-coated sheet or white sheet-covered sheet) were placed in the incubators.
Experimental: Group Using Aluminum Foil as Reflective Material in Combination with Phototherapy; The incubators will be enclosed by a panel covered with aluminum foil on three sides (long side 88 cm, short side 47 cm, height 34 cm).	Other: reflective material; When receiving phototherapy treatment in groups, reflective materials (aluminum foil-coated sheet or white sheet-covered sheet) were placed in the incubators.
No Intervention: Group Receiving Standard Single Phototherapy; Infants will receive treatment in accordance with standard phototherapy practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Serum Bilirubin Level	The difference in total serum bilirubin concentration measured at baseline (before phototherapy), at the 4th hour, and at the last measurement during phototherapy, expressed in mg/dL.	At baseline (prior to phototherapy), 4 hours after initiation, and at the final assessment before discontinuation of phototherapy (up to 24 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nurse Satisfaction	Nurses' satisfaction with the use of reflective materials, assessed using a structured questionnaire.	Measured once at completion of phototherapy (up to 24 hours after initiation)
Adverse Events	Incidence of phototherapy-related side effects (e.g., dehydration, hyperthermia, hypothermia, diarrhea, skin rash, bronze baby syndrome).	Measured once at completion of phototherapy (up to 24 hours after initiation)
Duration of Phototherapy	Total duration of phototherapy received by each infant, recorded in hours.	Measured once at completion of phototherapy (up to 24 hours after initiation)

Collaborators and Investigators

• Sponsor: Kubra Nur Kabakcı Sarıdağ

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Actual): June 2, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: September 23, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Infant, Newborn, Diseases; Hyperbilirubinemia; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Premature Birth; Hyperbilirubinemia, Neonatal
• Other Study ID Numbers: KUBRAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No