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Completed

NCT Number: NCT07266246

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.

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Key information

Conditions

Premature Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Neonatal Hyperbilirubinemia Neonatal Intensive Care Unit Nursing Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Phototherapy Pregnancy Complications Premature Birth Urogenital Diseases

Age range

36 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

reflective material

Other

When receiving phototherapy treatment in groups, reflective materials (aluminum foil-coated sheet or white sheet-covered sheet) were placed in the incubators.

Primary outcomes

  1. Change in Total Serum Bilirubin Level

    Time frame: At baseline (prior to phototherapy), 4 hours after initiation, and at the final assessment before discontinuation of phototherapy (up to 24 hours)

    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.

Secondary outcomes

  1. Nurse Satisfaction

    Time frame: Measured once at completion of phototherapy (up to 24 hours after initiation)

    Nurses' satisfaction with the use of reflective materials, assessed using a structured questionnaire.

  2. Adverse Events

    Time frame: Measured once at completion of phototherapy (up to 24 hours after initiation)

    Incidence of phototherapy-related side effects (e.g., dehydration, hyperthermia, hypothermia, diarrhea, skin rash, bronze baby syndrome).

  3. Duration of Phototherapy

    Time frame: Measured once at completion of phototherapy (up to 24 hours after initiation)

    Total duration of phototherapy received by each infant, recorded in hours.

Sponsors and collaborators

Lead sponsor

Kubra Nur Kabakcı Sarıdağ

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2025
Registry last updated
Mar 2, 2026

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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