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Completed NCT07266246

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

Conditions: Premature, Phototherapy, Neonatal Intensive Care Unit, Neonatal Hyperbilirubinemia, Nursing

Sex: All
Ages: 36 Weeks – 42 Weeks
Healthy volunteers: No
Phase: NA
Enrollment: 81
Sponsor: Kubra Nur Kabakcı Sarıdağ

Location: Ankara Bilkent City Hospital Ankara

Summary

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 and phototherapy duration, 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 and Daily Follow-up Chart. Statistical analyses will include parametric and non-parametric tests based on distribution assumptions, with significance set at p\

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07266246). StuddyBuddy aggregates publicly available trial information.