Neonatal Hyperbilirubinemia, Neonatal Intensive Care Unit, Nursing, Phototherapy, Premature
Conditions
Brief 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\<0.05. Expected Results: It is hypothesized that the use of reflective materials will result in faster reduction of total serum bilirubin and shorter phototherapy 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.
Interventions
OTHERreflective material
When receiving phototherapy treatment in groups, reflective materials (aluminum foil-coated sheet or white sheet-covered sheet) were placed in the incubators.
Sponsors
Kubra Nur Kabakcı Sarıdağ
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
36 Weeks to 42 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Serum Bilirubin Level | 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. |
| Duration of Phototherapy | Measured once at completion of phototherapy (up to 24 hours after initiation) | Total duration of phototherapy received by each infant, recorded in hours. |
Countries
Turkey (Türkiye)
Outcome results
None listed