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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group using a white sheet as reflective material in conjunction with phototherapy | Experimental | 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). |
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| Group Using Aluminum Foil as Reflective Material in Combination with Phototherapy | Experimental | 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). |
|
| Group Receiving Standard Single Phototherapy | No Intervention | Infants will receive treatment in accordance with standard phototherapy practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital | Ankara | Turkey (Türkiye) |
Individual participant data will not be shared.
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D051556 | Hyperbilirubinemia, Neonatal |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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) |
| D000091642 | Urogenital Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |