Neonatal Hyperbilirubinemia
Conditions
Keywords
Phototherapy, White Reflective Drape, Bilirubin, Jaundice, Newborn, Neonatal Intensive Care, nursing
Brief summary
This randomized controlled trial investigated the effect of using a white reflective drape during phototherapy on serum bilirubin levels and hospital stay in neonates diagnosed with hyperbilirubinemia. A total of 102 newborns (≥34 weeks gestational age) were randomized into two groups: an intervention group (phototherapy with a white reflective drape) and a control group (standard phototherapy). Serum bilirubin levels were measured at baseline, 4 hours, and 24 hours. The primary outcome was the reduction in serum bilirubin at 24 hours, and secondary outcomes included bilirubin reduction rates at different time intervals, phototherapy duration, and hospital stay.
Detailed description
Neonatal hyperbilirubinemia is one of the most common conditions in the neonatal period and may lead to severe complications if untreated. Phototherapy is the standard treatment; however, its effectiveness can be improved by using reflective materials to enhance light exposure. In this single-center randomized controlled trial, conducted between October 2023 and August 2024 at the Neonatal Intensive Care Unit of a University Hospital in Ankara, Turkey, a total of 102 neonates with hyperbilirubinemia were enrolled. Inclusion criteria were: gestational age ≥34 weeks, diagnosis of hyperbilirubinemia, physician decision to initiate phototherapy, and written parental consent. Exclusion criteria included critical health conditions (e.g., Extracorporeal membrane oxygenation or nitric oxide therapy), congenital anomalies, blood group incompatibility or positive Coombs test, and bilirubin at exchange transfusion threshold. Participants were randomized into two groups (n=51 per group). In the intervention group, a white reflective drape made of double-layer alpaca fabric (125 × 105 cm) was placed around the phototherapy device (three sides plus overhead) and a white sheet was placed under the neonate. The control group received standard phototherapy without a reflective drape. Phototherapy was administered using an Ertunç Özcan device with 24 blue LED lamps and one red focusing light. Serum bilirubin levels were measured from capillary blood samples at baseline, 4 hours, and 24 hours, maintaining a device-to-infant distance of 35 cm. The primary outcome was the change in serum bilirubin at 24 hours. Secondary outcomes included bilirubin reduction rates (0-4h, 4-24h, 0-24h), phototherapy duration, and hospital length of stay. Statistical analysis was performed using SPSS v23, applying t-test, Mann-Whitney U, Friedman, and Dunn's tests, with significance set at p\<0.05.
Interventions
DEVICEPhototherapy with White Reflective Drape
Phototherapy device (24 blue LED, 1 red LED, Ertunç Özcan) at 35 cm distance; a double-layer white reflective drape (125 × 105 cm) was placed around three sides and overhead, with a white sheet under the infant.
DEVICEStandard Phototherapy
Phototherapy device (24 blue LED, 1 red LED, Ertunç Özcan) at 35 cm distance; no reflective drape or additional reflective material used.
Sponsors
Saglik Bilimleri Universitesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This was an open-label study; no masking was applied.
Intervention model description
This was a randomized controlled trial with two parallel groups. Participants were randomly assigned to either the intervention group (phototherapy with a white reflective drape) or the control group (standard phototherapy). Groups were treated simultaneously and outcomes compared at baseline, 4 hours, and 24 hours.
Eligibility
Sex/Gender
ALL
Age
0 Days to 28 Days
Healthy volunteers
No
Inclusion criteria
* Gestational age ≥ 34 weeks * Diagnosed with hyperbilirubinemia * Physician decision to initiate phototherapy Written informed consent obtained from parents
Exclusion criteria
* Critical illness (e.g., ECMO, nitric oxide therapy) * Congenital anomalies * Blood group incompatibility or positive Coombs test * Bilirubin level at exchange transfusion threshold
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum bilirubin level at 24 hours | 24 hours | Serum bilirubin level measured at baseline and at 24 hours after initiation of phototherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bilirubin change rate between 4-24 hours | 4-24 hours | Percentage change in bilirubin from 4 to 24 hours. |
| Change in serum bilirubin level at 4 hours | 4 hours | Serum bilirubin level measured at baseline and at 4 hours. |
| Bilirubin change rate between 0-24 hours | 0-24 hours | Percentage change in bilirubin from baseline to 24 hours. |
| Duration of phototherapy | Up to 72 hours | Total duration of phototherapy administered until bilirubin decreased below treatment threshold. |
| Hospital length of stay due to hyperbilirubinemia | Up to 7 days | Total hospitalization duration (hours) from admission to discharge. |
| Bilirubin change rate between 0-4 hours | 0-4 hours | Percentage change in bilirubin from baseline to 4 hours. |
Countries
Turkey (Türkiye)
Outcome results
None listed