Fototerapi adalah intervensi terapeutik non-invasif yang digunakan untuk mengatasi ikterus neonatorum. Prosedur ini memanfaatkan berbagai sumber pencahayaan, seperti lampu fluoresen, halogen, fiberoptik, dan Light Emitting Diode (LED), untuk memfasilitasi pemecahan dan mobilisasi bilirubin dalam tubuh neonatus. Beberapa studi terdahulu telah menunjukkan bahwa penggunaan lampu LED efektif dalam menurunkan kadar bilirubin, memperpendek durasi perawatan, mengurangi biaya rumah sakit, dan meningkatkan kualitas pelayanan medis. Penelitian ini bertujuan untuk mengembangkan selimut fototerapi sederhana berbasis LED, melaksanakan uji klinis pendahuluan, dan kemudian melakukan Uji Acak Terkontrol (RCT) untuk menilai dan membandingkan efikasi selimut fototerapi LED BLUI Blanket dengan fototerapi fluoresen. Pengembangan selimut fototerapi LED dilaksanakan dari Februari 2020 hingga Februari 2022 dan diuji di laboratorium Uji Produk di BPFK Jakarta. Prototipe Selimut Fototerapi BLUI Blanket berhasil memperoleh sertifikat lulus uji dari BPFK Jakarta pada Februari 2022. Penelitian pendahuluan dilaksanakan dari Desember 2022 hingga Februari 2023 yang melibatkan 14 bayi dengan ikterus neonatorum. Hasilnya, penggunaan prototipe selimut LED BLUI Blanket secara signifikan menurunkan kadar bilirubin serum rata-rata sebesar 3,11 mg/dL setelah 24 jam fototerapi. RCT dilaksanakan dari April 2023 hingga April 2024, melibatkan 100 bayi dengan ikterus neonatorum yang dibagi ke dalam dua kelompok: kelompok selimut fototerapi LED BLUI Blanket dan kelompok fototerapi fluoresen. Hasil penelitian menunjukkan bahwa selimut LED BLUI Blanket secara signifikan menurunkan kadar bilirubin serum dengan rata-rata sebesar 1,40 mg/dL setelah 24 jam fototerapi. Meskipun begitu, fototerapi menggunakan LED BLUI Blanket menunjukkan efikasi yang lebih rendah dibandingkan dengan fototerapi fluoresen dalam menurunkan kadar bilirubin (RR=0,576; CI 95% [0,33-1,02]; p=0,049). Pengembangan selimut fototerapi BLUI Blanket berbasis LED menawarkan alternatif yang menjanjikan untuk perangkat fototerapi dalam penurunan kadar bilirubin neonatus yang tinggi. Namun demikian, diperlukan modifikasi perangkat dan peningkatan protokol untuk memperbaiki kinerja dan mengoptimalkan alat agar sesuai dengan potensi yang ditunjukkan dalam uji laboratorium.
Phototherapy is a non-invasive therapeutic intervention used to treat neonatal jaundice. This procedure utilizes various light sources, including fluorescent lamps, halogen, fiber optic, and Light Emitting Diode (LED), to facilitate the breakdown and mobilization of bilirubin in the newborn's body. Previous studies have shown that the use of LED lights is effective in reducing bilirubin levels, shortening treatment duration, lowering hospital costs, and enhancing the quality of medical services. This study aims to develop a simple LED-based phototherapy blanket, conduct preliminary clinical trials, and subsequently perform a Randomized Controlled Trial (RCT) to evaluate and compare the efficacy of the LED BLUI Blanket phototherapy with fluorescent phototherapy. The development of the LED phototherapy blanket was carried out from February 2020 to February 2022 and tested at the Product Testing Laboratory at BPFK Jakarta. The prototype LED BLUI Blanket Phototherapy obtained a certification of passing the test from BPFK Jakarta in February 2022. Preliminary research was conducted from December 2022 to February 2023, involving 14 newborns with neonatal jaundice. The results showed that the use of the LED BLUI Blanket prototype significantly reduced serum bilirubin levels by an average of 3.11 mg/dL after 24 hours of phototherapy. The RCT was conducted from April 2023 to April 2024, involving 100 newborns with neonatal jaundice divided into two groups: the LED BLUI Blanket phototherapy group and the fluorescent phototherapy group. The results of the study indicated that the LED BLUI Blanket significantly reduced serum bilirubin levels by an average of 1.40 mg/dL after 24 hours of phototherapy. However, phototherapy using the LED BLUI Blanket showed lower efficacy compared to fluorescent phototherapy in reducing bilirubin levels (RR=0.576; CI 95% [0.33-1.02]; p=0.049). The development of the LED BLUI Blanket phototherapy offers a promising alternative for phototherapy devices in reducing elevated bilirubin levels in newborns. Nevertheless, device modifications and protocol enhancements are needed to improve performance and optimize the tool to match its shown potential in laboratory tests
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