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Evaluation of Thermal, Hematohistological, and Dermatological Biocompatibility of LED Devices for Neonatal
Tayomara Ferreira Nascimento1, Silvia Cristina Mangini Bocchi1, João Cesar Lyra1
1Botucatu Medical School, São Paulo State University (UNESP), São Paulo 18618-687, Brazil.
Insights
A new flexible LED phototherapy blanket for infants is biocompatible and safe. This device allows continuous treatment, avoiding interruptions common with traditional methods, and shows no adverse effects in rabbit models.
Area of Science:
- Neonatal care
- Biomedical engineering
- Phototherapy
Background:
- Infant phototherapy effectiveness depends on total light dose.
- Current methods face interruptions, impacting treatment efficacy.
- A novel device aims for continuous, uninterrupted phototherapy.
Purpose of the Study:
- Develop a flexible, stretchable LED phototherapy device.
- Evaluate the biocompatibility of a novel LED phototherapy blanket.
- Assess the safety and efficacy of continuous phototherapy delivery.
Main Methods:
- New Zealand White rabbits (n=14) were used, divided into treatment (TG) and control (CG) groups.
- TG received 12-hour LED phototherapy for two consecutive days; CG received placebo.
- Biochemical, hematological, dermatological, histological, and temperature parameters were assessed.
Main Results:
- No significant differences in skin appearance or histology between groups.
- TG showed a slight, non-clinically significant reduction in monocyte counts.
- Skin and rectal temperatures remained within physiological limits for both groups.
Conclusions:
- The novel LED phototherapy blanket is biocompatible.
- The device caused no adverse dermatological, hematological, or biochemical effects.
- Continuous phototherapy delivery is feasible without compromising infant safety.
Abstract:
Background/Objective: The effectiveness of blue-light phototherapy (PT) is mainly dependent on the total dose of light (time under PT and amount of skin exposed) received by infants. The primary aim of this study was the development of a novel, flexible, and stretchable device to provide continuous PT treatment, avoiding temporary interruptions that are often observed in practice, such as during breastfeeding, for example. This study evaluated the biocompatibility of a novel, low-cost blanket equipped with light-emitting diode (LED) lamps designed to maintain therapeutic efficacy while facilitating uninterrupted skin-to-skin contact. Methods: Fourteen New Zealand White rabbits, weighing approximately 2.9 kg and aged 4 months, were randomly assigned to an experimental group (TG, n = 7) or a control group (CG, n = 7). The TG received phototherapy directly on the skin (irradiance: 19.3 [13.0-22.0] µW/cm-2/nm-1) during two 12 h sessions over consecutive days, while the CG remained under identical conditions with the device turned off. Biochemical, hematological, dermatological, and histological parameters, as well as rectal and skin temperatures, were assessed. Results: The results showed no differences in clinical appearance or histological analysis of skin tissue between the groups. Blood analysis indicated a reduction in absolute monocyte counts in the TG compared to the CG (p = 0.049), though levels remained within normal ranges. Skin temperature was consistently higher in the TG, except during the initial measurement. Rectal temperatures were similar on the first day but lower in the TG on the second day (mean 40.3 ± 0.21 °C vs. 40.7 ± 0.32 °C; p = 0.039). Conclusions: Temperature levels remained within physiological limits for both groups throughout the study. The device demonstrated biocompatibility and caused no adverse dermatological, hematological, or biochemical effects.
