EVALUATION OF THERMAL, HEMATO-HISTOLOGICAL AND DERMATOLOGICAL BIOCOMPATIBILITY OF A LED DEVICE FOR NEONATAL PHOTOTHERAPY

Description

Phototherapy is the treatment of choice for neonatal hyperbilirubinemia. Portable devices for phototherapy, such as fiber optic blankets, are efficient, produce less heat, have low energy consumption, and allow greater proximity between mothers and newborns. The objective of this study was to test the biocompatibility of a new low-cost device, consisting of a blanket with Light Emitting Diode (LED) lamps. Fourteen rabbits were randomized into two study groups: the treated group (TG: n = 7) received phototherapy in two 12-hour sessions, on two consecutive days, and the control group (CG: n = 7) remained in the same conditions, but with the device turned off. The LED device remained in contact with the skin, emitting mean irradiance of 19.3 (13.0-22.0) µw/cm²/nm. Skin and rectal temperatures were monitored in all animals during the experiment. Clinical alterations of the skin were evaluated, and samples of cutaneous and gonadal tissue for histological analysis were collected on the seventh day of the experiment. Blood samples for hematological and biochemical analysis were collected at three times: before starting treatment, after day 1 and after day 2. Temperature data (5 time points) Hematological data (3 time points) Biochemical data (3 time points) Weight (3 time points) Skin assessment (7 time points) Skin images (4 time points)

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The protocol will be sent for publication and will be published in the doctoral thesis. 1- Randomization : CG device off (7) TG device on (7); 2 - Animal acclimatization period; 3 - Ventrolateral trichotomy; 4 - Serum collection, sedation, hair removal; 5 - 1st skin analysis/photograph and weighing; 6 - 1st day of Treatment Group(TG) /Sham Group(SG) (12 h); 7 - 2nd skin analysis/photograph; (10-hour interval) 8 - Serum collection, sedation; 9 - 3rd skin analysis/photograph and weighing; 10 - 2nd day of Treatment Group (TG) /Sham Group (SG) (12 h); 11- 4th skin analysis/photograph and weighing; 12 - 5th skin analysis 13 - 6th skin analysis; 14 - Castration and gonadal tissue collection; 15 - 7th skin analysis; 16 - Euthanasia and epithelial tissue collection.

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