Randomised Controlled Trial on 360° Phototherapy versus Single Surface LED Phototherapy in Neonatal Hyperbilirubinemia

This is a randomised controlled trial. Phototherapy units are set up for both intervention and control groups, which will involve 1 unit of a new 360’ phototherapy device for intervention group and few units of single surface LED phototherapy device for control group. The phototherapy units will be serviced before the study began and it will be maintained in optimal working condition for whole duration of the therapy. The 360’ phototherapy consist of LED blue light (40 LED lights each at the top and bottom of the device). Both of the top and bottom of the device will be made sure to be close throughout the study. The distance between phototherapy unit and babies will be fixed at 30cm for both of the control and intervention group. Pre-study evaluation of light intensity measurement from three different angles (front -- at level of neonate’s skin [on anterior thoracic region – which is the centre of phototherapy light], right and left of the babies) will be done for both 360’ and single surface LED phototherapy using ‘FANEM radiation monitor 2620’. This evaluation will only be done before the start of intervention for all participants involved. This is done to monitor the light intensity emitted by the devices used in the study in all participants involved, measured in uW/cm2/nm. The light intensity for both will be kept at level 5. The intervention will be administered by the NICU staff nurses or health officers in charged. While receiving phototherapy, the light will be continuously on, except during feeding, physical examination and blood taking. Breastfeeding will be continued as per ‘Malaysian Neonatal Jaundice Guideline’. Interruption time will be monitored and restricted. All neonates involved will be ensured to have adequate exposure to the light, in which they will be dressed with nappies only during treatment in both groups, eyes will be covered to prevent retinal damage and strict adherence to study protocol will be ensured. The phototherapy session will be continuous except during feeding, physical examination and blood taking to maintain the optimal therapy. After 24 hours, the intervention will be discontinued. Subjects who still required phototherapy after 24 hours will continue with the treatment irrespective of the type of phototherapy. Intervention will also be discontinued if subjects’ serum bilirubin level are below phototherapy level before reaching 24-hour. All data will then be collected using the proforma checklist. The proforma form will be labelled with code numbers to ensure the confidentiality of all participants are preserved. The proforma form will consists of baseline data, safety profiles monitoring during phototherapy and blood sampling parameters.