Study to compare safety and efficacy of conventional standalone phototherapy device with nLite360 Phototherapy Unit for treating indirect hyperbilirubinemia among neonates: A Randomized Controlled Trial

Neonatal Jaundice is the yellowish discoloration of skin, sclera and mucous

membranes due to higher serum bilirubin. Phototherapy is the main treatment

for neonatal jaundice. Conventionally a phototherapy unit consists of a single

source of light emitting diode above the bassinet. Literature reveals that

double phototherapy is beneficial over single phototherapy. NLite 360

phototherapy unit with a three light surfaces, with two being over the bassinet

and one being below the bassinet, facing the back of the patient. The use of

single, double, or triple surface of phototherapy can be decided by the

physician, based on the neonates’ bilirubin level. Additionally, nLite units offers

a detachable light source, can provide phototherapy to the neonate during

breastfeeding. This Trial will be carried out in NICU of Fernandez hospital,

Hyderabad, for 9 months. Primary Objective is to compare the rate of fall of

bilirubin in neonates receiving phototherapy using the new nLite360 device

and the standard devices. In Intervention group neonates will be provided

phototherapy with nLite360- Intelligent device, Control group with LED

devices. Secondary Objectives are To compare Duration of phototherapy,

Incidence of hypo and hyperthermia , weight loss during phototherapy

,Exclusive breastfeeding rates at discharge ,Comfort with breastfeeding

.Perceptions of the mothers using the devices ,to check ‘rebound’

hyperbilirubinemia requiring initiation of phototherapy after 12-24 hours of

discontinuing the phototherapy as per AAP guidelines.