Standard vs nlite360 phototherapy: which is better
Phase 4
- Conditions
- Health Condition 1: K768- Other specified diseases of liver
- Registration Number
- CTRI/2023/11/060204
- Lead Sponsor
- Fernandez Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Neonates born after 35weeks gestation
AND Birth weight more than 1.8 kg
AND have Unconjugated hyperbilirubinemia, requiring phototherapy (as per AAP guidelines 2022)
Exclusion Criteria
Neonates requiring exchange transfusion or
o Hemodynamically unstable – need for respiratory support, inotropes, etc.
o Congenital anomalies (major)
o Symptoms of acute bilirubin encephalopathy
o Rh iso-immunization or ABO incompatibility ( DCT +ve / ICT +ve)
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the rate of fall of bilirubinTimepoint: the rate of fall of bilirubin
- Secondary Outcome Measures
Name Time Method Duration of phototherapyTimepoint: Duration from starting to ending of phototherapy;Exclusive breastfeeding rates at dischargeTimepoint: At dischargee;Incidence of hypothermia (axillary temperature <36.5oC) and hyperthermia (axillary temperature <br/ ><br> >38.0Oc)Timepoint: As measured by digital thermometer during phototherapy;Incidence of rebound hyperbilirubinemiaTimepoint: Phototherapy requiring initiation of phototherapy after 12-24 hours of <br/ ><br>discontinuing the phototherapy as per AAP guidelines.;Percentage of weight loss during phototherapyTimepoint: Calculated based on weight difference during starting and stopping of phototherapy in relation to birth weight