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Standard vs nlite360 phototherapy: which is better

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 - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/11/060204
Enrollment
212
Registered
2023-11-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K768- Other specified diseases of liver

Interventions

Intervention1: Phototherapy with nLITE 360 machine: All late preterm and term neonates who have neonatal jaundice due and require phototherapy as per AAP guidelines will be given phototherapy with nli

Sponsors

Fernandez Foundation
Lead Sponsor

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
the rate of fall of bilirubinTimepoint: the rate of fall of bilirubin

Secondary

MeasureTime frame
Duration of phototherapyTimepoint: Duration from starting to ending of phototherapy;Exclusive breastfeeding rates at dischargeTimepoint: At dischargee;Incidence of hypothermia (axillary temperature >38.0Oc)Timepoint: As measured by digital thermometer during phototherapy;Incidence of rebound hyperbilirubinemiaTimepoint: Phototherapy requiring initiation of phototherapy after 12-24 hours of 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

Countries

India

Contacts

Public ContactTejo pratap Oleti

Fernandez Hospital

tejopratap@gmail.com9989372490

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026