Validation of New nLite 360 Phototherapy Device to reduce Jaundice in Neonates

A Randomized Controlled Trial Comparing Phototherapy with Single or Double or Portable Modes Versus Conventional Phototherapy in Neonates with Non Hemolytic Unconjugated Hyperbilirubinemia in a Tertiary Care Hospital - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/104949

Enrollment

268

Registered

2026-02-26

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Health Condition 1: P599- Neonatal jaundice, unspecified

Interventions

Intervention1: nLite 360 phototherapy device: To reduce Bilirubin in neonates using new Nlite 360 phtotherapy device till reduction of bilrubin levels Control Intervention1: Standard Phototherapy devi

Eligibility

Inclusion criteria

Inclusion criteria: a. Gestational age greater than equal to thirty five weeks b. Unconjugated hyperbilirubinemia requiring phototherapy as outlined by American Academy of Peadiatrics guidelines 2022

Exclusion criteria

Exclusion criteria: a. Isoimmunization, kernicterus, or conjugated hyperbilirubinemia b. Congenital anomalies or other major co-morbidities c. Ventilator support or hydrops fetalis d. Hemolytic neonates as indicated by reticulocyte count and anemia for age.

Design outcomes

Primary

Measure	Time frame
To compare the rate of bilirubin decline (miligram per decilitre per hour and over twenty four hours) in neonates of gestational age greater than equal to thirty five weeks during phototherapy for non-hemolytic conjugated hyperbilirubinemia, between those treated with novel phototherapy and those receiving conventional phototherapy.Timepoint: Base line at the time of Recruitment and Post phototherapy	—

Measure

Time frame

To compare the rate of bilirubin decline (miligram per decilitre per hour and over twenty four hours) in neonates of gestational age greater than equal to thirty five weeks during phototherapy for non-hemolytic conjugated hyperbilirubinemia, between those treated with novel phototherapy and those receiving conventional phototherapy.Timepoint: Base line at the time of Recruitment and Post phototherapy

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Secondary

Measure	Time frame
a.The mean duration of phototherapy from initiation to clinical resolution between the two groups. b. Comparing the incidence of skin temperature variations between the two groups by continuous monitoring. c. To evaluate any side effects such as loose stools, dehydration, rashes or skin discoloration. d.To evaluate overall maternal and medical personnel perception of the phototherapy device, including Ease of cleaning, Comfort with light exposure, Tolerance of heat and humidity, feeding convenience and Overall baby care experience using a validated 7-point Likert scale at the end of the phototherapy treatment period. e. To evaluate the duration of hospital-stay between the two groups. f.To evaluate the requirement of exchange transfusion between the two groups.Timepoint: Base line at the time of Recritment and Post phototherapy	—

Measure

Time frame

a.The mean duration of phototherapy from initiation to clinical resolution between the two groups. b. Comparing the incidence of skin temperature variations between the two groups by continuous monitoring. c. To evaluate any side effects such as loose stools, dehydration, rashes or skin discoloration. d.To evaluate overall maternal and medical personnel perception of the phototherapy device, including Ease of cleaning, Comfort with light exposure, Tolerance of heat and humidity, feeding convenience and Overall baby care experience using a validated 7-point Likert scale at the end of the phototherapy treatment period. e. To evaluate the duration of hospital-stay between the two groups. f.To evaluate the requirement of exchange transfusion between the two groups.Timepoint: Base line at the time of Recritment and Post phototherapy

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Countries

India

Contacts

Public ContactDr Prashanth Thankachan

St. Johns Research Institute

prashanth.t@sjri.res.in08049467054

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026