| CTRI Number |
CTRI/2026/02/104949 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Validation of New nLite 360 Phototherapy Device to reduce Jaundice in Neonates |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prashanth Thankachan |
| Designation |
Professor |
| Affiliation |
St. Johns Research Institute |
| Address |
Room Number 4, Division of Nutrition,
1st Floor St. Johns Research Institute Kormangala Bangalore.
Bangalore
KARNATAKA
560034
India |
| Phone |
08049467054 |
| Fax |
|
| Email |
prashanth.t@sjri.res.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanth Thankachan |
| Designation |
Professor |
| Affiliation |
St. Johns Research Institute |
| Address |
Room Number 4, Division of Nutrition,
1st Floor St. Johns Research Institute Kormangala Bangalore.
Bangalore
KARNATAKA
560034
India |
| Phone |
08049467054 |
| Fax |
|
| Email |
prashanth.t@sjri.res.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashanth Thankachan |
| Designation |
Professor |
| Affiliation |
St. Johns Research Institute |
| Address |
Room Number 4, Division of Nutrition,
1st Floor St. Johns Research Institute Kormangala Bangalore.
Bangalore
KARNATAKA
560034
India |
| Phone |
08049467054 |
| Fax |
|
| Email |
prashanth.t@sjri.res.in |
|
|
Source of Monetary or Material Support
|
| Inidan Council of Medical Research - Center for Advance Research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, Post office Box Number 4911, Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prashanth Thankachan |
St. Johns Research Institute |
Room number 4, 1st Floor, 100 Feet Road, John Nagar, Koramangala, Bengaluru, Karnataka 560034
Bangalore
KARNATAKA |
08049467054
prashanth.t@sjri.res.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St. Johns Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P599||Neonatal jaundice, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nLite 360 phototherapy device |
To reduce Bilirubin in neonates using new Nlite 360 phtotherapy device till reduction of bilrubin levels |
| Comparator Agent |
Standard Phototherapy device |
To reduce Bilirubin in neonates using standard phtotherapy device |
|
|
Inclusion Criteria
|
| Age From |
0.00 Month(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
a. Gestational age greater than equal to thirty five weeks
b. Unconjugated hyperbilirubinemia requiring phototherapy as outlined by American Academy of Peadiatrics guidelines 2022 |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
Base line at the time of Recruitment and Post phototherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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. |
Base line at the time of Recritment and Post phototherapy |
|
|
Target Sample Size
|
Total Sample Size="268"
Sample Size from India="268"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/03/2027 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective single center open label randomized controlled trial which will be conducted to evaluate the safety efficacy and usability of the nLite360 phototherapy device compared with conventional Light Emitting Diode phototherapy in neonates greater than equal to35 weeks gestation with non hemolytic unconjugated hyperbilirubinemia. A total of 268 eligible neonates will be randomized in a 1:1 ratio using block randomization with allocation concealment The intervention group will receive phototherapy using nLite360 single double high intensity or portable modes while the control group will receive centers standard phototherapy The primary outcome is the rate of total serum bilirubin decline mg/dL/hour and over 24 hours Secondary outcomes include temperature instability assessment of side effects hospital stay maternal and staff usability assessment using a validated Likert scale exchange transfusion and phototherapy duration requirement. Statistical analysis will follow an intention to treat approach The trial aims to generate clinical evidence to support regulatory validation and clinical adoption of the device. |