| CTRI Number |
CTRI/2023/11/060204 [Registered on: 23/11/2023] Trial Registered Prospectively |
| Last Modified On: |
22/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Standard vs nlite360 phototherapy: which is better |
|
Scientific Title of Study
|
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
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tejo pratap Oleti |
| Designation |
HOD |
| Affiliation |
Fernandez Hospital |
| Address |
Stork Home,
NICU, 3rd floor,
Division of Neonatology
8-2-698, Road No. 12, Bhola Nagar, Banjara Hills, Hyderabad, Telangana
Hyderabad
TELANGANA
500034
India |
| Phone |
9989372490 |
| Fax |
|
| Email |
tejopratap@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tejo pratap Oleti |
| Designation |
HOD |
| Affiliation |
Fernandez Hospital |
| Address |
Stork Home,
NICU, 3rd floor,
Diviion of Neonatology
8-2-698, Road No. 12, Bhola Nagar, Banjara Hills, Hyderabad, Telangana
TELANGANA
500034
India |
| Phone |
9989372490 |
| Fax |
|
| Email |
tejopratap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tejo pratap Oleti |
| Designation |
HOD |
| Affiliation |
Fernandez Hospital |
| Address |
Stork Home,
NICU, 3rd Floor,
Division of Neonatology
8-2-698, Road No. 12, Bhola Nagar, Banjara Hills, Hyderabad, Telangana
TELANGANA
500034
India |
| Phone |
9989372490 |
| Fax |
|
| Email |
tejopratap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Haemac Healthcare PVT LTD
1ST FLOOR, PLOT NO 59 AND 60, Sardar Patel Nagar, Sardar Patel Nagar Road, JNTU, KPHB, Hyderabad, Medchal Malkajgiri, Telangana, 500085 |
|
|
Primary Sponsor
|
| Name |
Fernandez Foundation |
| Address |
4-4-1-1230, Boggulkunta, Hyderabad, Telangana 500001 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishnu Vardhan |
Fernandez Hospital |
NICU, 3rd floor, Department of Neonatology, Stork Home,
Fernandez Hospital,
Road no 12, Banzaara Hills,
Hyderabad
Hyderabad
TELANGANA |
9989372490
kota.vishnuvardhan@gmail.com |
| Dr Alimelu |
Niloufer Hospital |
NICU,3rd floor, Department of Neonatology, Intensive care Block, Niloufer Hospital
Redhills
Lakdikapul
Hyderabad
TELANGANA |
9391319672
asvnrao@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| BHR COMMMITTEE |
Approved |
| INSTITUTEREVIEWBOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K768||Other specified diseases of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Phototherapy |
All late preterm and term neonates who have neonatal jaundice due and require phototherapy as per AAP guidelines will be given phototherapy with LED device. They will be monitored for the response with serial TSB. We continue phototherapy till the childs TSB comes down below the cutoff ranges at least 2 times. We will assess the primary outcome after 24 hrs and children will be followed for next 7 days for the requirement of photherapy. |
| Intervention |
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 nlite360 device. They will be monitored for the response with serial TSB. We continue phototherapy till the childs TSB comes down below the cutoff ranges at least 2 times. We will assess the primary outcome after 24 hrs and children will be followed for next 7 days for the requirement of photherapy. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
Neonates born after 35weeks gestation
AND Birth weight more than 1.8 kg
AND have Unconjugated hyperbilirubinemia, requiring phototherapy (as per AAP guidelines 2022) |
|
| ExclusionCriteria |
| Details |
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) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the rate of fall of bilirubin |
the rate of fall of bilirubin |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of phototherapy |
Duration from starting to ending of phototherapy |
Incidence of hypothermia (axillary temperature <36.5oC) and hyperthermia (axillary temperature
>38.0Oc) |
As measured by digital thermometer during phototherapy |
| Percentage of weight loss during phototherapy |
Calculated based on weight difference during starting and stopping of phototherapy in relation to birth weight |
| Exclusive breastfeeding rates at discharge |
At dischargee |
| Incidence of rebound hyperbilirubinemia |
Phototherapy requiring initiation of phototherapy after 12-24 hours of
discontinuing the phototherapy as per AAP guidelines. |
|
|
Target Sample Size
|
Total Sample Size="212"
Sample Size from India="212"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/11/2023 |
| 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 Yet Recruiting |
| 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
|
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. |