| CTRI Number |
CTRI/2022/09/045145 [Registered on: 01/09/2022] Trial Registered Prospectively |
| Last Modified On: |
25/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To study whether non-invasive method (transcutaneous bilirubin) measurement is as accurate as measuring bilirubin level in blood in infants who are born prematurely |
|
Scientific Title of Study
|
correlation between total serum bilirubin and transcutaneous bilirubin levels in preterm neonates |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwani Kumar |
| Designation |
Associate Professor |
| Affiliation |
Sri guru ram das institute of medical sciences and research |
| Address |
Neonatal intensive care unit, department of pediatrics
Amritsar
PUNJAB
143501
India |
| Phone |
|
| Fax |
|
| Email |
docashwani82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwani Kumar |
| Designation |
Associate Professor |
| Affiliation |
Sri guru ram das institute of medical sciences and research |
| Address |
Neonatal intensive care unit, department of pediatrics
Amritsar
PUNJAB
143501
India |
| Phone |
|
| Fax |
|
| Email |
docashwani82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwani Kumar |
| Designation |
Associate Professor |
| Affiliation |
Sri guru ram das institute of medical sciences and research |
| Address |
Neonatal intensive care unit, department of pediatrics
Amritsar
PUNJAB
143501
India |
| Phone |
|
| Fax |
|
| Email |
docashwani82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Guru Ramdas institute of medical sciences and research, Amritsar |
|
|
Primary Sponsor
|
| Name |
none |
| Address |
NA |
| Type of Sponsor |
Other [None] |
|
|
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 |
| Ashwani kumar |
sri guru ram das institute of medical sciences and research |
Neonatal intensive care unit, department of pediatrics
Amritsar
PUNJAB |
7888939017
docashwani82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R238||Other skin changes, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Preterm neonates 35 week with clinical jaundice |
|
| ExclusionCriteria |
| Details |
conjugated hyperbilirubinemia, major malformations,jaundice within 24hrs of life |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| correlation between tsb and tcb |
At baseline, then after 12 hrs |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/09/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/09/2022 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Purpose of the study is to check whether bilirubin measurement using transcutaneous bilirubinometer ( non invasive) is comparable to that measuring blood sample |