| CTRI Number |
CTRI/2017/12/011014 [Registered on: 28/12/2017] Trial Registered Prospectively |
| Last Modified On: |
20/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Early detection of jaundice in newborn children |
|
Scientific Title of Study
|
Hand-held mobile based device for non-invasive Bilirubin monitoring in 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 Sai Sathish Ramamurthy |
| Designation |
Principal Investigator |
| Affiliation |
Sri Sathya Sai Institute of Higher Learning |
| Address |
Department of Chemistry
Sri Sathya Sai Institute of Higher Learning
Prasanthi Nilayam campus, Puttaparthi, Anantapur District
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
8790314405 |
| Fax |
|
| Email |
rsaisathish@sssihl.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sai Sathish Ramamurthy |
| Designation |
Principal Investigator |
| Affiliation |
Sri Sathya Sai Institute of Higher Learning |
| Address |
Department of Chemistry
Sri Sathya Sai Institute of Higher Learning
Prasanthi Nilayam campus, Puttaparthi, Anantapur District
ANDHRA PRADESH
515134
India |
| Phone |
8790314405 |
| Fax |
|
| Email |
rsaisathish@sssihl.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sai Sathish Ramamurthy |
| Designation |
Principal Investigator |
| Affiliation |
Sri Sathya Sai Institute of Higher Learning |
| Address |
Department of Chemistry
Sri Sathya Sai Institute of Higher Learning
Prasanthi Nilayam campus, Puttaparthi, Anantapur District
ANDHRA PRADESH
515134
India |
| Phone |
8790314405 |
| Fax |
|
| Email |
rsaisathish@sssihl.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Sathya Sai Institute of Higher Learning (Deemed to be University), Prasanthi Nilayam - 515134, Anantapur District, Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Sri Sathya Sai Institute of Higher Learning |
| Address |
Vidyagiri, Prasanthi Nilayam 515134, Anantapur District, Andhra Pradesh |
| Type of Sponsor |
Other [Academic Institution (Deemed to be University)] |
|
|
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 Muddu Gopi Krishna |
Sri Sathya Sai General Hospital |
Room No. 27, Department of Pediatrics, SSSGH
Prasanthi Nilayam, Puttaparthi – 515134
Anantapur
ANDHRA PRADESH |
9676708496
gopikrishna.dr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Sri Sathya Sai Institute of Higher Learning |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P599||Neonatal jaundice, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
21.00 Day(s) |
| Gender |
Both |
| Details |
1. All neonates between 0 to 3 weeks of life presenting to the Sri Sathya Sai General Hospital with clinically visible jaundice will be part of this study. |
|
| ExclusionCriteria |
| Details |
1. Neonates who have received phototherapy, without the skin patch.
2. Where skin condition does not permit, such as Ichthyosis and Hydrops.
3. Neonates who have received exchange transfusion for any reason.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Real-time estimation of bilirubin in neonates using multi-spectral and digital image data obtained from the hand-held device. |
Sampling every 12 hours. In addition to this, the study will incorporate screening for bilirubin in neonates delivered at SSSGH at 72 hours of life as a part of the unit’s standard operating procedure. The hour specific Bhutani nomogram will be used to guide subsequent follow-up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Facilitate the early diagnosis and management
of jaundice in neonates |
3 years |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
15/01/2018 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In the proposed research, we intend to develop and test a non-invasive transcutaneous bilirubinometer for neonates. The proposed device addresses the concerns and gaps in technology in a developing country like India namely: - Low-cost - Simple operational procedure that doesn’t not need trained professionals - Dual-detection technology for better reliability - Multi-sampling method for enhanced accuracy - Automated internal calibration without the requirement of manual calibration - Instant data transfer to the mobile-phone - Zero maintenance charge (excl. electricity for charging) The device will replace the capital intensive imported equipment in healthcare centers and present a novel and unique ‘MAKE IN INDIA’ product. |