| CTRI Number |
CTRI/2025/07/091726 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Improving Jaundice Care for Newborns in India: Using a Quick Skin Test Instead of Blood Draws
|
|
Scientific Title of Study
|
The Usefulness of Transcutaneous Bilirubinometry in Newborns: Implications on Clinical Practice in Indian Population. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC/2024/DNB/PEAD/45 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
POORVI BISHT |
| Designation |
Principal Investigator |
| Affiliation |
H. N. Reliance Foundation Hospital and Research Centre |
| Address |
Department of Pediatrics,Heritage Building, 1st Floor, Raja Ram Mohan Roy Road,Prathna Samaj, Girgaon
Mumbai
MAHARASHTRA
400004
India |
| Phone |
8511355646 |
| Fax |
|
| Email |
Poorvi.Bisht@rfhospital.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul J Verma |
| Designation |
Director of Pediatric Sciences |
| Affiliation |
Sir H. N. Reliance Foundation Hospital and Research Centre |
| Address |
Department of Pediatrics,Heritage Building, 1st Floor, Raja Ram Mohan Roy Road,Prathna Samaj, Girgaon
Mumbai
MAHARASHTRA
400004
India |
| Phone |
9930909956 |
| Fax |
|
| Email |
Rahul.J.Verma@rfhospital.org |
|
Details of Contact Person
Public Query
|
| Name |
POORVI BISHT |
| Designation |
Principal Investigator |
| Affiliation |
Sir H. N. Reliance Foundation Hospital and Research Centre |
| Address |
Department of Pediatrics,Heritage Building, 1st Floor, Raja Ram Mohan Roy Road,Prathna Samaj, Girgaon
Mumbai
MAHARASHTRA
400004
India |
| Phone |
8511355646 |
| Fax |
|
| Email |
Poorvi.Bisht@rfhospital.org |
|
|
Source of Monetary or Material Support
|
| Sir H. N. Reliance Foundation Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Poorvi Bisht |
| Address |
Sir H. N. Reliance Foundation Hospital and Research Centre, Department of Pediatrics,Heritage Building, 1st Floor, Raja Ram Mohan Roy Road,Prathna Samaj, Girgaon, Mumbai, Maharashtra 400004 |
| Type of Sponsor |
Other [Self] |
|
|
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 Poorvi Bisht |
Sir H. N. Reliance Foundation Hospital and Research Centre |
Department of Pediatrics,Heritage Building, 1st Floor, Raja Ram Mohan Roy Road,Prathna Samaj, Girgaon, Mumbai, Maharashtra 400004
Mumbai
MAHARASHTRA |
8511355646
Poorvi.Bisht@rfhospital.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Neonates till day 10 of life who will develope physiological jaundice. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
10.00 Day(s) |
| Gender |
Both |
| Details |
All newborns (less than 10 days of life) irrespective of the age of gestation, parity, mode of delivery, mode of feeding who have jaundice that seem significant to the naked eye. (Krammer zone 3 and beyond)
Newborns with jaundice who have not received any treatment in the form of exchange blood transfusion.
Newborns receiving phototherapy with a photo opaque heat reflective patch over the area of the forehead, and sternum where TCB measurement will be taken from.
|
|
| ExclusionCriteria |
| Details |
Neonates whose age is more than 10 days of life.
Neonates who needed exchange transfusion.
When a serum value is not available.
Severe multiple anomalies.
Patients with known liver disease, conjugated hyperbilirubinemia, or metabolic disorders that affect bilirubin metabolism.
Those who had culture-proven sepsis.
Unwillingness to participate or refusal of consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The findings of this study will have implications for clinical practice in managing neonatal jaundice. If TcB measurements are found to be accurate and reliable, they could replace serum bilirubin measurements in some settings, reducing the need for invasive procedures and improving the care of newborns with jaundice
|
at baseline, 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="97"
Sample Size from India="97"
Final Enrollment numbers achieved (Total)= "97"
Final Enrollment numbers achieved (India)="97" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/08/2025 |
| Date of Study Completion (India) |
15/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Aim:To determine the correlation between transcutaneous bilirubin (TcB) levels and total serum bilirubin levels in newborns, born in a tertiary care hospital.
Objective:To determine the accuracy of TcB measurements with respect to corresponding serum bilirubin levels. To evaluate the effectiveness of TcB measurements in predicting the need for phototherapy.
|