| CTRI Number |
CTRI/2025/04/084230 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Oral zinc action in reducing jaundice in term newborns receiving phototherapy. |
|
Scientific Title of Study
|
Effect of oral zinc supplementation in term neonates undergoing phototherapy for hyperbilirubinemia in an industrial hospital, a randomised control 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 |
Talluri Mouna |
| Designation |
DNB Trainee |
| Affiliation |
Tata motors hospital |
| Address |
Tata motors hospital, department of paediatrics, kharangajhar, telco colony, jamshedpur-831004.
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
7013803506 |
| Fax |
|
| Email |
mouna.talur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Sharma |
| Designation |
MD Paediatrics, senior consultant |
| Affiliation |
Tata motors hospital |
| Address |
Tata motors hospital, department of Paediatrics, kharanghajar, telco colony, jamshedpur-831004
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
9234611371 |
| Fax |
|
| Email |
sharma.vivek@tatamotors.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivek Sharma |
| Designation |
MD Paediatrics, senior consultant |
| Affiliation |
Tata motors hospital |
| Address |
Tata motors hospital, department of Paediatrics, kharanghajar, telco colony, jamshedpur-831004
Purbi Singhbhum
JHARKHAND
831004
India |
| Phone |
9234611371 |
| Fax |
|
| Email |
sharma.vivek@tatamotors.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatrics, Tata motors hospital, kharangajhar, telco colony, jamshedpur, purbi singhbhum, jharkhand-831004 |
|
|
Primary Sponsor
|
| Name |
Tata Motors Hospital |
| Address |
Kharangajhar, telco colony, jamshedpur, east singhbhum, jharkhand, 831004. |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Talluri Mouna |
Tata Motors Hospital |
NICU, Department of Paediatrics, Tata motors hospital, kharangajhar, telco colony, jamshedpur-831004.
Purbi Singhbhum
JHARKHAND |
7013803506
mouna.talur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, TATA MOTORS HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Zinc and phototherapy. |
Intervention group is given oral Zinc at a dose of 5mg, once daily for 3 days along with phototherapy for hyperbilirubinemia. |
| Comparator Agent |
Phototherapy. |
Control group is given only phototherapy for hyperbilirubinemia. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Term neonates with indirect hyperbilirubinemia under phototherapy range. |
|
| ExclusionCriteria |
| Details |
Preterm neonates.
Direct hyperbilirubinemia.
Systemic illness.
Severe sepsis.
Severe respiratory disease requiring mechanical ventilation
Oral intolerance.
Major gross congenital anomalies (GI malformations, heart and neural tube defects etc).
Term neonates with hyperbilirubinemia in exchange transfusion range.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of fall of total serum bilirubin levels. |
3 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of phototherapy. |
3 DAYS |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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 4 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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
|
In this study, we will compare the effect of oral zinc supplementation in term neonates undergoing phototherapy for hyperbilirubinemia with others receiving only phototherapy in terms of rate of fall in serum bilirubin value and duration of phototherapy at TATA MOTORS HOSPITAL, JAMSHEDPUR.
I want to perform this study because the result will give a novel method of treatment for age old hyperbilirubinemia, reducing NICU stay and newborn and mother separation.
Approval of the instititional ethical committee was taken beforehand.
Written informed consent will be taken prior to the study. Caregivers and patients will be informed about the purpose of study and strict confidentiality will be ensured.
All the patients fitting into the inclusion criteria at NICU, Department of Paediatrics will be enrolled and proper history, examination and relevant investigations will be done.
Data collected wiil be analysed by preliminary data inspection, content analysis and interpretation.
|