| CTRI Number |
CTRI/2024/04/065593 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of probiotics in babies with jaundice |
|
Scientific Title of Study
|
To study the efficacy of Probiotics along with Phototherapy and phototherapy alone in neonatal hyperbilirubinemia: 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 |
Dr Amanpreet Kaur |
| Designation |
Senior Resident |
| Affiliation |
Government Medical College & Rajindra Hospital Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala, Punjab, India.
Patiala
PUNJAB
147001
India |
| Phone |
8283962708 |
| Fax |
|
| Email |
lifestyle.amanpreet@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasbir Singh |
| Designation |
Professor |
| Affiliation |
Government Medical College & Rajindra Hospital Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala, Punjab, India.
Patiala
PUNJAB
147001
India |
| Phone |
9417212020 |
| Fax |
|
| Email |
jsjasbir9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amanpreet Kaur |
| Designation |
Senior Resident |
| Affiliation |
Government Medical College & Rajindra Hospital Patiala |
| Address |
Department of Pharmacology, Government Medical College, Patiala, Punjab, India.
Patiala
PUNJAB
147001
India |
| Phone |
8283962708 |
| Fax |
|
| Email |
lifestyle.amanpreet@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College & Rajindra Hospital Patiala |
|
|
Primary Sponsor
|
| Name |
Government Medical College Rajindra Hospital Patiala |
| Address |
Department of Pharmacology, Government Medical College Patiala, Punjab, India, 147001. |
| Type of Sponsor |
Government medical college |
|
|
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 Amanpreet Kaur |
Government Medical College and Rajindra Hospital, Patiala |
IPD ( In Patient department), Nursery, Department of Paediatrics.
Patiala
PUNJAB |
08283962708
lifestyle.amanpreet@gmail.com |
|
|
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 |
| Patients |
(1) ICD-10 Condition: P599||Neonatal jaundice, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Phototherapy |
Phototherapy in blue-green spectrum with wavelengths of 430-490 nm. |
| Intervention |
Probiotics ( Darolac sachet) + Phototherapy |
Darolac sachet which contains 1.25 billion cells ( lactobacillus acidophilus, lactobacillus rhamnosus, Bifidobacterium longum & saccharomyces boulardii) + Phototherapy |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
21.00 Day(s) |
| Gender |
Both |
| Details |
1. Preterm and term neonates with hyperbilirubinemia (35-40 weeks)
2. Patients with jaundice due to maternal blood type ABO compatibility
3. G6PD deficiency
4. Hypothyroidism
5. Sepsis
|
|
| ExclusionCriteria |
| Details |
1. Patients with gestational age less than 35 weeks.
2. Patients with severe cardiopulmonary illness.
3. Patients with birth weight less than 2,000 grams.
4. Patients having signs of perinatal asphyxia.
5. Patients with congenital anomalies.
6. Patients whose parents refuse to give written informed consent
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| serum bilirubin level lowering efficacy of probiotics along with phototherapy vs phototheray alone in patients of neonatal hyperbilirubinemia |
Day-1, 24 hours, 48 hours and 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in duration of phototherapy in probiotics along with phototherapy and phototherapy alone treatment group |
Day-1, 24 hours, 48 hours and 72 hours |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/04/2024 |
| 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="0"
Months="6"
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
|
This will be a randomized clinical trial
including 150 neonates diagnosed with neonatal hyperbilirubinemia. Patients
will be randomized to two groups - phototherapy with oral probiotics (Darolac)
and phototherapy alone through stratified randomization. Serum Bilirubin Levels
(SBL) at the time of intervention, 24, 48, and 72 hours later, duration of
phototherapy, duration of hospitalization, and any side effect related to
intervention will be assessed and compared in the two groups |