| CTRI Number |
CTRI/2024/07/071406 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical studies to check the effectiveness of neutracitical Nanoparticles for its Bilirubin reduction properties |
|
Scientific Title of Study
|
Preclinical studies to investigate citrate- functionalized Tri-Manganese Tetraoxide Nanoparticles for its Bilirubin reduction properties for risk of severe neonatal hyperbilirubinemia. |
| 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 Asim Kumar Mallick |
| Designation |
Professor and In-Charge Neonatal Unit |
| Affiliation |
Nil Ratan Sircar Medical College and Hospital |
| Address |
Department of Paediatrics
138 Acharya Jagdish Chandra Bose Rd, Sealdah Raja Bazar Kolkata West Bengal 700014
Kolkata
WEST BENGAL
700014
India |
| Phone |
9830008057 |
| Fax |
|
| Email |
drasimmallick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asim Kumar Mallick |
| Designation |
Professor and In-Charge Neonatal Unit |
| Affiliation |
Nil Ratan Sircar Medical College and Hospital |
| Address |
Department of Paediatrics
138 Acharya Jagdish Chandra Bose Rd, Sealdah Raja Bazar Kolkata West Bengal 700014
Kolkata
WEST BENGAL
700014
India |
| Phone |
9830008057 |
| Fax |
|
| Email |
drasimmallick@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asim Kumar Mallick |
| Designation |
Professor and In-Charge Neonatal Unit |
| Affiliation |
Nil Ratan Sircar Medical College and Hospital |
| Address |
Department of Paediatrics
138 Acharya Jagdish Chandra Bose Rd, Sealdah Raja Bazar Kolkata West Bengal 700014
Kolkata
WEST BENGAL
700014
India |
| Phone |
9830008057 |
| Fax |
|
| Email |
drasimmallick@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research,V.Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V.Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Asim Kumar Mallick |
Nil Ratan Sircar Medical College and Hospital |
138, Acharya Jagdish Chandra Bose Rd, Sealdah, Raja Bazar, Kolkata, West Bengal 700014. neonatal Unit under Department of Paediatrics,2nd Floor, Centenary Building
Kolkata
WEST BENGAL |
9830008057
drasimmallick@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (E C/NEW/INST/20 23 I 1862 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z673||Type AB blood, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nanoparticle agent vs placebo in Phototherapy group |
2 drops: single dose, (0.25mg /kg of body weight), Oral route of administration, Duration till 48hrs. Only single dose will be used for the treatment. |
| Intervention |
Nanoparticle vs placebo control in Phototherapy group |
Prospective, ethical and compassionate trial for select cohort of neonates at most risk of exchange transfusion and need for “escalated†neonatal care for SNH. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Prospective, ethical and compassionate trial for select cohort of neonates at most risk of exchange transfusion and need for “escalated†neonatal care for SNH to ascertain a long-term childhood reduction in known adverse outcomes. |
|
| ExclusionCriteria |
| Details |
Infants whose parents refused to provide informed consent
Infants with conjugated hyperbilirubinemia
Infants with other threatening congenital anomalies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prospective, ethical and compassionate trial for select cohort of neonates at most risk of exchange transfusion and need for “escalated†neonatal care for SNH to ascertain a long-term childhood reduction in known adverse outcomes. If TSB level after 6hrs (avg time to arrange the blood for blood exchange is 6hrs in our institute) stays beyond exchange level, exchange will be done.
For Phototherapy group. Duration of PT will be noted for both groups. |
0,2,6,12,24,48 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the neurodevelopmental outcomes along with hearing assessment at 8days, 1 month, 3 months, 6months & 1 year. BERA at 3 months, HINE from 3
months onwards, MRI Brain at 6 months besides clinical outcome & nutritional
status & blood test if required. |
8 days, 1 month, 3 month, 6month, 12 months |
|
|
Target Sample Size
|
Total Sample Size="196"
Sample Size from India="196"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
06/08/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 01-09-2024 and end date provided 23-07-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Prospective, ethical and compassionate trial for select cohort of neonates at most risk of exchange transfusion and need for “escalated†neonatal care for SNH to ascertain a long-term childhood reduction in known adverse outcomes. Study: Prospective, ethical and compassionate trial (n=40), Eligibility: TSB @ escalated level, Follow up: 5 years. Study: Adjunctive impact: RCT: placebo, blind (n=80 each arm); Eligibility: TSB at (or <1 mg below Photo Therapy level Follow up: 5 years |