| CTRI Number |
CTRI/2024/04/065198 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Changes in body functions before and after intravenous caffeine in neonates with birth related brain injury |
|
Scientific Title of Study
|
Physiological responses to intravenous caffeine in neonates with Hypoxic Ischaemic Encephalopathy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol version 1.1 dated 03/01/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reema Garegrat |
| Designation |
Consultant |
| Affiliation |
Perinatal Brain Research Centre and Gupta Neonatal Hospital |
| Address |
Perinatal Brain Research Centre and Gupta Neonatal Hospital,
Floor 1, Department of Neonatology
43-W,
Opposite Pushpa Complex,
Model Town,
Hisar
Hisar
HARYANA
125011
India |
| Phone |
9819588972 |
| Fax |
|
| Email |
pbrc@guptaneonatal.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Reema Garegrat |
| Designation |
Consultant |
| Affiliation |
Perinatal Brain Research Centre and Gupta Neonatal Hospital |
| Address |
Perinatal Brain Research Centre and Gupta Neonatal Hospital,
Floor 1, Department of Neonatology,
43-W,
Opposite Pushpa Complex,
Model Town,
Hisar
Hisar
HARYANA
125011
India |
| Phone |
9819588972 |
| Fax |
|
| Email |
pbrc@guptaneonatal.com |
|
Details of Contact Person
Public Query
|
| Name |
Reema Garegrat |
| Designation |
Consultant |
| Affiliation |
Perinatal Brain Research Centre and Gupta Neonatal Hospital |
| Address |
Perinatal Brain Research Centre and Gupta Neonatal Hospital,
Floor 1, Department of Neonatology
43-W,
Opposite Pushpa Complex,
Model Town,
Hisar
Hisar
HARYANA
125011
India |
| Phone |
9819588972 |
| Fax |
|
| Email |
pbrc@guptaneonatal.com |
|
|
Source of Monetary or Material Support
|
| Perinatal Brain Research Center and Gupta Neonatal Hospital |
|
|
Primary Sponsor
|
| Name |
Reema Garegrat |
| Address |
Perinatal Brain Research Centre & Gupta Neonatal Hospital,
43-W, Opposite Pushpa Complex,
Model Town,
Hisar-125001 |
| Type of Sponsor |
Other [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 Reema Garegrat |
Gupta Neonatal Hospital |
First floor,
Neonatal Intensive care unit, Department of Neonatology,
43-W, Opposite Pushpa Complex,
Model Town,
Hisar-125001
Hisar
HARYANA |
9819588972
reemas532@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aadhar Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Caffeine |
Single dose of caffeine citrate at 20mg/kg between 36 to 50 hours of life given via the intravenous route of administration |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
All male and female newborns with hypoxic ischemic encephalopathy till 30 days of life |
|
| ExclusionCriteria |
| Details |
No sex is excluded.
Age beyond 30 days is excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in cerebral oxygenation pre and post caffeine administration |
Change in cerebral oxygenation pre and post caffeine administration between 36 to 50 hours of life only.
Baseline 2 hours before administering caffeine and second 2 hours after administering caffeine |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in renal and Splanchnic oxygenation index pre and post caffeine administration
Change in Cerebral, mesenteric, celiac artery doppler pre and post caffeine administration
Seizure burden before and after caffeine
Heart Rate Variability index before and after caffeine
NPASS (Pain score) before and after caffeine
|
Before and after caffeine administration between 36 to 50 hours of age |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "8"
Final Enrollment numbers achieved (India)="8" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/04/2024 |
| Date of Study Completion (India) |
14/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included www.guptaneonatal.com).
- For how long will this data be available start date provided 16-04-2025 and end date provided 15-04-2027?
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
|
Administration of intravenous caffeine in babies with moderate to severe encephalopathy will be done along with calculation of cerebral oxygenation before and after giving intravenous caffeine. Besides this, electroencephalography, cerebral dopplers, heart rate variability and pain scores will be calculated before and after giving caffeine. This caffeine dose will be administered intravenously between 24 to 48 hours of life and an MRI will be done at days 9 to 14 of age.
|