| CTRI Number |
CTRI/2024/06/069432 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
21/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Establishment of the normal data about blood flow to brain (hemodynamics) in healthy babies in first 2 days of life. |
|
Scientific Title of Study
|
A cross sectional study to establish the normative data of cerebral hemodynamics by point of care cranial ultrasound(POCUS) in healthy neonates more than or equal to 34 weeks of gestation in early postnatal period. |
| 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 Pardha Ramineni |
| Designation |
DM Senior Resident |
| Affiliation |
Bharati Vidyapeeth Deemed University Medical College , Pune |
| Address |
NICU room, 2nd Floor,Department of Neonatology, Division of ICU Bharati HospitaL and Research Centre, Dhanakawadi, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9866972307 |
| Fax |
|
| Email |
drpardharamineni2307@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suprabha Patnaik |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth Deemed University Medical College , Pune |
| Address |
NICU ROOM, 2nd Floor ,Department of Neonatology, Division of ICU, Bharati HospitaL and Research Centre, Dhanakawadi, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9866972307 |
| Fax |
|
| Email |
suprabha.patnaik@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pardha Ramineni |
| Designation |
DM Senior Resident |
| Affiliation |
Bharati Vidyapeeth Deemed University Medical College , Pune |
| Address |
NICU room, 2nd Floor,Department of Neonatology, Division of ICU Bharati HospitaL and Research Centre, Dhanakawadi, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9866972307 |
| Fax |
|
| Email |
drpardharamineni2307@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed University Medical College, Pune , Maharasthra, India
Pin code: 411043 |
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth Deemed University Medical College Pune |
| Address |
Dhanakawadi,Katraj, Pune , Maharashtra , India
Pincode : 411043 |
| Type of Sponsor |
Private 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 Pardha Ramineni |
Bharati Hospital and Research Centre |
NICU and Post Natal rooms , 1st and 2nd floor,Department of Neonatology, Division of ICU Bharati Hospital and research Centre , Dhanakawadi
Pune
MAHARASHTRA |
9866972307
drpardharamineni2307@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed to be UniversityMedical College Institutional Ethics Commiittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Intraventicular hemorrhage, Hydrocephalus , Perinatal asphyxia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
2.00 Day(s) |
| Gender |
Both |
| Details |
All healthy neonates more than or equal to 34 weeks of gestation |
|
| ExclusionCriteria |
| Details |
Neonates requiring respiratory support
Hemodynamically unstable neonates requiring inotropes
Any neonate requiring positive pressure ventilation for more than 60 seconds
Major congenital malformation
Sepsis
Outborn neonates admitted in Unit
Parents not consenting for participation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish cerebral blood flow velocities and resistive indices of healthy term and late preterm neonates within 48 hours of life |
48 hours of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the anterior cerebral blood flow velocities and resistive indices among healthy Appropriate for gestational age (AGA) and Small for gestational age (SGA) neonates more than or equal to 34 weeks of gestation |
48 hours of life |
| To compare the anterior cerebral blood flow velocities and resistive indices among healthy neonates of more than or equal to 34 weeks of gestation with and without fetal growth restriction |
48 hours of life |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/07/2024 |
| 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="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
|
Th study is being done to establish normative data regarding cerebral blood flow hemodynamics in healthy neonates equal to or more than 34 weeks of gestation in the early first 48 hours of postnatal period. It also aims to compare and note any difference of cerebral hemodynamics between SGA & AGA babies as well as IUGR babies |