| CTRI Number |
CTRI/2022/09/045696 [Registered on: 20/09/2022] Trial Registered Prospectively |
| Last Modified On: |
26/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
COMPARISON OF BLOOD FLOW IN BRAIN WITH BLOOD THICKNESS IN NEONATES AT RISK OF HAVING BLOOD THICKENING |
|
Scientific Title of Study
|
CEREBRAL BLOOD FLOW VELOCITY IN NEONATES AT RISK OF POLYCYTHEMIA AND ITS CORRELATION TO HEAMATOCRIT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranganath |
| Designation |
DCH, DNB PEDIATRICS |
| Affiliation |
Rainbow childrens hospital, Bangalore |
| Address |
Department of paediatrics Rainbow childrens hospital
Doddenakundi Marathahalli Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9972874332 |
| Fax |
|
| Email |
drranganath_a@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Babu S Madarkar |
| Designation |
MD DNB DM DNB MRCPCH MBA |
| Affiliation |
Rainbow childrens hospital, Bangalore |
| Address |
Department of paediatrics Rainbow childrens hospital Doddenakundi Marathahalli
Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9972874332 |
| Fax |
|
| Email |
babumadarkar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Ranganath |
| Designation |
DCH, DNB PEDIATRICS |
| Affiliation |
Rainbow childrens hospital, Bangalore |
| Address |
DEPARTMENT OF PEDIATRICS RAINBOW CHILDRENS HOSPITAL DODDENAKUNDI MARATHAHALLI BANGALORE
Bangalore
KARNATAKA
560037
India |
| Phone |
9972874332 |
| Fax |
|
| Email |
drranganath_a@ymail.com |
|
|
Source of Monetary or Material Support
|
| Rainbow childrens hospital, Marathahalli, Bangalore |
|
|
Primary Sponsor
|
| Name |
RAINBOW CHILDRENS HOSPITAL |
| Address |
Rainbow childrens hospital, Marathahalli, Bangalore |
| 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 Chandan C |
POST NATAL WARDS DEPARTMENT OF PAEDIATRICS |
Rainbow childrens hospital, Marathahalli, Bangalore
Bangalore Rural
KARNATAKA |
9448632142
chandan14462@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rainbow childrens hospital ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal newborn at risk of polyucythaemia |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
neonates with gestational age more than 35 weeks and having one or more risk factors for polycythemia which includes SGA, LGA, IDM, Post maturity, gestational hypertension, large twin of monochorionic twin |
|
| ExclusionCriteria |
| Details |
sick neonates requiring NICU admission, in whom consent is denied |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| to correlate PSV of ACA, MCA with hematocrit with neonate at risk of polycthemia |
PSV measured between 2 and 6 hour of life and one more time before discharge / after 36 hours of life
1st Haematocrit measured between 2 and 6 hour of life, subsequent Haematocrit measured after 36 hours/before discharge if Initial measured Haemotocrit is more than 65% |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare cerebral blood flow velocity, RI in neonates with polcythemia and normocythemia |
Cerebral blood flow velocity RI measured initially between 2 and 6 hour of life and subsequently after 36 hours of life/ before discharge |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2022 |
| Date of Study Completion (India) |
25/04/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
incidence of polycythemia is 1.5 to 45 of all live births. diagnosis of polycythemia requires venous hematocrit which is invasive. polycythemia is associated with altered cerebral hemodynamics. our efforts are to ascertain cerbral blood flow parameters in polycythemic babies for possible future implementation in clinical practice. .our objective is to correlate PSV of anterior and middle cerebral artery with hematocrit in neonates at risk of polycythemia. secondary objective is to compare cerebral blood flow velocity, RI in neonates with polycythemia and normocythemia. ours is a prospective observational study, babies with gestational age of more than 35weeks having risk factors of polycythemia will be enrolled in the study. free flow venous blood is sent for hematocrit measurement between 2 and 6 hours of life. repeat PCV is sent in the babies with prior value of PCV more than 65% at 36hrs of life /before discharge. PSV end diastolic velocity RI of MCA and ACA will be measured using Mindray portable ultrasound machine. with minicurved usg transducer. (8-13MHZ) |