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CTRI Number  CTRI/2017/07/009104 [Registered on: 26/07/2017] Trial Registered Retrospectively
Last Modified On: 22/12/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective Observational study 
Study Design  Single Arm Study 
Public Title of Study   Normal values of cerebral blood flow velocities in stable infants less than 1500 g during first month of life. 
Scientific Title of Study   Normative values of cerebral blood flow velocities in stable Very Low Birth Weight infants during first month of life 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bharat Kansal 
Designation  MBBS MD 
Affiliation  Sir Gangaram Hospital 
Address  Department of Neonatology, Sir Gangaram Hospital Old Rajender Nagar New Delhi
Dept Of Neonatology Sir Gangaram hospital Old Rajender Nagar New Delhi-110060
New Delhi
DELHI
110060
India 
Phone  9742336747  
Fax    
Email  drbharatkansal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anup Thakur 
Designation  MBBS MD DNB (Neonatology) 
Affiliation  Sir Gangaram Hospital 
Address  Department of Neonatology, Sir Gangaram Hospital Old Rajender Nagar New Delhi
Department of Neonatology, Sir Gangaram Hospital Old Rajender Nagar New Delhi
New Delhi
DELHI
110060
India 
Phone  8800565956  
Fax    
Email  dr.thakuranup@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anup Thakur 
Designation  MBBS MD DNB (Neonatology) 
Affiliation  Sir Gangaram Hospital 
Address  Department of Neonatology, Sir Gangaram Hospital Old Rajender Nagar New Delhi
Department of Neonatology, Sir Gangaram Hospital Old Rajender Nagar New Delhi
New Delhi
DELHI
110060
India 
Phone  8800565956  
Fax    
Email  dr.thakuranup@gmail.com  
 
Source of Monetary or Material Support  
none 
 
Primary Sponsor  
Name  Sir Gangaram Hospital 
Address  Department of Neonatology Sir Gangaram hospital New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Bharat Kansal  Sir Gangaram Hospital  Department of Neonatology, Sir Gangaram Hospital Old Rajender Nagar- New Delhi -110060
New Delhi
DELHI 
9742336747

drbharatkansal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Sir Gangaram hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P019||Newborn affected by maternal complication of pregnancy, unspecified, Stable babies with birth weight less than 1500gms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All infants less than 1500 gram who are hemodynamically stable, defined as having a resting HR between 120 and 180 per min, SPO2 >85%, CFT <3 sec and mean BP above 10th centile for gestation specific normogram. 
 
ExclusionCriteria 
Details  1) Infants with gross congenital malformations.
2) Infants requiring extensive resuscitation-chest compression or medications at birth.
3) Infants on mechanical ventilation with mean airway pressure (MAP) >12 mbar.
4) Infants requiring inotropes.
5) Infants with intraventricular hemorrhage of Grade II or higher (Papile classification)  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To measure Cerebral blood velocities of Anterior cerebral, Middle cerebral and basilar arteries  2-8 hours of life
24 hours,3 days,7 days,14 days and 28 days/ or at the time of discharge. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   14/07/2017 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Title- Normative values of cerebral blood flow velocities in stable Very Low Birth Weight infants during first month of life.

Very Low Birth Weight (VLBW) infants undergo a dramatic change in hemodynamics during transition in the early neonatal period. Knowledge of postnatal age specific normative data on cerebral blood flow during first few weeks of life might be valuable and may help in early identification of abnormal adaptation. Besides this, cerebral blood flow changes can be detected before clinical decompensation of circulatory response occurs. However before attempting to interpret changes in acute diseased states, it is imperative to understand normal changes in cerebral blood flow in neonates. Longitudinal data on changing cerebral hemodynamics after birth are still lacking. There is a need to define gestation specific longitudinal data on cerebral blood flow indices in hemodynamically stable VLBW infants. We plan to conduct an observational study to determine normative values of cerebral blood flow velocities in anterior cerebral artery, middle cerebral artery and basilar artery in stable VLBW infants in the first month of life (at 2-8 hours, 24 hours, 3 days, 7 days, 14 days and 28 days or at the time of discharge).

 
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