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CTRI Number  CTRI/2023/12/060566 [Registered on: 20/12/2023] Trial Registered Prospectively
Last Modified On: 18/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   DIAGNOSTIC TEST 
Study Design  Other 
Public Title of Study   Studying How Perfusion Index Relates to Superior Vena Caval Flow and Assessing the Plethysmography Variability Index as an Early Indicator of Fluid-Responsive Shock in Newborns Under 72 Hours in a Tertiary Neonatal Unit. 
Scientific Title of Study   Correlation of Perfusion Index with Superior Vena Caval flow and Utility of Plethysmography Variability Index as Early Predictor of fluid responsive Shock in sick newborn of less than 72 hrs age in a Tertiary Care Neonatal Unit 
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 Bijan Saha 
Designation  Associate Professor 
Affiliation  Institute of Post-Graduate Medical Education and Research and SSKM Hospital 
Address  Department of Neonatology Institute of Post-Graduate Medical Education and Research and SSKM Hospital Kolkata-700020 India

Kolkata
WEST BENGAL
700020
India 
Phone  9051389120  
Fax    
Email  bijansaha18@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bijan Saha 
Designation  Associate Professor 
Affiliation  Institute of Post-Graduate Medical Education and Research and SSKM Hospital 
Address  Department of Neonatology Institute of Post-Graduate Medical Education and Research and SSKM Hospital Kolkata-700020 India

Kolkata
WEST BENGAL
700020
India 
Phone  9051389120  
Fax    
Email  bijansaha18@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sougoto Chowdhury 
Designation  Assistant Professor 
Affiliation  Institute of Post-Graduate Medical Education and Research and SSKM Hospital 
Address  Department of Neonatology Institute of Post-Graduate Medical Education and Research and SSKM Hospital Kolkata-700020 India

Kolkata
WEST BENGAL
700020
India 
Phone  9477036563  
Fax    
Email  saugata.dr@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENTAL FUNDING 
 
Primary Sponsor  
Name  DEPARTMENT OF NEONATOLOGY 
Address  DEPARTMENT OF NEONATOLOGY IPGMER AND SSKM HOSPITAL KOLKATA 
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 
Dr Bijan Saha  NICU Department of neonatology  DEPARTMENT OF NEONATOLOGY IPGMER AND SSKM HOSPITAL KOLKATA
Kolkata
WEST BENGAL 
9051389120

bijansaha18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I999||Unspecified disorder of circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NO COMPARATOR AS PROSPECTIVE OBSERVATIONAL STUDY  Study of perfusion index as predictor of shock 2. To find correlation between Perfusion index and SVC flow 3. Study of PVI as a predictor of fluid responsive shock 
Intervention  perfusion index  Study of perfusion index as predictor of shock 2. To find correlation between Perfusion index and SVC flow 3. Study of PVI as a predictor of fluid responsive shock  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  sick neonates of less than 72hrs of age admitted in the NICU 
 
ExclusionCriteria 
Details  major congenital anomalies,congenital heart disease 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
. Study of perfusion index as predictor of shock
2. To find correlation between Perfusion index and SVC flow
3. Study of PVI as a predictor of fluid responsive shock
 
For all recruited babies, every 8th hourly, from the time of recruitment till 48 hrs. In babies with shock , every 20 minutes till perfusion is normal and thereafter as scheduled.
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To find correlation between the Perfusion index and SVC flow 2. Study of PVI as a predictor of fluid responsive shock  For all recruited babies, every 8th hourly, from the time of recruitment till 48 hrs. In babies with shock , every 20 minutes till perfusion is normal and thereafter as scheduled.
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   29/12/2023 
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 Applicable 
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  

                                                               

 

METHODOLOGY

STUDY DESIGN = Prospective observational study (diagnostic test)

MATERIAL & METHODS

Inclusion Criteria: Sick neonates  less than 72 hours of age  admitted in the  department of neonatology who need hemodynamic monitoring

 Exclusion Criteria: Major Congenital Anomaly, Congenital Heart disease.

Sample Size : Convenient sample for 1 year according to the nicu admission rate of sick newborn less than 72 hours of age 

PROCEDURE :

All  neonates less than 72 hours of age   admitted in the NICU  will be analyzed by SNAPPE II score.  Neonate with  Score ≥ 38 will be enrolled for study after obtaining consent  from parents. After recruitment, baseline data will be  entered in data entry form.

.Hemodynamic monitoring will be  done by investigators for the recruited neonates for 48 hours from the time of enrollment.

The monitoring will include the following clinical parameters: Heart Rate, Pulse rate, capillary refill time, cold extremities. SVC flow will be  measured by echocardiography. Recording of PI and PVI will be done by  pulse oximeter.

TIME SCHEDULE FOR MONITORING:

 For all recruited babies, every 8th  hourly, from the time of recruitment till 48 hrs. In  babies with shock , every 20 minutes till perfusion is normal and thereafter as scheduled.

 Heart rate monitoring: Done by investigator uses stethoscope when baby is not agitated Extremities cold to touch: Using dorsum of the hand to feel temperature on abdomen and feet. If both are warm, then the baby is normothermic and if the abdomen is warm and the foot is cold, then the baby is in cold stress or shock.

  Pulse volume measurement:

Central pulse- The volume of brachial pulse and femoral pulse

 Peripheral pulse-The volume of radial pulse and posterior tibial pulse

Capillary refill time: After application of pressure on chest for 3-5 seconds,time taken for return of colour would be assessed.

Blood pressure measurement: It is measured in a supine position with appropriate size cuff in a quiet environment in the right upper limb,when the baby is not agitated[14]. The width of the cuff being 60-70% of the arm length.

PI recording: It will be  obtained from recording of pulse oximeter having  signal extraction technology.Measurement will be  taken from the right upper limb after application of pulse oximeter probe, when limb is at rest and without agitation. Masimo Monitor would be  used.

PVI : Using PI, PVI is calculated according to equation

PVI = PI max – PI min   / PI max     X  100 %

 

 

SVC flow measurement: By following formula : SVC flow(ml/kg/min)=[{pi*(mean SVC D/2)2 (cm)2}*VTI(cm)*HR(BPM)]/BODY WEIGHT(KG) SVC internal diameter  measured in 2d mode echocardiography at the point the SVC starts to open up into RA and a mean of maximum and minimum diameter within the cardiac cycle would be  used for calculation of the flow[[i]].

SVC VTI will be measured with pulse doppler tracing in subcostal view with box positioned at the junction of SVC and RA[18]with an angle <15 degree. The mean velocity of blood flow will be averaged from 5 consecutive cardiac cycles. GE Vivid S60N Echocardiographic machine will be used.

 

 Clinical criteria to define shock or poor perfusion:

 Weak and fast pulse( >180 bpm)

Capillary refill time >3 sec

Cold extremities with or without following :  pale, lethargy, not arousable on stimulation

STATISTICAL ANALYSIS : We plan to compute the linear dependency among two variables using Pearson product movement correlation and use a statistical test to check the significance of the linear correlation .We then fit a linear regression model to predict the response variable for a given covariate. .To identify the effect of covariate on the different quantiles of the response variable,we also plan to use “linear quantile regression”for predicting different quantiles of the response variable .All the computed results will be reported by the function of statistical software ‘R’.

 

Ethical Consideration :

The project will be started after obtaining permission from Scientific and Ethical committee.

Funding – No

 
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