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CTRI Number  CTRI/2022/01/039217 [Registered on: 06/01/2022] Trial Registered Prospectively
Last Modified On: 19/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of echocardiographic indices to predict how infants less than 28 days respond to intravenous fluid bolus in peri-operative period 
Scientific Title of Study   ASSESSMENT OF FLOW-BASED DYNAMIC INDICES TO PREDICT FLUID RESPONSIVENESS IN NEONATES 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mani Kiran Kasina 
Designation  Senior Resident 
Affiliation  PGIMER, Chandigarh 
Address  Department of Anaesthesia and Intensive care PGIMER
sector 12
Chandigarh
CHANDIGARH
160012
India 
Phone  9885202360  
Fax    
Email  dimond1989@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Preethy J Mathew 
Designation  Professor 
Affiliation  PGIMER 
Address  Department of Anaesthesia and Intensive Care, PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9417800203  
Fax    
Email  tjpreethy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Preethy J Mathew 
Designation  Professor 
Affiliation  PGIMER 
Address  Department of Anaesthesia and Intensive Care, PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9417800203  
Fax    
Email  tjpreethy@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh 
 
Primary Sponsor  
Name  Department of Anaesthesia and Intensive Care 
Address  PGIMER 
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 
Mani Kiran  PGIMER  Department of Anaesthesia and Intensive care
Chandigarh
CHANDIGARH 		 9885202360

dimond1989@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Late preterm (>34 weeks of gestational age) and term neonates upto 28 days of age scheduled for elective or emergency non-thoracic and non-cardiac surgeries 
 
ExclusionCriteria 
Details  Congenital heart disease
Cardiac arrhythmias
Neonates on inotropic and/ or vasoactive support
Pneumonia/ Atelectasis
Denial to participate in the study
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Respiratory variations in peak velocity of aortic blood flow   1. Baseline immediately after induction of anaesthesia. As a standard of care, an i.v. bolus of 10 ml/kg Ringers Lactate will be administered over 10 minutes after taking baseline measurement.
2. Second measurement will be done 2 minutes after end of i.v. fluid bolus  
 
Secondary Outcome  
Outcome  TimePoints 
Respiratory variations in velocity time integral of aortic blood flow and plethysmographic variablility index   1. Baseline immediately after induction of anaesthesia. As a standard of care, an i.v. bolus of 10 ml/kg Ringers Lactate will be administered over 10 minutes after baseline measurements.
2. Second measurements will be done 2 minutes after end of i.v. fluid bolus.  
 
Target Sample Size
Modification(s)  		 Total Sample Size="66"
Sample Size from India="66" 
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)   16/01/2022 
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   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  data can be made available by sending an email request to scientific query contact @ tjpreethy@gmail.com

  6. For how long will this data be available start date provided 01-01-2023 and end date provided 06-12-2021?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Administration of intravenous fluid boluses is a common intervention to treat perioperative hypotension. But, fluid administration may not always correct hypotension. Excessive intravenous fluid has many adverse affects. In quest of objective parameters to predict fluid responsiveness, static parameters like heart rate, blood pressure, central venous pressure and others failed to serve this purpose. Dynamic parameters, which are based on heart lung interaction are found to be useful in predicting fluid responsiveness in adults. Neonates physiology is different from adult population. So, we plan to conduct a study to validate the dynamic parameters viz. respiratory variation in aortic outflow, respiratory variation in velocity time integral of aortic flow  and plethysmography variability index to predict fluid responsiveness in neonates undergoing procedures under general anaesthesia. 
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