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CTRI Number  CTRI/2021/03/031894 [Registered on: 10/03/2021] Trial Registered Prospectively
Last Modified On: 24/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate the role of ultrasound guided umbilical venous catheter insertion vs Standard insertion i.e. without ultrasound in decreasing rate of misplacement of catheter tip in neonates. 
Scientific Title of Study   Ultrasound guided umbilical venous catheter insertion to reduce rate of catheter tip malposition 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  Dr Amandeep Kaur 
Designation  DM Resident - Neonatology 
Affiliation  Lokmanya Tilak Municipal College and General Hospital, Sion, Mumbai 
Address  Room no 123, Department of Neonatology, First Floor, Lokmanya Tilak Municipal College and General Hospital, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  8727088015  
Fax    
Email  amans2488@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swati Manerkar 
Designation  Additional Professor/HOD Neonatology 
Affiliation  Lokmanya Tilak Municipal College and General Hospital, Sion, Mumbai 
Address  Room no 123, Department of Neonatology, First Floor, Lokmanya Tilak Municipal College and General Hospital, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  9769997968  
Fax    
Email  drswatimanerkar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amandeep Kaur 
Designation  DM Resident - Neonatology 
Affiliation  Lokmanya Tilak Municipal College and General Hospital, Sion, Mumbai 
Address  Room no 123, Department of Neonatology, First Floor, Lokmanya Tilak Municipal College and General Hospital, Sion, Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  8727088015  
Fax    
Email  amans2488@gmail.com  
 
Source of Monetary or Material Support  
Lokmanya Tilak Municipal College and General Hospital, Sion, Mumbai 
 
Primary Sponsor  
Name  Lokmanya Tilak Municipal College and General Hospital Sion Mumbai 
Address  Lokmanya Tilak Municipal College and General Hospital, Sion, Mumbai 
Type of Sponsor  Government medical college 
 
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 Amandeep Kaur  Lokmanya Tilak Municipal College and General Hospital, Sion, Mumbai  Room no 123, Department of Neonatology, First Floor, Lokmanya Tilak Municipal College and General Hospital, Sion, Mumbai
Mumbai
MAHARASHTRA 		 8727088015

amans2488@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Human Research, LTMMC and GH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P073||Preterm [premature] newborn [other],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard   In standard umbilical venous catheter insertion, the catheter is inserted without ultrasound guidance and then tip position checked with an X ray. 
Intervention  Ultrasound  Ultrasound guided umbilical venous catheter insertion 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  7.00 Day(s)
Gender  Both 
Details  All neonates admitted in NICU requiring umbilical venous catheter insertion within 1st week of life will be included.  
 
ExclusionCriteria 
Details  Major congenital anomalies of thorax and abdomen 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary objective is the reduction in the catheter tip malposition rates when catheter insertion done ultrasound guidance in neonates admitted in NICU. Optimal position on radiograph is defined when it is placed between T8 and T10 on radiograph and on USG where the catheter tip is in the IVC between the hepatic veins confluence and right atrium opening. A vertebral landmark of T8 to T10 corresponds to the vena cava right atrial junction in 90 percent of the neonates  Immediate 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in number of catheter repositioning required  Immediate 
To compare accuracy of ultrasound with radiograph (current gold standard) in determining catheter tip position.  Immediate 
Time taken for the completion of procedure in both groups  Immediate 
Role of catheter insertion by manoeuvre of aligning the umbilical vein and ductus venosus as described by Kishigami et al  Immediate 
Position of catheter tip when malpositioned in both groups  Immediate 
Rate of malposition in groups stratified according to weight  Immediate 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/03/2021 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is an open, randomised, parallel group, single centre trial with aim to compare whether umbilical venous catheter insertion under ultrasound guidance reduces rate of catheter tip malposition rates compared to standard insertion followed by radiograph in neonates admitted in NICU. Primary objective is reduction in catheter tip malposition rates when catheter insertion done by ultrasound guidance in neonates admitted in NICU. In the secondary objectives we will also see if it leads to reduction in number of catheter tip repositioning required, time taken to insert catheter in both groups, to compare accuracy of ultrasound compared to radiograph in determining catheter tip position. Catheter tip if malpositioned will be noted and any effect of weight on rate of malposition will also be noted. 
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