FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/04/013126 [Registered on: 09/04/2018] Trial Registered Retrospectively
Last Modified On: 23/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   prospective randomized 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ultrasound guided insertion of umbilical catheters in neonates 
Scientific Title of Study   Comparative study on point of care ultrasound with radiography in umbilical catheter tip confirmation 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  Surjeet Singh 
Designation  DNB trainee 
Affiliation  Manipal Hospital, Bangaluru 
Address  Department of Neonatology Manipal Hospital old airport road Bangaluru

Bangalore
KARNATAKA
560017
India 
Phone  9783592025  
Fax    
Email  drsurjeetsingh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  HA Venkatesh 
Designation  Consultant and Head of department 
Affiliation  Manipal Hospital, Bangaluru 
Address  Department of Neonatology Manipal Hospital 98, HAL old airport road,Kodihalli Bangaluru

Bangalore
KARNATAKA
560017
India 
Phone  9980135300  
Fax    
Email  venkatveena46@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Surjeet Singh 
Designation  DNB trainee 
Affiliation  Manipal Hospital, Bangaluru 
Address  Department of Neonatology Manipal Hospital old airport road Bangaluru

Bangalore
KARNATAKA
560017
India 
Phone  9783592025  
Fax    
Email  drsurjeetsingh@gmail.com  
 
Source of Monetary or Material Support  
Manipal Hospital 98, HAL Old airport road Kodihalli, Bangalore karnataka 560017 
 
Primary Sponsor  
Name  Surjeet Singh 
Address  Manipal Hospital 98, HAL old airport road Kodihalli, Bangalore, Karnataka 560017 
Type of Sponsor  Other [Self] 
 
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 
Surjeet Singh  Manipal Hospital,Bangalore  Department of Neonatology 98,HAL Old Airport Road Kodihalli, Bangalore
Bangalore
KARNATAKA 
9783592025

drsurjeetsingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of manipal Hospital,bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Neonates admitted to Neonatal intensive care unit,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Neonates admitted to neonatal intensive care unit requiring umbilical catheter placement as part of intensive management  
 
ExclusionCriteria 
Details  Neonates with major congenital anomalies involving abdomen and thorax. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparison of following parameter between USG and radiography in determination of position of umbilical catheters
1.Time taken to determine
2.Number of X-rays taken
3.Number of manipulations
 
Measurement will be taken on a single time assessment 
 
Secondary Outcome  
Outcome  TimePoints 
No secondary outcomes  Nil 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   01/10/2017 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   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)?  

Brief Summary  

Umbilical vein and umbilical artery catheterization may be a life-saving procedure in neonates who require vascular access and resuscitation.  The umbilical vein remains patent and viable for cannulation until approximately 1 week after birth.   After proper placement of the umbilical line, intravenous (IV) fluids and medication may be administered to critically ill neonates.  In standard care optimal position of umbilical catheters after insertion is confirmed by radiography.  This method is time consuming and exposes the newborn to radiation. In this Study we set to find a more efficient and accurate method for determining optimal umbilical catheter position using bedside ultrasound.  In this study we will include neonates requiring umbilical catheter placement as a part of intensive management.  Umbilical catheter tip determination will be done at the time of procedure using bedside ultrasound.  Comparison group will be standard care group which include radiography.

In this study, we will seek to determine bedside ultrasound as a time-efficient and accurate mean of umbilical catheter placement and tip confirmation.


 
Close