| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Neonates admitted to Neonatal intensive care unit, |
|
|
Intervention / Comparator Agent
|
|
|
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. |