| CTRI Number |
CTRI/2020/09/027935 [Registered on: 21/09/2020] Trial Registered Prospectively |
| Last Modified On: |
12/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the usefulness of ultrasound in umbilical venous catheter insertion in neonates admitted in NICU. |
|
Scientific Title of Study
|
Comparison of Ultrasound guided umbilical insertion with conventional method- A randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Purbasha Mishra |
| Designation |
Senior resident, DM Neonatology |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
NICU, 2nd floor
Hospital building
AIIMS Bhubaneswar
Sijua, patrapada
Dr Pankaj Mohanty
Associate professor
Department of Neonatology
Room no 19, 5th floor, faculty block
Hospital building
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
8284825799 |
| Fax |
|
| Email |
purbimishra25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kumar Mohanty |
| Designation |
Associate professor, Department of Neonatology |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Dr Pankaj Kumar Mohanty
Associate professor
Department of Neonatology
Room no 19, 5th floor, faculty block
Hospital building
AIIMS Bhubaneswar
NICU
Department of Neonatology
2nd floor
Hospital building
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9078823780 |
| Fax |
|
| Email |
neonat_pankaj@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Purbasha Mishra |
| Designation |
Senior resident, DM Neonatology |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
NICU, 2nd floor
Hospital building
AIIMS Bhubaneswar
Sijua, patrapada
Dr Pankaj Mohanty
Associate professor
Department of Neonatology
Room no 19, 5th floor, faculty block
Hospital building
AIIMS Bhubaneswar
ORISSA
751019
India |
| Phone |
8284825799 |
| Fax |
|
| Email |
purbimishra25@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Purbasha Mishra |
| Address |
NICU, AIIMS BHUBANESWAR
HOSPITAL BUILDING |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Pankaj Mohanty |
Room no 19, faculty block, 5th floor hospital building
AIIMS Bhubaneswar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrPurbasha Mishra |
AIIMS Hospital |
Neonatal intensive care unit
2nd floor, hospital building
AIIMS Bhubaneswar
Sijua, patrapada
Sijua, Patrapada
Pin 751019
Khordha
ORISSA |
8284825799
purbimishra25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,AIIMS,BHUBANESWAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P119||Birth injury to central nervous system, unspecified, (2) ICD-10 Condition: P018||Newborn affected by other maternalcomplications of pregnancy, (3) ICD-10 Condition: P073||Preterm [premature] newborn [other], (4) ICD-10 Condition: P229||Respiratory distress of newborn, unspecified, (5) ICD-10 Condition: P922||Slow feeding of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional method |
Umbilical catheter is inserted blindly by looking the anatomy and identification of umbilical vein and tip position is confirmed with xray |
| Intervention |
Ultrasound guided umbilical venous catheter insertion |
Ultrasound will be used to visualise the anatomy and insert the umbilical catheter, tip position will be first seen by ultrasound and then confirmed by xray |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All terms/preterm with prolonged intravascular access for the following conditions
1. Babies on mechanical ventilation for respiratory failure, mechanical asphyxia
2. Total parenteral nutrition
3. Shock
4.hypoglycemia with GIR>12.5%
5.IV fluids for surgical indications |
|
| ExclusionCriteria |
| Details |
1.Congenital anomalies of abdominal wall
2. Necrotizing enterocolitis
3. Peritonitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the failure rates of usg guided umbilical venous catheter (UVC)insertion with the conventional method |
Reduction in failure rate assessed after18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare USG with X-ray in determining the tip position of UVC |
18 months |
| To calculate the time taken for USG and calculate the time difference between USG and radiograph |
18 months |
| To observ complications with UVC insertion |
18 months |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
22/09/2020 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Results will be mentioned after trial is completed and analysis done. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a open label randomized parallel group trial comparing ultrasound guided umbilical venous catheter insertion with conventional(blind) insertion. Trial will be conducted in preterm/term neonates who are admitted in NICU and require prolonged intravascular access. The primary outcome is to compare the failure rates of Ultrasound guided UVC insertion with the conventional method. The secondary outcomes are comparison of tip position of UVC with X-ray, to observe the complications with UVC insertion and to calculate the time difference between ultrasound and X-ray for completion of the procedure. Analysis will be done at the end of 18 months. |