| CTRI Number |
CTRI/2023/05/053253 [Registered on: 30/05/2023] Trial Registered Prospectively |
| Last Modified On: |
28/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to see whether umbilical venous catheter (uvc) or peripherally inserted central catheter (picc)is better to reduce neonatal sepsis in low birth weight babies in NICU |
|
Scientific Title of Study
|
Comparison of uvc with picc for reducing neonatal sepsis in low birth weight babies IN nicu:a randomised 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 |
Goli Murali Krishna |
| Designation |
Junior Resident |
| Affiliation |
MGM medical college , Aurangabad |
| Address |
department of paediatrics ,3rd floor MGM medical college Aurangabad Maharashtra
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8499050709 |
| Fax |
|
| Email |
murali7828@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil gavhane |
| Designation |
associate proffessor,head of NICU |
| Affiliation |
MGM medical college , Aurangabad |
| Address |
ROOM NO 1st floor,NICU,MGM Medical college, N6 CIDCO AURANGABAD MAHARASHTRA 431003
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9158675555 |
| Fax |
|
| Email |
drsunildg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Goli Murali krishna |
| Designation |
junior resident |
| Affiliation |
MGM medical college , Aurangabad |
| Address |
department of paediatrics ,3rd floor MGM medical college Aurangabad Maharashtra
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8499050709 |
| Fax |
|
| Email |
murali7828@gmail.com |
|
|
Source of Monetary or Material Support
|
| mgm medical college ,aurangabad |
|
|
Primary Sponsor
|
| Name |
Goli Murali Krishna |
| Address |
third floor,department of paediatrics, Aurangabad |
| 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 |
| goli murali krishna |
MGM Medical College |
NICU 1st floor MGM medical college,aurangabad
Aurangabad
MAHARASHTRA |
8499050709
murali7828@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGMECRHS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P369||Bacterial sepsis of newborn, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
umbilical venous catheter(uvc) and peripherally inserted central catheter (picc) |
to compare umbilical venous catheter (uvc) and peripherally inserted central catheter(picc) |
| Intervention |
sepsis |
to reduce sepsis by using umbilical venous catheter and peripherally inserted central catheter |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
LOW BIRTH WEIGHT BABIES ADMITTED TO NICU REQUIRING ATLEAST 5DAYS OF CENTRAL LINE ACCESS |
|
| ExclusionCriteria |
| Details |
NEWBORN WITH LOCAL SITE INFECTION,BLOOD CULTURE POSITIVE BEFORE CENTRAL LINE INSERTION |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| IMPACT OF UMBILICAL VENOUS CATHETER AND PERIPHERALLY INSERTED CENTRAL CATHETER ON NEONATAL SEPSIS |
ASSESSED FROM TIME OF ADMISSION TILL DISCHARGE OR DEATH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| document complications like retinopathy of prematurity,necrotizing enterocolitis,localsite infection,line blockage,cardiac tamponade,line breakdown,feedintolerance. |
after insertion of central line till discharge or death |
|
|
Target Sample Size
|
Total Sample Size="162"
Sample Size from India="162"
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)
|
05/06/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NO |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
to compare umbilical venous catheter and peripherally inserted central catheter for reducing neonatal sepsis in low birth weight babies in NICU mgm medical college,aurangabad. primary objective:impact of umbilical catheter and peripherally inserted central catheter in reducing neonatal sepsis. secondary objectuve:to document complications like necrotising enterocolitis,line blockage,line displacement,cardiac tamponade,pericardial effusion. |