| CTRI Number |
CTRI/2025/07/091999 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Randomised Controlled Trial] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Early removal and delayed removal of umbilical vein cathetar to prevent sepsis in low birth weight neonates |
|
Scientific Title of Study
|
Early removal and delayed removal of umbilical vein cathetar to prevent sepsis in low birth weight neonates: Randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MGM-ECRHS/PEDIATRIC/MD/2024/01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Apeksha Rajeardad |
| Designation |
Junior Resident |
| Affiliation |
MGM Medical College and Hospital, Aurangabad |
| Address |
MGM Medical College and Hospital, N5, Town Centre, Cidco, Aurangabad, Maharashtra-431001
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
8108033340 |
| Fax |
|
| Email |
apeksha.raje98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Subhash Dhule |
| Designation |
Associate Professor |
| Affiliation |
Department of Paediatrics, MGM Medical College and Hospital, Aurangabad |
| Address |
MGM Medical college and hospital, N5,Town centre,CIDCO, Aurangabad.
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7083815584 |
| Fax |
|
| Email |
drsachindhule@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Subhash Dhule |
| Designation |
Associate Professor |
| Affiliation |
Department of Paediatrics, MGM Medical College and Hospital, Aurangabad |
| Address |
MGM Medical college and hospital, N5,Town centre,CIDCO, Aurangabad.
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7083815584 |
| Fax |
|
| Email |
drsachindhule@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Medical college and hospital, N5,Town centre,CIDCO, Aurangabad, Maharashtra 431001. India. |
|
|
Primary Sponsor
|
| Name |
Dr Apeksha Rajeardad |
| Address |
MGM Medical college and hospital, N5,Town centre,CIDCO, Aurangabad, Maharashtra 431001. India. |
| 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 |
| Dr Apeksha Rajeardad |
MGM Medical College and Hospital |
Department of Pediatrics, MGM Medical college and hospital, N5,Town centre,CIDCO, Aurangabad, Maharashtra 431001. India.
Aurangabad
MAHARASHTRA |
08108033340
apeksha.raje98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM-Ethics Committee for Research on Human Subjects(ECRHS)) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P84||Other problems with newborn, (2) ICD-10 Condition: O601||Preterm labor with preterm delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
All low birth weight neonates admitted in NICU requiring atleast 5-7 days of central line. |
|
| ExclusionCriteria |
| Details |
Neonates that flagged culture positive before catheterisation, neonates with fallen umbilical cord, Neonates with local site infection or other conditions like NEC,Peritonitis, Gastrochisis, Omphalocele, etc |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) To calculate the effects of both early and delayed umbilical vein cathetar removal in preventing sepsis in neonates with low birth weights |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) To assess the evidence of localized infection in early versus delayed removal of umbilical vein catheter. |
2 years |
| To estimate the risk of development of Necrotising Colitis with various dwell times of umbilical vein cathetars. |
2 years |
| To assess the evidence of line blockage with various dwell times of umbilical vein cathetars. |
2 years |
| To measure time taken to achieve full feeds in various umbilical line dwell time settings. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
09/08/2025 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a single centre, Parallel group , Randomised controlled trial which the effect of early and delayed removal of umbilical vein cathetar on sepsis in low birth weight neonates will be compared. Patients will be recruited in two parallel groups and the effect of the dwell time of the cathetar on incidence of sepsis will be compared. This study would be helpfull so as to what should be the dwell time of the cathetar to prevent sepsis in low birth weight infants. |