| CTRI Number |
CTRI/2025/11/097606 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Procedural Trial- Umbilical venous catheterization in newborns] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing birth weight and shoulder to umbilicus length for deciding umbilical venous catheter insertion depth in newborn babies |
|
Scientific Title of Study
|
A RANDOMISED CONTROL TRIAL TO ESTIMATE THE UMBILICAL VENOUS CATHETER INSERTION DEPTH IN NEWBORNS USING BIRTH WEIGHT VERSUS SHOULDER UMBILICAL LENGTH |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uma S Belvanki |
| Designation |
Postgraduate in Paediatrics |
| Affiliation |
Kempegowda Institute of Medical Sciences |
| Address |
Department of Paediatrics, Kempegowda Institute of Medical Sciences and Research Centre, Bengaluru, Karnataka
Bangalore
KARNATAKA
560004
India |
| Phone |
9632185131 |
| Fax |
|
| Email |
umasbelvanki@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SUNIL B |
| Designation |
Professor of Paediatrics |
| Affiliation |
Kempegowda Institute of Medical Sciences |
| Address |
Department of Paediatrics, Kempegowda institute of medical sciences Hospital and Research centre, Bengaluru, Karnataka
Bangalore
KARNATAKA
560004
India |
| Phone |
9900485879 |
| Fax |
|
| Email |
docsunilb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SUNIL B |
| Designation |
Professor of Paediatrics |
| Affiliation |
Kempegowda Institute of Medical Sciences |
| Address |
Department of Paediatrics, Kempegowda institute of medical sciences Hospital and Research centre, Bengaluru, Karnataka
Bangalore
KARNATAKA
560040
India |
| Phone |
9900485879 |
| Fax |
|
| Email |
docsunilb@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kempegowda Institute of Medical Sciences, Bengaluru |
|
|
Primary Sponsor
|
| Name |
Dr Uma S Belvanki |
| Address |
KIMS PG Resident quarters, KIMS hospital campus, KR road,Parvathipuram, Bengaluru |
| 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 Uma S Belvanki |
KIMS Hospital and Research centre, Bengaluru |
Neonatal Intensive care unit, Department of Paediatrics, 5th floor, A Block, Kempegowda institute of medical sciences, KR road, Parvathipuram, Bengaluru
Bangalore
KARNATAKA |
9632185131
umasbelvanki@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P969||Condition originating in the perinatal period, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Birth weight based formula for UVC insertion depth |
In this group, insertion length of the umbilical venous catheter will be calculated using a standard birth weight based formula (Shukla formula) and catheter will be inserted accordingly |
| Comparator Agent |
Shoulder umbilical length based formula for UVC insertion depth estimation |
In this group, insertion length of the umbilical venous catheter will be calculated using the measured shoulder umbilical length ( Dunns method) and catheter will be inserted accordingly |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
2.00 Day(s) |
| Gender |
Both |
| Details |
All preterm and term neonates requiring umbilical vein catheterization in KIMS NICU |
|
| ExclusionCriteria |
| Details |
Neonates with congenital anomalies like omphalocele, umbilical sepsis, congenital diaphragmatic hernia, necrotising enterocolitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of neonates with optimal umbilical venous catheter tip position at the inferior vena cava- right atrial junction, confirmed by chest X-ray |
Within 1 hour of insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Malposition rate ( hepatic vein, right atrium or other malpositions) confirmed on X ray |
Within 24 hours of insertion |
| Complications related to UVC insertion ( Arrhythmia, bleeding, perforation, thrombosis, infection ) |
Up to 7 days post insertion |
| Duration of catheter dwell and reason for removal |
At catheter removal |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
24/11/2025 |
| 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="1"
Months="6"
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
|
Accurate placement of umbilical venous catheter in neonates is crucial to ensure effective delivery of fluids, medications and parenteral nutrition. The optimal UVC tip position is at the inferior vena cava- right atrial junction. However predicting the appropriate insertion length remains challenging and different methods are in clinical use. 2 commonly practiced techniques are birth weight based formula ( Shukla and Ferrara formula) and shoulder umbilical length measurement (Dunns method). Both methods are widely used but have variable accuracy. This randomised control Trial aims to compare the accuracy of these 2 methods for estimating UVC insertion depth. Eligible neonates requiring UVC will be randomised in a 1:1 ratio to either birth weight based method or shoulder umbilical length method. In both group, calculated insertion length will be used during catherization and the tip position will be confirmed by Chest X ray. The primary outcome will be the proportion of neonates with catheter tip correctly positioned at the inferior vena cava - right atrial junction . Secondary outcomes include malpositions, catheter related complications, dwell time. This study will provide evidence regarding relative accuracy and safety of 2 commonly used methods for UVC insertion length estimation, with potential to inform Neonatal Intensive care practice and improve patient outcomes. |