Estimating Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body Measurements: A Multicenter Randomized Clinical Trial

NCT07045506 | Completed DMC

• 1 other identifier: 21-542
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: The current methods for estimating umbilical venous catheter (UVC) insertion depth, including the umbilical to nipple (Gupta) and the birth weight-based (modified Shukla) formula, have varying accuracy rates. Objectives: To compare the accuracy of UVC insertion length using the birth weight-based formula versus the surface measurement formula in determining the optimal UVC tip position. Methods: A multicenter randomized clinical trial was conducted in the neonatal intensive care units (NICUs) of the Second Cluster in Al Riyadh (AL Yamama Hospital and King Fahad Medical City), King Salman Armed Forces Hospital in the Northwestern Region, Tabuk City, Saudi Arabia. Neonates requiring UVC insertion during their NICU admission were randomly assigned to one of two formulas: 1) the umbilicus to nipple distance in centimeters minus 1 (UN - 1) or 2) the modified Shukla weight-based formula in centimeters (3 × birth weight in kg + 9, divided by 2) to estimate the pre-insertion UVC depth and to determine the UVC tip position anteroposterior and lateral thoracoabdominal radiographs were taken and reviewed by a neonatologist, who was blinded to the group assignments. Data analysis was conducted using appropriate statistical methods, ensuring adherence to ethical standards.

Conditions

Estimating Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body Measurements

Keywords

umbilical venous catheter ( UVC) , catheter placement, Gupta method, birth weight-based formula, neonatal intensive care unit, clinical trial,

Outcome Measures

Primary Outcomes (1)

• Proportion of correctly inserted UVC at optimum catheter tip position for each method

  Within 48 Hours

Study Arms (2)

Group 1 UVC insertion depth estimated using the Umbilicus to Nipple distance (UN) minus 1

ACTIVE COMPARATOR

Neonates who met the eligibility criteria were randomly assigned to one of two groups. Group 1 had their UVC insertion depth estimated using the Umbilicus to Nipple distance (UN) minus 1 cm formula (Gupta method), while Group 2 used the birth weight formula (3\*wt +9)/2 (modified Shukla). Randomization was achieved using a computer-generated sequence, with allocation in blocks of four. The neonates were randomized in a 1:1 ratio. Initially, 184 infants were assessed for eligibility to participate in the study. Of these, 4 were excluded due to refusal to participate. The remaining 180 infants were randomly assigned to one of two intervention groups (the Gupta group or the modified Shukla group) in a 1:1 ratio. All infants in both groups received the allocated intervention, with no cases lost to follow-up or discontinuation of the intervention.

Other: UVC insertion

Group 2 UVC insertion used the birth weight formula (3*wt +9)/2 (modified Shukla)

ACTIVE COMPARATOR

Neonates who met the eligibility criteria were randomly assigned to one of two groups. Group 1 had their UVC insertion depth estimated using the Umbilicus to Nipple distance (UN) minus 1 cm formula (Gupta method), while Group 2 used the birth weight formula (3\*wt +9)/2 (modified Shukla). Randomization was achieved using a computer-generated sequence, with allocation in blocks of four. The neonates were randomized in a 1:1 ratio. Initially, 184 infants were assessed for eligibility to participate in the study. Of these, 4 were excluded due to refusal to participate. The remaining 180 infants were randomly assigned to one of two intervention groups (the Gupta group or the modified Shukla group) in a 1:1 ratio. All infants in both groups received the allocated intervention, with no cases lost to follow-up or discontinuation of the intervention.

Other: UVC insertion

Interventions

UVC insertion OTHER

UVC insertion was performed under sterile conditions according to the unit protocol by a senior NICU physician. For preterm deliveries, written informed consent was obtained from a parent before enrollment in the study. In emergency cases, where the neonate required immediate UVC insertion upon admission to the NICU, a waiver of informed consent was applied. In such instances, parents were informed as soon as possible about their infant's participation in the study, provided with written information, and asked for their consent to include their infant's data in the analysis, with the option to give consent via telephone if they were unable to be present in person. After UVC insertion, anteroposterior and lateral thoracoabdominal radiographs were performed to verify the position of the UVC tip.

Group 1 UVC insertion depth estimated using the Umbilicus to Nipple distance (UN) minus 1; Group 2 UVC insertion used the birth weight formula (3*wt +9)/2 (modified Shukla)

Eligibility Criteria

• Age: Up to 1 Week
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All neonates who require UVC insertion as part of their intensive care during their NICU admission

You may not qualify if:

• Any neonate where the UVC is medically contra-indicated like lower limb ischemia, omphalitis, umbilical bleeding, confirmed intra-vascular thrombosis or DIC.
• Neonates with hydrops fetalis, abdominal wall defects, congenital diaphragmatic hernia, major congenital heart disease, and declined to participate or insertion of UVC beyand one week .

Sponsors & Collaborators

• King Fahad Medical City: lead

Study Sites (1)

Second Cluster ( KFMC and Alyamama Hospital )

Riyadh, 12211, Saudi Arabia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neonatology

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: March 8, 2022
• Primary Completion: August 8, 2024
• Study Completion: March 8, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)