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

NCT07045506 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2025-07-01

No results posted yet for this study

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

Interventions

OTHER

UVC insertion

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.

Sponsors & Collaborators

  • King Fahad Medical City

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
1 Week
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-08
Primary Completion
2024-08-08
Completion
2025-03-08

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07045506 on ClinicalTrials.gov