CompletedNot Applicable

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

Saudi Arabia184 participantsStarted 2022-03-08

Plain-language 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.

Who can participate

Age range

1 Week

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All neonates who require UVC insertion as part of their intensive care during their NICU admission Exclusion Criteria: * 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 .

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Within 48 Hours

Trial details

NCT IDNCT07045506

SponsorKing Fahad Medical City

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-08-08

View on ClinicalTrials.gov More Estimating Umbilical Venous Catheter Insertion Depth in Newborns Using Weight or Body Measurements trials