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NCT Number: NCT05022433

Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates

Umbilical vein catheters (UVC) are commonly inserted in newborns especially neonates admitted to the Neonatal Intensive Care Unit (NICU).These catheters are used since 1959. It is a suitable method for parenteral nutrition access and medications administration. Despite the benefits of the UVC, its potential complications must be considered. Thus, it is vital to determine the appropriate penetration length of the UVC.

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Key information

Conditions

Extreme Prematurity,Extremely Low Birthweight Extremely Low Birth Weight Neonatal Hypoglycemia Very Low Birth Weight Infant

Age range

0 day–30 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Singapore General Hospital

Singapore, 169608

About this study

UVC insertion has benefits and potential complications such as infection, intestinal necrosis, thrombosis, ascites, hydrothorax, cardiac tamponade, cardiac arrhythmias, pleural effusion, pericarditis and pericardial effusion. The complications may be due to insertion of catheter in an inappropriate location. Imaging procedures such as plain thoracoabdominal x-ray is needed after catheter insertion to specify the location of the catheter tip. In addition to preventing complications, insertion of umbilical venous catheter in an appropriate location is essential for umbilical catheterisation effectiveness. There are different methods to determine the length of catheter which must be inserted in umbilical vessels. The UVC formulae are based on either body surface measurement such as Dunn method, Umbilical to Intermammary Distance (UIMD), Umbilical to Nipple Distance (UN)-1 and birthweight based formula method such as Shukla and Modified Shukla. Shukla and UN-1 Methods have been widely used in the world. However, the accuracy of these two methods in estimating the length of umbilical venous catheter has not still demonstrated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All term and preterm newborns requiring UVC insertion will be included in the study.

Exclusion criteria

  • All neonates with major congenital malformations that interferes with the placement of the UVC will be excluded.

Treatment and study plan

UVC insertion

Procedure

To compare two formulae namely UN-1 and Shukla method to estimate the UVC insertion length in achieving optimum UVC tip position.

Primary outcomes

  1. Comparison of the Shukla and UN-1 formulae in the Placement of the UVC Among Neonates:A Randomized Clinical Study

    Time frame: 14 days

    Using the chest and abdominal X-ray, the distance of the UVC tip position in reference to the diaphragm level is measured.UVC tip position is then labeled as either IDEAL,SHORT or DEEP position. Ideal position is defined as the UVC tip is at the diaphragm level or +/- 0.5cm distance from the diaphragm. Short UVC is defined if the UVC tip is >0.5 cm below the diaphragm.Deep UVC position is defined as if the UVC tip is > 0.5cm above the diaphragm.

Secondary outcomes

  1. Comparison of the Shukla and UN-1 formulae in the Placement of the UVC Among Neonates:A Randomized Clinical Study

    Time frame: 14 days

    Using the chest and abdominal X-ray, the distance of the UVC tip position in reference between the upper border of T9 to the lower border of T10 level is measured. UVC tip position is then labeled as IDEAL, SHORT and DEEP UVC position.Ideal position is defined as the UVC tip position in between the level of the upper border of T9 to the lower border of T10. Short UVC if the tip is below the lower border of T10. Deep UVC position is defined as the UVC tip above the upper border of T9.

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Registry information

Official study title

Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates: A Randomized Clinical Study

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 26, 2021
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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