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

S

Singapore Health Services (SingHealth)

Status

Completed

Conditions

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

Treatments

Procedure: UVC insertion

Study type

Observational

Funder types

Other

Identifiers

NCT05022433
2019-2300

Details and patient eligibility

About

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.

Full description

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.

Enrollment

170 patients

Sex

All

Ages

Under 30 days old

Volunteers

No Healthy Volunteers

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.

Trial design

170 participants in 2 patient groups

Shukla
Description:
Shukla is a birth weight based formula to determine the insertional depth of the UVC
Treatment:
Procedure: UVC insertion
UN-1
Description:
UN-1 is a body surface based formula to determine the insertional depth of the UVC
Treatment:
Procedure: UVC insertion

Trial contacts and locations

1

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Central trial contact

MARY GRACE S TAN, MD

Data sourced from clinicaltrials.gov

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