Clinical trial NCT05022433: Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates
Official title: Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates: A Randomized Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extreme Prematurity,Extremely Low Birthweight
Extremely Low Birth Weight
Very Low Birth Weight Infant
Neonatal Hypoglycemia
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 170
Sex: ALL
Minimum age (years): 0
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All term and preterm newborns admitted in Singapore General Hospital requiring UVC insertion with no major congenital malformation will be included in the study.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of the Shukla and UN-1 formulae in the Placement of the UVC Among Neonates:A Randomized Clinical Study
timeFrame: 14 days
Secondary outcomes:
measure: Comparison of the Shukla and UN-1 formulae in the Placement of the UVC Among Neonates:A Randomized Clinical Study
timeFrame: 14 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: MARY GRACE S TAN, MD
role: PRINCIPAL_INVESTIGATOR
References: