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

NCT05022433 | Completed

• 1 other identifier: 2019-2300
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  14 days

Secondary Outcomes (1)

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

  14 days

Study Arms (2)

Shukla

Shukla is a birth weight based formula to determine the insertional depth of the UVC

Procedure: UVC insertion

UN-1

UN-1 is a body surface based formula to determine the insertional depth of the UVC

Procedure: UVC insertion

Interventions

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.

Shukla; UN-1

Eligibility Criteria

• Age: 0 Days - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Study Officials

• MARY GRACE S TAN, MD

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 26, 2021
• Study Start: June 6, 2019
• Primary Completion: October 11, 2023
• Study Completion: October 11, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

SG (1)