Very Low Birth Weight Infant Clinical Trial
Official title:
Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates: A Randomized Clinical Study
NCT number | NCT05022433 |
Other study ID # | 2019-2300 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 6, 2019 |
Est. completion date | October 11, 2023 |
Verified date | December 2023 |
Source | Singapore General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 170 |
Est. completion date | October 11, 2023 |
Est. primary completion date | October 11, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Days to 30 Days |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Singapore | Singapore General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore General Hospital |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 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. | 14 days |
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