Utility of Real Time Ultrasound-guided Umbilical Venous Catheterization with Liver Compression Maneuver: A Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260502011

Enrollment

Registered

2026-05-02

Start date

2026-04-28

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Real time ultrasound-guided umbilical venous catheterization with liver compression maneuver in neonates ultrasound, umbilical venous catheterization, neonates

Interventions

Participants in this arm will undergo real-time ultrasound-guided umbilical venous catheterization combined with a liver compression maneuver. The procedure will be performed under sterile conditions

Experimental Procedure/Surgery,No Intervention Procedure/Surgery

Real time ultrasound-guided umbilical venous catheterization with liver compression,Conventional formula-based umbilical venous catheterization

Eligibility

Sex/Gender

All

Age

1 Days to 7 Days

Inclusion criteria

Inclusion criteria: 1. Neonates aged 7 days or less 2. Neonates with an indication for umbilical venous catheterization, including: 2.1 Birth weight 1500 g or less 2.2 Requirement for inotropic support 2.3 Requirement for parenteral nutrition 2.4 Requirement for intravenous dextrose concentration 12% or more 2.5 Clinical indication as determined by the attending neonatologist

Exclusion criteria

Exclusion criteria: 1. Omphalitis 2. Intraabdominal infection 3. Multiple congenital anomalies 4. Congenital gastrointestinal conditions, including abdominal wall defects, umbilical hernia, omphalocele and gastroschisis 5. Parents or legal guardians refuse or do not provide consent to participate in the study

Design outcomes

Primary

Measure	Time frame
Success rate of optimal umbilical venous catheter tip placement within 0.5 cm of the junction between inferior vena cava and right atrium Within 24 hr Ultrasonography performed by blinded pediatric radiologist	—

Secondary

Measure	Time frame
Procedure duration From start to end of procedure Minutes from catheter insertion start to successful placement,Number of radiographs required to achieve optimal catheter tip position until optimal catheter tip position is achieved Total imaging attempts required until optimal catheter tip position is achieved,Incidence of hypothermia during procedure proportion of patients with body temperature less than 36.5 degrees Celsius immediately after the procedure using a standard thermometer,Incidence of hypotension during procedure Hypotension measured as proportion of patients with systolic or diastolic blood pressure below the 5th percentile,Incidence of significant desaturation during procedure Significant desaturation measured as proportion of patients requiring increased fraction of inspired oxygen to maintain target oxygen saturation,Incidence of significant apnea during procedure Significant apnea measured as proportion of patients with apnea requiring stimulation or positive pressure ventilation,Incidence of omphalitis diagnosed clinically After procedure within 7 days Omphalitis measured as proportion of patients diagnosed clinically by the attending neonatologist during hospitalization,Incidence of central line associated bloodstream infection CLABSI After procedure within 7 days CLABSI measured as proportion of patients meeting diagnostic criteria for central line associated bloodstream infection during catheter use period	—

Measure

Time frame

Procedure duration From start to end of procedure Minutes from catheter insertion start to successful placement,Number of radiographs required to achieve optimal catheter tip position until optimal catheter tip position is achieved Total imaging attempts required until optimal catheter tip position is achieved,Incidence of hypothermia during procedure proportion of patients with body temperature less than 36.5 degrees Celsius immediately after the procedure using a standard thermometer,Incidence of hypotension during procedure Hypotension measured as proportion of patients with systolic or diastolic blood pressure below the 5th percentile,Incidence of significant desaturation during procedure Significant desaturation measured as proportion of patients requiring increased fraction of inspired oxygen to maintain target oxygen saturation,Incidence of significant apnea during procedure Significant apnea measured as proportion of patients with apnea requiring stimulation or positive pressure ventilation,Incidence of omphalitis diagnosed clinically After procedure within 7 days Omphalitis measured as proportion of patients diagnosed clinically by the attending neonatologist during hospitalization,Incidence of central line associated bloodstream infection CLABSI After procedure within 7 days CLABSI measured as proportion of patients meeting diagnostic criteria for central line associated bloodstream infection during catheter use period

—

Countries

Thailand

Contacts

Public ContactSatit Manopunya

Chiang Mai University

satit.manopunya@cmu.ac.th0982391956

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026