A clinical trial to study the usefulness of ultrasound in umbilical venous catheter insertion in neonates admitted in NICU.

Active, not recruiting

• Conditions: Birth injury to central nervous system, unspecified, (2) ICD-10 Condition: P018||Newborn affected by other maternalcomplications of pregnancy, (3) ICD-10 Condition: P073||Preterm [premature] newborn [other], (4) ICD-10 Condition: P229||Respiratory distress of newborn, unspecified, (5) ICD-10 Condition: P922||Slow feeding of newborn,

• Registration Number: CTRI/2020/09/027935
• Lead Sponsor: Dr Purbasha Mishra

Brief Summary

This study is a open label randomized parallel group trial comparing ultrasound guided umbilical venous catheter insertion with conventional(blind) insertion. Trial will be conducted in preterm/term neonates who are admitted in NICU and require prolonged intravascular access. The primary outcome is to compare the failure rates of Ultrasound guided UVC insertion with the conventional method. The secondary outcomes are comparison of tip position of UVC with X-ray, to observe the complications with UVC insertion and to calculate the time difference between ultrasound and X-ray for completion of the procedure. Analysis will be done at the end of 18 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-22
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• All terms/preterm with prolonged intravascular access for the following conditions 1.
• Babies on mechanical ventilation for respiratory failure, mechanical asphyxia 2.
• Total parenteral nutrition 3.
• Shock 4.hypoglycemia with GIR>12.5% 5.IV fluids for surgical indications.

Exclusion Criteria

• 1.Congenital anomalies of abdominal wall 2.
• Necrotizing enterocolitis 3.
• Peritonitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the failure rates of usg guided umbilical venous catheter (UVC)insertion with the conventional method	Reduction in failure rate assessed after18 months

Secondary Outcome Measures

Name	Time	Method
To calculate the time taken for USG and calculate the time difference between USG and radiograph	18 months
To compare USG with X-ray in determining the tip position of UVC	18 months
To observ complications with UVC insertion	18 months

Trial Locations

Locations (1)

AIIMS Hospital; 🇮🇳 Khordha, ORISSA, India

AIIMS Hospital

🇮🇳Khordha, ORISSA, India

DrPurbasha Mishra

Principal investigator

8284825799

purbimishra25@gmail.com