Antimicrobial Impregnated Umbilical Catheters for reduction of Catheter Related Blood Stream infections in neonates

Comparison of reduction of catheter related blood stream infection in neonate by using impregnated antimicrobial system umbilical venous catheter with standard umbilical venous catheter. - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/073104

Enrollment

Registered

2024-08-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Health Condition 1: P369- Bacterial sepsis of newborn, unspecified

Interventions

Intervention1: Silver-impregnated double-lumen umbilical venous catheterisation: Umbilical venous catheterisation will be done soon after admission to NICU.The catheter will be kept insitu for maximum

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants less or equal to 32 weeks GA needing umbilical venous catheterisation. Indication for umbilical venous catheterisation would be all preterm infants less than 28 weeks or 1000 grams, need for inotropes, Difficult vascular access or infant needing more than 10% dextrose concentration

Exclusion criteria

Exclusion criteria: neonate with congenital abdominal wall defects such as gastroschisis and omphalocele.

Design outcomes

Primary

Measure	Time frame
Rate of catheter-related bloodstream infectionsTimepoint: duration of NICU stay	—

Secondary

Measure	Time frame
Signs of local infection . Side effects of silver . Bluish discoloration of the skin (argyria) . Increase in transaminase levels (SGOT/SGPT) . All grade Intraventricular bleed . Incidence of ROP . Necrotizing enterocolitisTimepoint: During NICU stay	—

Countries

India

Contacts

Public ContactDr Sachin Shah

Surya Mother and child superspeciality hospital

priya1012ankita@gmail.com8619530281

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026