Comparison Between Split Septum and Mechanical Valve Needleless Connector in Preterm Babies

Indonesia University60 enrolled

Overview

The goal of this clinical trial study is to compare the effectiveness between split septum and mechanical valve needleless connector in very preterm babies (or under 1500 grams) The main questions it aims to answer are: * What is the incidence of Central Line-Associated Bloodstream Infections when using a split septum connector? * What is the incidence of Central Line-Associated Bloodstream Infections when using a mechanical valve connector? * What is the ratio length of stay between babies with birth weight \< 1500 grams who use split septum connector and mechanical valve? * What is the ratio incidence of mortality due to sepsis of babies with birth weight \< 1500 grams who use split septum connector and mechanical valve? Participants will be observed for two weeks after insertion of central line. They will be taken blood sample for culture and sepsis marker panel. Researchers will compare split septum group and mechanical valve group to see if there is a central line associated bloodstream infections

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Sepsis, Neonatal

Interventions

Mechanical valve needleless connectorDEVICE

Participants in this study are limited to very preterm neonates or neonates with birth weight under 1500 grams. Split septum mechanism is still widely use in Indonesia, therefore the use of mechanical valve mechanism as needleless connector for central line access in very preterm neonates have never been tested.

Eligibility

Sex: ALLMin age: 28 WeeksMax age: 32 WeeksHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Preterm neonates with gestational age less than and equal to 32 weeks * Birth weight less than 1500 gram * Neonates indicated to use central line access * Parents are willing to participate in this study and has filled and signed the informed consent letter Exclusion Criteria: * Neonates who are previously diagnosed as CLABSI * Neonates who has other focus of infection that are diagnosed before the recruitment * Suffer from congenital abnormalities

Outcomes

Primary Outcomes

Incidence of Central Line Associated Bloodstream Infection (CLABSI)

The incidence of CLABSI are proven by clinical symptoms followed by positive blood culture taken at two different site, consist of peripheral and central site

Time frame: From the date of central line insertion until the date of documented infection, whichever came first, assessed up to 30 days

Secondary Outcomes

Length of stay

The duration which the subject is hospitalized

Time frame: From the date of admission until the date of discharged or death, which ever comes first, assessed up to 100 days

CLABSI-related mortality

Incidence of death because of sepsis in CLABSI participant

Time frame: From the date of central line insertion until the date of death, assessed up to 30 days

All-cause mortality

Incidence of death in all participant

Time frame: From the date of admission until the date of death, assessed up to 100 days

Central line days

The duration of central line insertion

Time frame: From the date of central line insertion until the date of death, discharge, or maximum duration of 14 days, whichever comes first

Hospitalization cost

The total cost of hospitalization in each participant

Time frame: From the date of admission until the date of death or discharge, whichever comes first, assessed up to 100 days