Sepsis, Neonatal
Conditions
Brief summary
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
Interventions
DEVICESplit septum needleless connector
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.
DEVICEMechanical valve needleless connector
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.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This study involves two group of participants to receive specific intervention. One of the group will be using split septum mechanism for their needleless connector, while the other group will use mechanical valve mechanism for their needleless connector. Both group will be assessed and monitored closely for the incidence of infection
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 32 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Central Line Associated Bloodstream Infection (CLABSI) | From the date of central line insertion until the date of documented infection, whichever came first, assessed up to 30 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | From the date of admission until the date of discharged or death, which ever comes first, assessed up to 100 days | The duration which the subject is hospitalized |
| CLABSI-related mortality | From the date of central line insertion until the date of death, assessed up to 30 days | Incidence of death because of sepsis in CLABSI participant |
| All-cause mortality | From the date of admission until the date of death, assessed up to 100 days | Incidence of death in all participant |
| Central line days | From the date of central line insertion until the date of death, discharge, or maximum duration of 14 days, whichever comes first | The duration of central line insertion |
| Hospitalization cost | From the date of admission until the date of death or discharge, whichever comes first, assessed up to 100 days | The total cost of hospitalization in each participant |
Countries
Indonesia
Outcome results
None listed