Clinical trial NCT06414174: Comparison Between Split Septum and Mechanical Valve Needleless Connector in Preterm Babies
Official title: Comparison Between Split Septum and Mechanical Valve Needleless Connector in Preventing Central Line-Associated Bloodstream Infections in Very Preterm Babies or Birth Weight <1500 Grams at Cipto Mangunkusumo Hospital Neonatology Unit
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sepsis, Neonatal
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 28
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Central Line Associated Bloodstream Infection (CLABSI)
timeFrame: From the date of central line insertion until the date of documented infection, whichever came first, assessed up to 2 weeks
Secondary outcomes:
measure: Length of stay
timeFrame: From the date of central line insertion until the date of discharged, whichever came first, assessed up to 2 weeks
measure: Death
timeFrame: From the date of central line insertion until the date of death, whichever came first, assessed up to 2 weeks
Other outcomes:
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