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

Not Applicable

Not yet recruiting

• Conditions: Sepsis, Neonatal
• Interventions: Device: Mechanical valve needleless connector; Device: Split septum needleless connector

• Registration Number: NCT06414174
• Lead Sponsor: Indonesia University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05
• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-05-13
• Last Update Submitted: 2024-05-14
• Study First Posted: 2024-05-16
• Last Update Posted: 2024-05-16
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Very preterm neonates or birth weight < 1500 gram receiving mechanical valve needleless connector	Mechanical valve needleless connector	Very preterm neonates or birth weight \< 1500 gram who needs central line access will use mechanical valve for their needleless connector
Very preterm neonates or birth weight < 1500 gram receiving split septum needleless connector	Split septum needleless connector	Very preterm neonates or birth weight \< 1500 gram who needs central line access will use split septum mechanism for their needleless connector

Primary Outcome Measures

Name	Time	Method
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 2 weeks	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 Outcome Measures

Name	Time	Method
Length of stay	From the date of central line insertion until the date of discharged, whichever came first, assessed up to 2 weeks	The duration which the subject is hospitalized
Death	From the date of central line insertion until the date of death, whichever came first, assessed up to 2 weeks	Incidence of death because of sepsis