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

University of Indonesia (UI)

Status: Completed

Conditions: Sepsis, Neonatal

Treatments: Device: Split septum needleless connector; Device: Mechanical valve needleless connector

Study type: Interventional

Funder types: Other

Identifiers

NCT06414174

NeedlelessInd

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 28 to 32 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Very preterm neonates or birth weight < 1500 gram receiving split septum needleless connector

Active Comparator group

Description:

Very preterm neonates or birth weight \< 1500 gram who needs central line access will use split septum mechanism for their needleless connector

Treatment:

Device: Split septum needleless connector

Very preterm neonates or birth weight < 1500 gram receiving mechanical valve needleless connector

Active Comparator group

Description:

Very preterm neonates or birth weight \< 1500 gram who needs central line access will use mechanical valve for their needleless connector

Treatment:

Device: Mechanical valve needleless connector