NCT06414174

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 28 Weeks – 32 Weeks
• Healthy volunteers: Accepted

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

Conditions

• Sepsis, Neonatal

Interventions

Type	Name	Description
DEVICE	Split 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.
DEVICE	Mechanical 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.

Timeline

• Start date: 2024-08-30
• Primary completion: 2025-01-14
• Completion: 2025-01-31
• First posted: 2024-05-16
• Last updated: 2025-11-24

Locations

1 site across 1 country: Indonesia