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

NCT06414174 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-11-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-30
Primary Completion
2025-01-14
Completion
2025-01-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06414174 on ClinicalTrials.gov