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Completed

NCT Number: NCT06414174

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

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

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Key information

Conditions

Sepsis, Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infections Inflammation Neonatal Sepsis Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

28 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Split septum needleless connector

Device

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.

Mechanical valve needleless connector

Device

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.

Primary outcomes

  1. Incidence of Central Line Associated Bloodstream Infection (CLABSI)

    Time frame: From the date of central line insertion until the date of documented infection, whichever came first, assessed up to 30 days

    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 outcomes

  1. Length of stay

    Time frame: From the date of admission until the date of discharged or death, which ever comes first, assessed up to 100 days

    The duration which the subject is hospitalized

  2. CLABSI-related mortality

    Time frame: From the date of central line insertion until the date of death, assessed up to 30 days

    Incidence of death because of sepsis in CLABSI participant

  3. All-cause mortality

    Time frame: From the date of admission until the date of death, assessed up to 100 days

    Incidence of death in all participant

  4. Central line days

    Time frame: From the date of central line insertion until the date of death, discharge, or maximum duration of 14 days, whichever comes first

    The duration of central line insertion

  5. Hospitalization cost

    Time frame: From the date of admission until the date of death or discharge, whichever comes first, assessed up to 100 days

    The total cost of hospitalization in each participant

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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