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

May 14, 2024 updated by: Dr. dr. Putri Maharani Tristanita Marsubrin, Sp. A(K), Indonesia University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Very preterm neonates or birth weight < 1500 gram receiving 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
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.
Active Comparator: Very preterm neonates or birth weight < 1500 gram receiving 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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
From the date of central line insertion until the date of documented infection, whichever came first, assessed up to 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: 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
From the date of central line insertion until the date of discharged, whichever came first, assessed up to 2 weeks
Death
Time Frame: 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
From the date of central line insertion until the date of death, whichever came first, assessed up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NeedlelessInd

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will not be shared because of the confidentiality agreement stated in the informed consent form

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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