## Protocol Section
### Identification Module
**NCT ID:** NCT06414174

**Brief Title:** Comparison Between Split Septum and Mechanical Valve Needleless Connector in Preterm Babies

**Official 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

#### Organization Study ID Info
**ID:** NeedlelessInd
#### Organization
**Class:** OTHER
**Full Name:** Indonesia University
### Status Module
#### Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Indonesia University

#### Responsible Party

**Investigator Affiliation:** Indonesia University

**Investigator Full Name:** Dr. dr. Putri Maharani Tristanita Marsubrin, Sp. A(K)

**Investigator Title:** Neonatologist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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 Module

**Conditions:**

- Sepsis, Neonatal

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** This study involves two group of participants to receive specific intervention. One of the group will be using split septum mechanism for their needleless connector, while the other group will use mechanical valve mechanism for their needleless connector. Both group will be assessed and monitored closely for the incidence of infection

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: Split septum needleless connector

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

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Device: Mechanical valve needleless connector

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

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

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

**Description:** 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.

**Name:** Split septum needleless connector

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

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

**Description:** 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.

**Name:** Mechanical valve needleless connector

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** 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

#### Secondary Outcomes

**Description:** The duration which the subject is hospitalized

**Measure:** 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

**Description:** Incidence of death because of sepsis

**Measure:** Death

**Time Frame:** From the date of central line insertion until the date of death, whichever came first, assessed up to 2 weeks

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 32 Weeks

**Minimum Age:** 28 Weeks

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** putristanita2806@yahoo.com

**Name:** Putri Maharani Tristanita Marsubrin, Doctoral

**Phone:** +62 8128126640

**Role:** CONTACT

### IPD Sharing Statement Module

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

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000018805

- Term: Sepsis

- ID: D000007239

- Term: Infections

- ID: D000007232

- Term: Infant, Newborn, Diseases

- ID: D000018746

- Term: Systemic Inflammatory Response Syndrome

- ID: D000007249

- Term: Inflammation

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M25869

- Name: Premature Birth

- Relevance: LOW

- As Found: Unknown

- ID: M5006

- Name: Birth Weight

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M20864

- Name: Sepsis

- Relevance: LOW

- As Found: Unknown

- ID: M16869

- Name: Toxemia

- Relevance: LOW

- As Found: Unknown

- ID: M696

- Name: Neonatal Sepsis

- Relevance: HIGH

- As Found: Sepsis, Neonatal

- ID: M10276

- Name: Infant, Newborn, Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M20818

- Name: Systemic Inflammatory Response Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000071074

- Term: Neonatal Sepsis

### Misc Info Module

- Version Holder: 2024-05-31
