Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414174
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-03
Brief Title:
Comparison Between Split Septum and Mechanical Valve Needleless Connector in Preterm Babies
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None