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

NCT06414174 | Completed DMC

• 1 other identifier: NeedlelessInd
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Sepsis, Neonatal

Outcome Measures

Primary Outcomes (1)

• Incidence of Central Line Associated Bloodstream Infection (CLABSI)

  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 30 days

Secondary Outcomes (5)

• Length of stay

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

• CLABSI-related mortality

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

• All-cause mortality

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

• Central line days

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

• Hospitalization cost

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

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

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

Interventions

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.

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

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.

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

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Neonates who are previously diagnosed as CLABSI
• Neonates who has other focus of infection that are diagnosed before the recruitment
• Suffer from congenital abnormalities

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Related Publications (12)

• Muller M, Bryant KA, Espinosa C, Jones JA, Quach C, Rindels JR, Stewart DL, Zangwill KM, Sanchez PJ. SHEA Neonatal Intensive Care Unit (NICU) White Paper Series: Practical approaches for the prevention of central-line-associated bloodstream infections. Infect Control Hosp Epidemiol. 2023 Apr;44(4):550-564. doi: 10.1017/ice.2022.53. Epub 2022 Mar 4.

  PMID: 35241185 BACKGROUND

• Jansen SJ, Broer SDL, Hemels MAC, Visser DH, Antonius TAJ, Heijting IE, Bergman KA, Termote JUM, Hutten MC, van der Sluijs JPF, d'Haens EJ, Kornelisse RF, Lopriore E, Bekker V. Central-line-associated bloodstream infection burden among Dutch neonatal intensive care units. J Hosp Infect. 2024 Feb;144:20-27. doi: 10.1016/j.jhin.2023.11.020. Epub 2023 Dec 14.

  PMID: 38103692 BACKGROUND

• Urrea Ayala M, Almendral A, Jordan Garcia I, Reyne Vergeli M, Porron R, Llado Maura Y, Limon E, Pujol M; VINCat Pediatric and Neonatal ICU Bacteremia Programme. Central line-associated bloodstream infections (CLABSI) in pediatric and neonatal intensive care units-The VINCat program 2013-2022. Enferm Infecc Microbiol Clin (Engl Ed). 2025 May;43 Suppl 1:S90-S97. doi: 10.1016/j.eimce.2024.09.014. Epub 2025 Mar 12.

  PMID: 40082115 BACKGROUND

• Field K, McFarlane C, Cheng AC, Hughes AJ, Jacobs E, Styles K, Low J, Stow P, Campbell P, Athan E. Incidence of catheter-related bloodstream infection among patients with a needleless, mechanical valve-based intravenous connector in an Australian hematology-oncology unit. Infect Control Hosp Epidemiol. 2007 May;28(5):610-3. doi: 10.1086/516660. Epub 2007 Apr 12.

  PMID: 17464926 BACKGROUND

• Marschall J, Mermel LA, Fakih M, Hadaway L, Kallen A, O'Grady NP, Pettis AM, Rupp ME, Sandora T, Maragakis LL, Yokoe DS; Society for Healthcare Epidemiology of America. Strategies to prevent central line-associated bloodstream infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 Jul;35(7):753-71. doi: 10.1086/676533. No abstract available.

  PMID: 24915204 BACKGROUND

• Ryder M, deLancey-Pulcini E, Parker AE, James GA. Bacterial transfer and biofilm formation in needleless connectors in a clinically simulated in vitro catheter model. Infect Control Hosp Epidemiol. 2023 Nov;44(11):1760-1768. doi: 10.1017/ice.2023.60. Epub 2023 Apr 24.

  PMID: 37088696 BACKGROUND

• Jarvis WR, Murphy C, Hall KK, Fogle PJ, Karchmer TB, Harrington G, Salgado C, Giannetta ET, Cameron C, Sherertz RJ. Health care-associated bloodstream infections associated with negative- or positive-pressure or displacement mechanical valve needleless connectors. Clin Infect Dis. 2009 Dec 15;49(12):1821-7. doi: 10.1086/648418.

  PMID: 19911973 BACKGROUND

• Li R, Cao X, Shi T, Xiong L. Application of peripherally inserted central catheters in critically ill newborns experience from a neonatal intensive care unit. Medicine (Baltimore). 2019 Aug;98(32):e15837. doi: 10.1097/MD.0000000000015837.

  PMID: 31393341 BACKGROUND

• Westergaard B, Classen V, Walther-Larsen S. Peripherally inserted central catheters in infants and children - indications, techniques, complications and clinical recommendations. Acta Anaesthesiol Scand. 2013 Mar;57(3):278-87. doi: 10.1111/aas.12024. Epub 2012 Dec 17.

  PMID: 23252685 BACKGROUND

• Geldenhuys C, Dramowski A, Jenkins A, Bekker A. Central-line-associated bloodstream infections in a resource-limited South African neonatal intensive care unit. S Afr Med J. 2017 Aug 25;107(9):758-762. doi: 10.7196/SAMJ.2017.v107i9.12124.

  PMID: 28875883 BACKGROUND

• Nielsen CL, Zachariassen G, Holm KG. Central line-associated bloodstream infection in infants admitted to a level lllneonatal intensive care unit. Dan Med J. 2022 Apr 7;69(5):A05210463.

  PMID: 35485786 BACKGROUND

• Zipursky AR, Yoon EW, Emberley J, Bertelle V, Kanungo J, Lee SK, Shah PS; Canadian Neonatal Network Investigators. Central Line-Associated Blood Stream Infections and Non-Central Line-Associated Blood Stream Infections Surveillance in Canadian Tertiary Care Neonatal Intensive Care Units. J Pediatr. 2019 May;208:176-182.e6. doi: 10.1016/j.jpeds.2018.12.011. Epub 2019 Mar 8.

  PMID: 30853200 BACKGROUND

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Model Details: 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

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 16, 2024
• Study Start: August 30, 2024
• Primary Completion: January 14, 2025
• Study Completion: January 31, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)