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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | The duration which the subject is hospitalized | From the date of admission until the date of discharged or death, which ever comes first, assessed up to 100 days |
| CLABSI-related mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo Hospital | Jakarta Pusat | Jakarta Special Capital Region | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35241185 | Background | 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. | |
| 38103692 |
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The data will not be shared because of the confidentiality agreement stated in the informed consent form
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| ID | Term |
|---|---|
| D000071074 | Neonatal Sepsis |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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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
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|
| 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. |
|
Incidence of death because of sepsis in CLABSI participant
| From the date of central line insertion until the date of death, assessed up to 30 days |
| All-cause mortality | Incidence of death in all participant | From the date of admission until the date of death, assessed up to 100 days |
| Central line days | The duration of central line insertion | From the date of central line insertion until the date of death, discharge, or maximum duration of 14 days, whichever comes first |
| Hospitalization cost | The total cost of hospitalization in each participant | From the date of admission until the date of death or discharge, whichever comes first, assessed up to 100 days |
| 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. |
| 40082115 | 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. |
| 17464926 | 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. |
| 24915204 | 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. |
| 37088696 | 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. |
| 19911973 | 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. |
| 31393341 | 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. |
| 23252685 | 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. |
| 28875883 | 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. |
| 35485786 | 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. |
| 30853200 | 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. |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |