Sepsis, NeonatalNCT06414174

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

A study testing Split septum needleless connector and Mechanical valve needleless connector in people with Sepsis, Neonatal, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 28 to 32 weeksHealthy volunteers can take part
Conditions the study is for: Sepsis, Neonatal
What is being tested?: Split septum needleless connector and Mechanical valve needleless connector
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteIndonesia
Study dates: 30 Aug 2024to 31 Jan 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 28 to 32 weeks
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10430

Other trials in Indonesia

About this study

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

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
Being tested: Split septum needleless connector, Mechanical valve needleless connector
Medical subject headings: Neonatal Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Split septum needleless connectorDevice
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.
Mechanical valve needleless connectorDevice
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.

Study groups in NCT06414174
Study group	Role	What they receive
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 Receives: 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 Receives: Device: Mechanical valve needleless connector

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
The duration which the subject is hospitalized
Measured: From the date of admission until the date of discharged or death, which ever comes first, assessed up to 100 days
CLABSI-related mortality
Incidence of death because of sepsis in CLABSI participant
Measured: 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
Measured: From the date of admission until the date of death, assessed up to 100 days
Central line days
The duration of central line insertion
Measured: 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
Measured: From the date of admission until the date of death or discharge, whichever comes first, assessed up to 100 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 202431 Jan 2025

First posted16 May 2024
Study start30 Aug 2024
Primary completion14 Jan 2025
Study completion31 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Sepsis, NeonatalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06414174
Sponsor's protocol ID: NeedlelessInd
Status last verified: Nov 2025
First submitted: 3 May 2024
Last updated: 24 Nov 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The data will not be shared because of the confidentiality agreement stated in the informed consent form

Publications

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.
PubMed 35241185
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.
PubMed 38103692
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.
PubMed 40082115
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.
PubMed 17464926
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.
PubMed 24915204
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.
PubMed 37088696
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.
PubMed 19911973
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.
PubMed 31393341
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.
PubMed 23252685
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.
PubMed 28875883
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.
PubMed 35485786
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.
PubMed 30853200

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
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G-CSF In Neonatal Sepsis With Neutropenia
Neonatal Sepsis, Neutropenia
RecruitingObservational study
Impact of a Multi-infusion Strategy in Neonatology on the Rate of Central Line-associated Bloodstream Infections
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All Sepsis, Neonatal trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06414174
Acronym / sponsor ID: NeedlelessInd
Conditions: Sepsis, Neonatal
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Universitas IndonesiaUniversity, hospital or other
Study start: 30 Aug 2024 (actual)
Primary completion: 14 Jan 2025 (actual)
Study completion: 31 Jan 2025 (actual)
First posted: 16 May 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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

Arm	Type	Receives
Very preterm neonates or birth weight < 1500 gram receiving split septum needleless connector	Active comparator	Device: Split septum needleless connectorVery 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	Device: Mechanical valve needleless connectorVery preterm neonates or birth weight < 1500 gram who needs central line access will use mechanical valve for their needleless connector

Who may qualify

Ages: 28 to 32 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Split septum needleless connectorParticipants 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.	Device	Very preterm neonates or birth weight < 1500 gram receiving split septum needleless connector
Mechanical valve needleless connectorParticipants 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.	Device	Very preterm neonates or birth weight < 1500 gram receiving mechanical valve needleless connector

Primary outcome

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 30 days
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

5 secondary outcomes

Length of stay
Time frame: From the date of admission until the date of discharged or death, which ever comes first, assessed up to 100 days
CLABSI-related mortality
Time frame: From the date of central line insertion until the date of death, assessed up to 30 days
All-cause mortality
Time frame: From the date of admission until the date of death, assessed up to 100 days
Central line days
Time frame: From the date of central line insertion until the date of death, discharge, or maximum duration of 14 days, whichever comes first
Hospitalization cost
Time frame: From the date of admission until the date of death or discharge, whichever comes first, assessed up to 100 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
Background: PubMed 35241185Muller 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.
Background: PubMed 38103692Jansen 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.
Background: PubMed 40082115Urrea 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.
Background: PubMed 17464926Field 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.
Background: PubMed 24915204Marschall 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.
Background: PubMed 37088696Ryder 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.
Background: PubMed 19911973Jarvis 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.
Background: PubMed 31393341Li 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.
Background: PubMed 23252685Westergaard 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.
Background: PubMed 28875883Geldenhuys 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.
Background: PubMed 35485786Nielsen 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.
Background: PubMed 30853200Zipursky 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.
Individual participant dataSharing planned: No. The data will not be shared because of the confidentiality agreement stated in the informed consent form

Related trials for Sepsis, Neonatal

RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Split septum needleless connector and Mechanical valve needleless connector in people with Sepsis, Neonatal, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06414174, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.