Early-Onset Neonatal SepsisPRESAFENCT06100614
Presepsin to Safely Reduce Antibiotics in Preterm Infants
A study testing Presepsin in people with Early-Onset Neonatal Sepsis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
In the Netherlands, more than 85% of the preterm infants born <32 weeks gestational age get antibiotics directly after birth because of the risk of infection with a bacteria. However, only 1 in 70 of these preterm babies actually has a bacterial infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Early-Onset Neonatal Sepsis
- What is being tested?
- Presepsin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Sep 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infants born at a gestational age of 24+0 to 31 6/7 weeks
- Moderate risk of early-onset neonatal sepsis, i.e. infants who should be treated with empirical antibiotics based on the Dutch EOS guideline.
Who cannot join
- low risk of early-onset neonatal sepsis who do not have an indication for empirical antibiotics according to the Dutch EOS guideline;
- high risk of early-onset neonatal sepsis defined as:
- suspected or confirmed diagnosis of maternal sepsis;
- suspected or proven EOS in other infants (in case of multiple births) or infants born to mothers with previous infant with GBS disease/infection;
- unexplained respiratory insufficiency requiring invasive mechanical ventilation and FiO2>0.40 or non-invasive ventilation with FiO2 >0.60 at time of randomization;
- ongoing hemodynamic instability requiring inotrope medication or more than one 10 ml/kg fluid bolus at time of randomization;
- strong clinical concern for sepsis due to physical exam findings (i.e. minimal responsiveness, poor tone).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1105 AZ
Douwe Visser, MD PhD, 0031205669111, d.h.visser@amsterdamumc.nl
Charlotte Nusman, MD PhD, 0031205669111, c.m.nusman@amsterdamumc.nl
About this study
Official title: Presepsin to Safely Reduce Antibiotics in Preterm Infants: a Randomized Controlled Trial
In the Netherlands, more than 85% of the preterm infants born <32 weeks gestational age get antibiotics directly after birth because of the risk of infection with a bacteria. However, only 1 in 70 of these preterm babies actually has a bacterial infection. The use of antibiotics after birth can lead to problems on short term (bowel infection, infection with a bacteria later on or death) or long term (asthma, allergy, obesity).
The goal of the PRESAFE trial is to investigate whether addition of a biomarker (presepsin) to the Dutch early-onset neonatal sepsis (EOS) guideline safely reduces unnecessary empirical antibiotic exposure after birth in preterm infants born before 32 weeks gestational age. In this 874-subject multicenter, randomized clinical trial with a concurrent observational cohort, the hypothesis to be tested is that by adding presepsin to the national guideline the amount of unnecessary empirical antibiotic exposure after birth will be reduced with at least 30% without increase in infants with untreated sepsis. The study targets a population of clinical stable very preterm infants with risk factors for eary-onset neonatal sepsis. Antibiotic administration after birth is started to pre-emptively treat EOS.
By adding a presepsin-guided step to the Dutch EOS guideline for those infants qualifying for antibiotic treatment, it is assumed that the rate of antibiotic administration can be reduced. However, it is imperative that this reduction in antibiotics is not outweighed by an increase in (culture proven) EOS. Therefore, the co-primary outcomes of the study are: 1) the incidence of culture-proven EOS (non-inferiority) and 2) unnecessary antibiotics prescription i.e. antibiotic administration for ≤ 3 days when started within the first 72 hours after birth (superiority). Secondary outcomes include sepsis-related severity of illness, total number of antibiotic days when started < 72 hours after birth, and the composite outcome of necrotizing enterocolitis (NEC), late-onset sepsis (LOS), or death until discharge from the initial hospital.
Read the detailed description
STUDY POPULATION
All infants born at a gestational age of 24+0 to 31 6/7 weeks are eligible for enrollment. As part of standard care all infants will be screened and classified according to the Dutch EOS guideline for the indication of starting empirical antibiotics:
- Infants at low risk of EOS who do not have an indication for empirical antibiotics according to the Dutch EOS guideline; ii. Infants at high risk of EOS defined as: 1) suspected or confirmed diagnosis of maternal sepsis; 2) suspected or proven EOS in other infants (in case of multiple births) or infants born to mothers with previous infant with GBS disease/infection; 3) unexplained respiratory insufficiency requiring invasive mechanical ventilation and FiO2>0.40 or non-invasive ventilation with FiO2 >0.60 at time of randomization; 4) ongoing hemodynamic instability requiring inotrope medication or more than one 10 ml/kg fluid bolus at time of randomization; 5) strong clinical concern for sepsis due to physical exam findings (i.e. minimal responsiveness, poor tone). iii. Infants at moderate risk of EOS who should be treated with empirical antibiotics based on the Dutch EOS guideline. In this group of infants the risks and benefits of receiving empiric antibiotics remain unclear and clinical equipoise is suggested.
Infants in category i. and ii. will be excluded for randomization and included in the observational part of the study; these patients will be further treated according to the Dutch EOS guideline. Infants in category iii. are eligible to be included in the RCT-part of the study.
RANDOMIZATION
Included category iii infants will be evaluated for EOS with blood culture and randomly assigned (1:1) to one of the following study groups:
Intervention-group, presepsin-guided therapy: The decision to start empirical antibiotics in this group will be based on presepsin measurement within four hours after birth. When the presepsin value is above the cut-off value of 645 pg/ml, antibiotics will be ordered and administered within 4 hours of life and discontinued following the criteria of the Dutch EOS guideline. Cessation of antibiotic treatment typically occurs when blood culture results remain sterile within 3 days after birth.
When the presepsin level is below the cut-off value of 645 pg/ml, the treating physician will not start antibiotic treatment. These infants will be closely observed for at least 72 hours. In case of deterioration of the clinical condition within this observation period, the clinician can decide to perform a sepsis evaluation and start with antibiotic treatment. Investigators anticipate that <5% of infant subjects will experience worsening of conditions. When the initial blood culture in this group turns back positive without clinical signs and symptoms of EOS sepsis, a new blood culture and antibiotic treatment will be advised.
Comparator-group, standard care: Standard care according to the Dutch EOS guideline. Presepsin will be determined with the treating physician blinded for the test result. In the Dutch EOS guideline maternal and neonatal risk factors for EOS are categorized as red flags or minor criteria. In the presence of 1 red flag or ≥ 2 minor criteria it is advised to perform a blood culture (= sepsis evaluation) and start empirical antibiotics for EOS suspicion.2 Antibiotic treatment will be advised to discontinue when blood culture turns back negative, reassuring the infants clinical condition with no other indicators of possible infection (e.g. CRP).
Randomization will be performed centrally, using web-based block randomization stratified by study site with random permuted blocks within the strata. Randomization sequence is generated using Castor EDC, which is regulatory compliant software, ensuring allocation concealment. Multiples (i.e. siblings) will be randomized to the same treatment arm.
- Conditions
- Early-Onset Neonatal Sepsis
- Being tested
- Presepsin, Standard Care
- Keywords
- preterm infants, antibiotics, presepsin
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PresepsinDiagnostic test
Umbilical cord blood or blood from the first routine venous puncture within four hours after birth will be used for presepsin determination. Presepsin measurement can be performed in 100 μl plasma with "PATHFAST™ Presepsin" which is a rapid chemiluminescent enzyme immunoassay (Mitsubishi Chemical Medience corporation, Tokyo, Japan) with results available within 15 minutes.
Standard CareDiagnostic test
Standard care according to the Dutch EOS guideline
| Study group | Role | What they receive |
|---|---|---|
| Presepsin-guided therapy | Experimental | The decision to start empirical antibiotics in this group will be based on presepsin measurement within four hours after birth. When the presepsin value is above the cut-off value of 645 pg/ml, antibiotics will be ordered and administered within 4 hours of life and discontinued following the criteria of the Dutch EOS guideline. When the presepsin level is below the cut-off value of 645 pg/ml, the treating physician will not start antibiotic treatment. These infants will be closely observed for at least 72 hours. In case of deterioration of the clinical condition within this observation period, the clinician can decide to perform a sepsis evaluation and start with antibiotic treatment. Receives: Diagnostic Test: Presepsin |
| Standard care | Active comparator | Standard care according to the Dutch EOS guideline. Presepsin will be determined with the treating physician blinded for the test result. In the Dutch EOS guideline maternal and neonatal risk factors for EOS are categorized as red flags or minor criteria. In the presence of 1 red flag or ≥ 2 minor criteria it is advised to perform a blood culture (= sepsis evaluation) and start empirical antibiotics for EOS suspicion. Antibiotic treatment will be advised to discontinue when blood culture turns back negative, reassuring the infants clinical condition with no other indicators of possible infection (e.g. CRP). Receives: Diagnostic Test: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of culture-proven early-onset sepsis
non-inferiority
Measured: 72 hours after birth
presence of unnecessary antibiotics prescription
antibiotic administration for ≤3 days when started within the first 72 hours after birth (superiority)
Measured: 72 hours after birth
Secondary outcomes (5)
sepsis-associated severity of illness (nSOFA)
Sepsis-associated severity of illness will be evaluated with the nSOFA score (a combination of respiratory, cardiovascular and hematologic dysfunction)
Measured: from birth until discharge from initial hospital (up to 6 months)
sepsis-associated severity of illness (meningitis)
Sepsis-associated severity of illness will be evaluated with the incidence of meningitis within seven days after disease onset.
Measured: from birth until discharge from initial hospital (up to 6 months)
sepsis-associated severity of illness (death)
Sepsis-associated severity of illness will be evaluated with the incidence of death within seven days after disease onset.
Measured: from birth until discharge from initial hospital (up to 6 months)
total number of antibiotic days when started < 72 hours after birth
Measured: from birth until discharge from initial hospital (up to 6 months)
Presence of necrotizing enterocolitis and/or late-onset sepsis and/or death
NEC is defined by Bell's stages II or III. LOS is defined as a positive blood culture obtained after 72 hours of life and intent to treat with antibiotics for 5 days or more. Death is defined as death during the index hospitalization.
Measured: from birth until discharge from initial hospital (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start23 Sep 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early-Onset Neonatal SepsisStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douwe Visser, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Douwe Visser, MD PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100614
- Sponsor's protocol ID
- 10140022210043
- Acronym
- PRESAFE
- Status last verified
- Sep 2025
- First submitted
- 15 Oct 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Nusman CM, Taal HR, Vijlbrief DC, Bekker V, van Mechelen KWG, de Boode WP, Hemels MAC, Flores CML, Roescher AM, Nuytemans DHGM, Obermann-Borst SA, van der Flier M, van Bodegom-Vos L, Ramakers CRB, Schotman HHM, de Borgie CAJM, Merkus MP, Leeflang MMG, van Kaam AH, Onland W, Visser DH. Presepsin to safely reduce antibiotics in preterm infants (PRESAFE): study protocol for a randomized controlled trial with a concurrent observational study. Trials. 2026 Feb 27;27(1):267. doi: 10.1186/s13063-026-09515-8.
PubMed 41749329
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presepsin to Safely Reduce Antibiotics in Preterm Infants: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06100614
- Acronym / sponsor ID
- PRESAFE / 10140022210043
- Conditions
- Early-Onset Neonatal Sepsis
- Keywords
- preterm infants, antibiotics, presepsin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 25 Oct 2023 (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.
In the Netherlands, more than 85% of the preterm infants born <32 weeks gestational age get antibiotics directly after birth because of the risk of infection with a bacteria. However, only 1 in 70 of these preterm babies actually has a bacterial infection. The use of antibiotics after birth can lead to problems on short term (bowel infection, infection with a bacteria later on or death) or long term (asthma, allergy, obesity).
The goal of the PRESAFE trial is to investigate whether addition of a biomarker (presepsin) to the Dutch early-onset neonatal sepsis (EOS) guideline safely reduces unnecessary empirical antibiotic exposure after birth in preterm infants born before 32 weeks gestational age. In this 874-subject multicenter, randomized clinical trial with a concurrent observational cohort, the hypothesis to be tested is that by adding presepsin to the national guideline the amount of unnecessary empirical antibiotic exposure after birth will be reduced with at least 30% without increase in infants with untreated sepsis. The study targets a population of clinical stable very preterm infants with risk factors for eary-onset neonatal sepsis. Antibiotic administration after birth is started to pre-emptively treat EOS.
By adding a presepsin-guided step to the Dutch EOS guideline for those infants qualifying for antibiotic treatment, it is assumed that the rate of antibiotic administration can be reduced. However, it is imperative that this reduction in antibiotics is not outweighed by an increase in (culture proven) EOS. Therefore, the co-primary outcomes of the study are: 1) the incidence of culture-proven EOS (non-inferiority) and 2) unnecessary antibiotics prescription i.e. antibiotic administration for ≤ 3 days when started within the first 72 hours after birth (superiority). Secondary outcomes include sepsis-related severity of illness, total number of antibiotic days when started < 72 hours after birth, and the composite outcome of necrotizing enterocolitis (NEC), late-onset sepsis (LOS), or death until discharge from the initial hospital.
Detailed description
STUDY POPULATION
All infants born at a gestational age of 24+0 to 31 6/7 weeks are eligible for enrollment. As part of standard care all infants will be screened and classified according to the Dutch EOS guideline for the indication of starting empirical antibiotics:
- Infants at low risk of EOS who do not have an indication for empirical antibiotics according to the Dutch EOS guideline; ii. Infants at high risk of EOS defined as: 1) suspected or confirmed diagnosis of maternal sepsis; 2) suspected or proven EOS in other infants (in case of multiple births) or infants born to mothers with previous infant with GBS disease/infection; 3) unexplained respiratory insufficiency requiring invasive mechanical ventilation and FiO2>0.40 or non-invasive ventilation with FiO2 >0.60 at time of randomization; 4) ongoing hemodynamic instability requiring inotrope medication or more than one 10 ml/kg fluid bolus at time of randomization; 5) strong clinical concern for sepsis due to physical exam findings (i.e. minimal responsiveness, poor tone). iii. Infants at moderate risk of EOS who should be treated with empirical antibiotics based on the Dutch EOS guideline. In this group of infants the risks and benefits of receiving empiric antibiotics remain unclear and clinical equipoise is suggested.
Infants in category i. and ii. will be excluded for randomization and included in the observational part of the study; these patients will be further treated according to the Dutch EOS guideline. Infants in category iii. are eligible to be included in the RCT-part of the study.
RANDOMIZATION
Included category iii infants will be evaluated for EOS with blood culture and randomly assigned (1:1) to one of the following study groups:
Intervention-group, presepsin-guided therapy: The decision to start empirical antibiotics in this group will be based on presepsin measurement within four hours after birth. When the presepsin value is above the cut-off value of 645 pg/ml, antibiotics will be ordered and administered within 4 hours of life and discontinued following the criteria of the Dutch EOS guideline. Cessation of antibiotic treatment typically occurs when blood culture results remain sterile within 3 days after birth.
When the presepsin level is below the cut-off value of 645 pg/ml, the treating physician will not start antibiotic treatment. These infants will be closely observed for at least 72 hours. In case of deterioration of the clinical condition within this observation period, the clinician can decide to perform a sepsis evaluation and start with antibiotic treatment. Investigators anticipate that <5% of infant subjects will experience worsening of conditions. When the initial blood culture in this group turns back positive without clinical signs and symptoms of EOS sepsis, a new blood culture and antibiotic treatment will be advised.
Comparator-group, standard care: Standard care according to the Dutch EOS guideline. Presepsin will be determined with the treating physician blinded for the test result. In the Dutch EOS guideline maternal and neonatal risk factors for EOS are categorized as red flags or minor criteria. In the presence of 1 red flag or ≥ 2 minor criteria it is advised to perform a blood culture (= sepsis evaluation) and start empirical antibiotics for EOS suspicion.2 Antibiotic treatment will be advised to discontinue when blood culture turns back negative, reassuring the infants clinical condition with no other indicators of possible infection (e.g. CRP).
Randomization will be performed centrally, using web-based block randomization stratified by study site with random permuted blocks within the strata. Randomization sequence is generated using Castor EDC, which is regulatory compliant software, ensuring allocation concealment. Multiples (i.e. siblings) will be randomized to the same treatment arm.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Presepsin-guided therapy | Experimental | Diagnostic Test: PresepsinThe decision to start empirical antibiotics in this group will be based on presepsin measurement within four hours after birth. When the presepsin value is above the cut-off value of 645 pg/ml, antibiotics will be ordered and administered within 4 hours of life and discontinued following the criteria of the Dutch EOS guideline. When the presepsin level is below the cut-off value of 645 pg/ml, the treating physician will not start antibiotic treatment. These infants will be closely observed for at least 72 hours. In case of deterioration of the clinical condition within this observation period, the clinician can decide to perform a sepsis evaluation and start with antibiotic treatment. |
| Standard care | Active comparator | Diagnostic Test: Standard CareStandard care according to the Dutch EOS guideline. Presepsin will be determined with the treating physician blinded for the test result. In the Dutch EOS guideline maternal and neonatal risk factors for EOS are categorized as red flags or minor criteria. In the presence of 1 red flag or ≥ 2 minor criteria it is advised to perform a blood culture (= sepsis evaluation) and start empirical antibiotics for EOS suspicion. Antibiotic treatment will be advised to discontinue when blood culture turns back negative, reassuring the infants clinical condition with no other indicators of possible infection (e.g. CRP). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Infants born at a gestational age of 24+0 to 31 6/7 weeks
- Moderate risk of early-onset neonatal sepsis, i.e. infants who should be treated with empirical antibiotics based on the Dutch EOS guideline.
Key exclusion criteria (7 listed)
- low risk of early-onset neonatal sepsis who do not have an indication for empirical antibiotics according to the Dutch EOS guideline;
- high risk of early-onset neonatal sepsis defined as:
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 |
|---|---|---|
| PresepsinUmbilical cord blood or blood from the first routine venous puncture within four hours after birth will be used for presepsin determination. Presepsin measurement can be performed in 100 μl plasma with "PATHFAST™ Presepsin" which is a rapid chemiluminescent enzyme immunoassay (Mitsubishi Chemical Medience corporation, Tokyo, Japan) with results available within 15 minutes. | Diagnostic test | Presepsin-guided therapy |
| Standard CareStandard care according to the Dutch EOS guideline | Diagnostic test | Standard care |
Primary outcome
the incidence of culture-proven early-onset sepsis
Time frame: 72 hours after birth
non-inferiority
presence of unnecessary antibiotics prescription
Time frame: 72 hours after birth
antibiotic administration for ≤3 days when started within the first 72 hours after birth (superiority)
5 secondary outcomes
sepsis-associated severity of illness (nSOFA)
Time frame: from birth until discharge from initial hospital (up to 6 months)
sepsis-associated severity of illness (meningitis)
Time frame: from birth until discharge from initial hospital (up to 6 months)
sepsis-associated severity of illness (death)
Time frame: from birth until discharge from initial hospital (up to 6 months)
total number of antibiotic days when started < 72 hours after birth
Time frame: from birth until discharge from initial hospital (up to 6 months)
Presence of necrotizing enterocolitis and/or late-onset sepsis and/or death
Time frame: from birth until discharge from initial hospital (up to 6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Derived from this study: PubMed 41749329Nusman CM, Taal HR, Vijlbrief DC, Bekker V, van Mechelen KWG, de Boode WP, Hemels MAC, Flores CML, Roescher AM, Nuytemans DHGM, Obermann-Borst SA, van der Flier M, van Bodegom-Vos L, Ramakers CRB, Schotman HHM, de Borgie CAJM, Merkus MP, Leeflang MMG, van Kaam AH, Onland W, Visser DH. Presepsin to safely reduce antibiotics in preterm infants (PRESAFE): study protocol for a randomized controlled trial with a concurrent observational study. Trials. 2026 Feb 27;27(1):267. doi: 10.1186/s13063-026-09515-8.
- Individual participant dataSharing planned: Yes
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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.
Douwe Visser, MD PhD principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Presepsin in people with Early-Onset Neonatal Sepsis, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 2 Oct 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Douwe Visser, MD PhD (+31205669111, d.h.visser@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of culture-proven early-onset sepsis (time frame: 72 hours after birth). The study lists 2 primary outcomes in all. 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 NCT06100614, which also lists 1 linked publication.
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 2 Oct 2025.