Early-Onset Neonatal SepsisPROPOSENCT05796115
PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of EOS
A study testing Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS and Antibiotic prophylaxis for EOS in people with Early-Onset Neonatal Sepsis, run by University of Florence.
Trial summary
The goal of this randomized controlled study is to compare the outcome of preterm infants who will receive the standard antibiotic prophylaxis for EOS or Procalcitonin/Presepsin-guided antibiotic prophylaxis of early onset sepsis (EOS). Read more about this study
- Who is it for?
- Ages 0 to 3 hours
- Conditions the study is for
- Early-Onset Neonatal Sepsis
- What is being tested?
- Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS and Antibiotic prophylaxis for EOS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 30 Sep 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 0 to 3 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants of 25+0- 31+6 weeks of gestational age will be enrolled in the study.
Who cannot join
- Risk factors for EOS:
- maternal GBS colonization without adequate prophylaxis;
- clinical chorioamnionitis diagnosed by maternal intrapartum fever (either a single documented maternal intrapartum temperature of ≥39.0°C or a temperature of 38.0-38.9°C that persists for >30 minutes) and 1 or more of the following: (1) maternal leukocytosis, (2) purulent cervical drainage, and (3) fetal tachycardia;
- pre-labor rupture of membranes (ROM) >1 h before delivery.
- Surgery within the first week of life,
- major congenital malformations,
Show all 9Show fewer
- chromosomal syndromes,
- inherited metabolic disorders,
- fetal hydrops
Trial locations and contacts
No sites are listed yet.
About this study
Official title: PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of Early-Onset SEpsis in Preterm Infants: a Multicentre, Randomised Controlled Trial
The goal of this randomized controlled study is to compare the outcome of preterm infants who will receive the standard antibiotic prophylaxis for EOS or Procalcitonin/Presepsin-guided antibiotic prophylaxis of early onset sepsis (EOS).
The main question it aims to answer is:
Read more
- Does Procalcitonin/Presepsin-guided antibiotic prophylaxis of (EOS) increase survival without major morbidities, including IVH >3 grade, PVL, ROP >3 grade in either eye, NEC >2 grade, BPD, or LOS.
Infants with gestational age between 25+0 and 31+6 weeks of gestation or a birth weight <1500 g will be eligible for enrollment in the study.
Participants will be randomized to receive standard antibiotic prophylaxis for EOS (standard group) or to receive antibiotic prophylaxis for EOS on the basis of PCT/P-SEP measured within 3 h of life (intervention group).
- Conditions
- Early-Onset Neonatal Sepsis
- Being tested
- Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS, Antibiotic prophylaxis for EOS
- Keywords
- Early-Onset Sepsis, Procalcitonin, Presepsin, Preterm infant
- Medical subject headings
- Neonatal Sepsis, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procalcitonin/Presepsin guided antibiotic prophylaxis for EOSProcedure or surgery
Infants will receive antibiotic prophylaxis for EOS on the basis of Procalcitonin and Presepsin values measured within the first 3 hours of life.
Antibiotic prophylaxis for EOSProcedure or surgery
Infants will receive antibiotic prophylaxis for EOS.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic prophylaxis for EOS | Active comparator | Not described Receives: Procedure: Antibiotic prophylaxis for EOS |
| Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS | Experimental | Not described Receives: Procedure: Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival without major morbidities.
Survival without IVH >/=3 grade, PVL, ROP >3 grade in either eye, NEC >2 grade, BPD, or LOS.
Measured: Participants will be monitored for the duration of hospital stay which is an average of 10 weeks
Secondary outcomes (1)
Individual components of the composite primary outcome will be regarded as secondary outcomes.
Occurrence of IVH >/=3 grade, PVL, ROP >3 grade in either eye, NEC >2 grade, BPD, or LOS.
Measured: Participants will be monitored for the duration of hospital stay which is an average of 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Apr 2023 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-Onset Neonatal SepsisStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Dani, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796115
- Sponsor's protocol ID
- PROPOSE02
- Acronym
- PROPOSE
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROcalcitonin and Presepsin-guided Decision for Antibiotic Prophylaxis of Early-Onset SEpsis in Preterm Infants: a Multicentre, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05796115
- Acronym / sponsor ID
- PROPOSE / PROPOSE02
- Conditions
- Early-Onset Neonatal Sepsis
- Keywords
- Early-Onset Sepsis, Procalcitonin, Presepsin, Preterm infant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 3 Apr 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.
The goal of this randomized controlled study is to compare the outcome of preterm infants who will receive the standard antibiotic prophylaxis for EOS or Procalcitonin/Presepsin-guided antibiotic prophylaxis of early onset sepsis (EOS).
The main question it aims to answer is:
- Does Procalcitonin/Presepsin-guided antibiotic prophylaxis of (EOS) increase survival without major morbidities, including IVH >3 grade, PVL, ROP >3 grade in either eye, NEC >2 grade, BPD, or LOS.
Infants with gestational age between 25+0 and 31+6 weeks of gestation or a birth weight <1500 g will be eligible for enrollment in the study.
Participants will be randomized to receive standard antibiotic prophylaxis for EOS (standard group) or to receive antibiotic prophylaxis for EOS on the basis of PCT/P-SEP measured within 3 h of life (intervention group).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic prophylaxis for EOS | Active comparator | Procedure: Antibiotic prophylaxis for EOS |
| Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS | Experimental | Procedure: Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS |
Who may qualify
- Ages
- 0 to 3 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- infants of 25+0- 31+6 weeks of gestational age will be enrolled in the study.
Key exclusion criteria (9 listed)
- Risk factors for EOS:
- Surgery within the first week of life,
- major congenital malformations,
- chromosomal syndromes,
- inherited metabolic disorders,
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 |
|---|---|---|
| Procalcitonin/Presepsin guided antibiotic prophylaxis for EOSInfants will receive antibiotic prophylaxis for EOS on the basis of Procalcitonin and Presepsin values measured within the first 3 hours of life. | Procedure or surgery | Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS |
| Antibiotic prophylaxis for EOSInfants will receive antibiotic prophylaxis for EOS. | Procedure or surgery | Antibiotic prophylaxis for EOS |
Primary outcome
Survival without major morbidities.
Time frame: Participants will be monitored for the duration of hospital stay which is an average of 10 weeks
Survival without IVH >/=3 grade, PVL, ROP >3 grade in either eye, NEC >2 grade, BPD, or LOS.
1 secondary outcome
Individual components of the composite primary outcome will be regarded as secondary outcomes.
Time frame: Participants will be monitored for the duration of hospital stay which is an average of 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Procalcitonin/Presepsin guided antibiotic prophylaxis for EOS and Antibiotic prophylaxis for EOS in people with Early-Onset Neonatal Sepsis, run by University of Florence.
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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlo Dani (0039 055 7948421, carlo.dani@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival without major morbidities. (time frame: Participants will be monitored for the duration of hospital stay which is an average of 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2023.