An interventional study of Intellicens Neo software in Late Onset Neonatal Sepsis and Necrotizing Enterocolitis of Newborn, sponsored by University Hospital, Antwerp. Not yet recruiting at 3 sites in 2 countries. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Other
Among 10 studies in Neonatal Sepsis with a site in Netherlands — 7 open to participants now, 8 under way, none of them phase 3. Neonatal Sepsis · Netherlands.
Among the 10 studies in Neonatal Sepsis with a site in Netherlands, this one is the only one that started in 2026, is one of 3 with no phase, and was the 10th registered.
193 studies on the registry are indexed under Neonatal Sepsis; 42 are open to participants now.
Browse Neonatal Sepsis studies →7 of the 10 studies in Neonatal Sepsis with a site in Netherlands are open now. Recruiting first, the newest first:
Maxima Medical Center · Sites in Netherlands
Ages 16+ · Women only · Healthy volunteers
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Sites in Netherlands
Jip Groen · Sites in Netherlands
Ages 0–18
Franciscus Gasthuis · Sites in Netherlands
Ages up to 3 days
Jip Groen · Sites in Netherlands
Ages up to 90 days
A study can be open while its sites in Netherlands have not opened yet or have stopped. Only those recruiting at a site in Netherlands →
Of the 23 Neonatal Sepsis studies recruiting now, 8 (35%) set no upper age limit and 15 (65%) stop at 75 or younger; 20 take children under 18; 2 take healthy volunteers.
This study: all sexes · healthy volunteers too.
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10 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 500 is above the median of 182 across 103 interventional studies indexed under Neonatal Sepsis.
Median enrollment 510 across the 5 interventional studies, 1,835 across the 5 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
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None of the 10 has an industry lead sponsor. The 8 most frequent:
University Hospital, Antwerp is the lead sponsor of 243 studies on the registry; 66 are open to participants now.
University Hospital, Antwerp has 1 study filed under Neonatal Sepsis — fewer than ten, so there is no comparison to draw.
1 of the studies in Neonatal Sepsis with a site in Netherlands that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06100614Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Presepsin to Safely Reduce Antibiotics in Preterm Infants | 2027-01-01 |
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Among the 10 studies in Neonatal Sepsis with a site in Netherlands, from their registry updates:
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This study aims to evaluate the Intellicens software, an artificial intelligence (AI)-based early warning system designed to help doctors and nurses detect serious complications in premature babies at an early stage. These complications include bloodstream infections (sepsis) and necrotizing enterocolitis (NEC), a serious condition affecting the intestines.
The study will involve babies born before 32 weeks of pregnancy who are admitted to the Neonatal Intensive Care Unit (NICU). The Intellicens Neo model analyses routinely collected medical data, such as heart rate, to identify patterns that may indicate an increased risk of sepsis or NEC and generate an early warning for healthcare professionals. The treating doctor remains responsible for deciding whether further examinations or treatment are needed.
The software has previously been tested using data from babies who had already been discharged from hospital, with promising results. This study will evaluate how well the software performs in real-life clinical practice during the hospital stay.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Preterm infants born at less than 32 weeks of gestational age admitted to participating neonatal intensive care units (NICUs) after implementation of Intellicens Neo. The software generates visual alerts for potential late-onset sepsis (LOS) and necrotizing enterocolitis (NEC). Alerts are visible to the clinical care team, while clinical assessment and treatment decisions remain at the discretion of the treating clinicians. Study outcomes will be compared with a historical pre-implementation dataset.
Device: Intellicens Neo software
Intellicens Neo is investigational medical device software designed to support early warning of late-onset sepsis (LOS) and necrotizing enterocolitis (NEC) in preterm infants admitted to the neonatal intensive care unit (NICU). The software calculates a NeoSep Index every 30 minutes and generates visual alerts when predefined alert criteria are met. The alerts are made visible to the clinical care team to support awareness of potential LOS or NEC. Clinical assessment and treatment decisions remain at the discretion of the treating clinicians. The intervention is evaluated in a prospective, multicenter, post-implementation clinical investigation, with outcomes compared with a pre-implementation historical dataset.
The time between the last Intellicens Neo visual alert preceding LOS/NEC diagnosis and the timepoint of administration of IV antibiotics.
The time interval between the last Intellicens Neo visual alert preceding the diagnosis of late-onset sepsis (LOS) or necrotizing enterocolitis (NEC) and the administration of intravenous antibiotics for that episode. This outcome evaluates whether the availability of Intellicens Neo alerts is associated with earlier initiation of antibiotic treatment in preterm infants with LOS or NEC.
Time frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Substudy: Proportion of Intellicens Neo visual alerts acknowledged by the clinical care team within 3 hours.
Primary outcome in the substudy, analysis done only in the first 150 patients enrolled. The proportion of Intellicens Neo visual alerts that are acknowledged by the clinical care team within 3 hours after the visual alert is generated.
Time frame: Within 3 hours after each visual alert during the NICU stay. From postnatal day 3, with an estimated maximum of 25 weeks.
The time between the last Intellicens Neo visual alert preceding LOS/NEC diagnosis and the timepoint of LOS/NEC diagnosis.
The time interval between the start of the last Intellicens Neo visual alert preceding a LOS/NEC episode and the time of LOS/NEC diagnosis. The time of diagnosis is defined as the time of the blood culture order in the patient's electronic health record.
Time frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Incidence of severe LOS/NEC.
Occurrence of severe late-onset sepsis (LOS) or necrotizing enterocolitis (NEC) episodes in the study population. The number of severe LOS/NEC episodes will be compared between the prospective cohort and the pre-implementation historical cohort.
Time frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Length of NICU stay
Total duration of the patient's stay in the neonatal intensive care unit (NICU), measured from NICU admission to NICU discharge.
Time frame: From birth until NICU discharge, with an estimated maximum of 25 weeks.
Total duration of intravenous antibiotic therapy
Total number of days of intravenous antibiotic treatment during the patient's NICU stay.
Time frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Number of suspected LOS episodes
Total number of suspected late-onset sepsis (LOS) episodes recorded during the patient's NICU stay.
Time frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
LOS/NEC-related mortality
Occurrence of mortality related to late-onset sepsis (LOS) or necrotizing enterocolitis (NEC), defined as mortality occurring within 7 days after LOS/NEC diagnosis.
Time frame: Within 7 days after LOS/NEC diagnosis.
Performance of the Intellicens Neo software device ML model on the prospective dataset: sensitivity
Performance of the Intellicens Neo software device ML model on the prospective dataset, defined as the sensitivity/recall of the ML model: the percentage of detected LOS/NEC episodes by the Intellicens Neo software device
Time frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Performance of the Intellicens Neo software device ML model on the prospective dataset: specificity
Performance of the Intellicens Neo software device ML model on the prospective dataset, defined as the specificity of the ML model
Time frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Performance of the Intellicens Neo software device ML model on the prospective dataset: precision
Performance of the Intellicens Neo software device ML model on the prospective dataset, defined as the precision of the ML model: the amount of (false positive) visual alerts generated by the Intellicens Neo software device represented by the total number of 24-hour time-windows in which a false positive visual alert occurred
Time frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Performance of the Intellicens Neo software device ML model on the prospective dataset: visual alert rate
Performance of the Intellicens Neo software device ML model on the prospective dataset, defined as the visual alert rate of the ML model: total number of alert days per patient per week.
Time frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Number needed to predict
Number of patients who need to be examined to detect one patient with the relevant disease (LOS or NEC).
Time frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Time from LOS/NEC diagnosis to intravenous antibiotic treatment
The time interval between the time of LOS/NEC diagnosis, defined as the time of the blood culture order in the patient's electronic health record, and the time of intravenous antibiotic treatment, defined as the time of the order of the first dose of intravenous antibiotics in the patient's electronic health record.
Time frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Substudy: Proportion of Intellicens Neo visual alerts acknowledged by the clinical care team within 1 hour
The proportion of Intellicens Neo visual alerts that are acknowledged by the clinical care team within 1 hour after the visual alert is generated.
Time frame: Within 1 hour after each visual alert during the NICU stay. From postnatal day 3, with an estimated maximum of 25 weeks.
Substudy: Proportion of Intellicens Neo visual alerts acknowledged by the clinical care team within 6 hours
The proportion of Intellicens Neo visual alerts that are acknowledged by the clinical care team within 6 hours after the visual alert is generated.
Time frame: Within 6 hours after each visual alert during the NICU stay. From postnatal day 3, with an estimated maximum of 25 weeks.
Substudy: Proportion of Intellicens Neo visual alerts acknowledged by the clinical care team
The proportion of all Intellicens Neo visual alerts that are acknowledged by the clinical care team, irrespective of the time taken to acknowledge them.
Time frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Substudy: Proportion of Intellicens Neo visual alerts leading to clinical action
The proportion of Intellicens Neo visual alerts that are followed by a clinical action related to suspected LOS or NEC.
Time frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Substudy: Proportion of Intellicens Neo visual alerts leading to laboratory evaluation for LOS/NEC suspicion
The proportion of Intellicens Neo visual alerts that are followed by laboratory evaluation for suspected late-onset sepsis (LOS) or necrotizing enterocolitis (NEC).
Time frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Substudy: Proportion of Intellicens Neo visual alerts leading to initiation of intravenous antibiotic treatment
The proportion of Intellicens Neo visual alerts that are followed by initiation of intravenous antibiotic treatment for suspected LOS or NEC.
Time frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Substudy: Proportion of Intellicens Neo visual alerts dismissed by the clinical care team
The proportion of Intellicens Neo visual alerts that are dismissed by the clinical care team.
Time frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Substudy: Time from Intellicens Neo visual alert to the first related clinical action
The time interval between an Intellicens Neo visual alert and the first clinical action related to that alert.
Time frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Substudy: Association between time of day and time to visual alert acknowledgement
Evaluation of the effect of time of day on the time to acknowledgement of Intellicens Neo visual alerts. Time periods are defined as day shift (08:30-17:00), evening shift (17:00-23:00), and night shift (23:00-08:30).
Time frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Substudy: Association between Intellicens Neo alert burden and time to visual alert acknowledgement
Evaluation of the effect of alert burden on the time to acknowledgement of Intellicens Neo visual alerts. Alert burden is defined as the presence of at least 2 visual alerts in the same patient during the preceding week.
Time frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Plan to share: No
Start is estimated for Nov 2026; primary completion for Mar 2028, 16 months later.
Of 30 interventional studies with no phase under Neonatal Sepsis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 16 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Antwerp →