Neonatal AI-Based Early Warning System for Late-Onset Sepsis and Necrotizing Enterocolitis in the NICU: Assessment of Response and Effectiveness (NEO-AWARE)

November 5, 2026 updated by: Karlijn Van Damme, University Hospital, Antwerp

Neonatal AI-Based Early Warning System for Late-Onset Sepsis and Necrotizing Enterocolitis in the NICU: Assessment of Response and Effectiveness in a Post-Implementation Prospective Study With Pre-Implementation Historical Comparison

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • Antwerp University Hospital
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam UMC
      • Rotterdam, Netherlands
        • Erasmus MC Rotterdam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Neonates born below a gestational age of 32 weeks
  • Admitted to the NICU
  • Written informed consent

Exclusion Criteria:

  • Severe congenital malformations
  • Admission for palliative care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intellicens Neo implementation group

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The time between the last Intellicens Neo visual alert preceding LOS/NEC diagnosis and the timepoint of administration of IV antibiotics.
Time Frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.

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.
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.
Time Frame: Within 3 hours after each visual alert during the NICU stay. From postnatal day 3, with an estimated maximum of 25 weeks.

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.
Within 3 hours after each visual alert during the NICU stay. From postnatal day 3, with an estimated maximum of 25 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The time between the last Intellicens Neo visual alert preceding LOS/NEC diagnosis and the timepoint of LOS/NEC diagnosis.
Time Frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.

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.
From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Incidence of severe LOS/NEC.
Time Frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.

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.
From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Length of NICU stay
Time Frame: From birth until NICU discharge, with an estimated maximum of 25 weeks.

Total duration of the patient's stay in the neonatal intensive care unit (NICU), measured from NICU admission to NICU discharge.
From birth until NICU discharge, with an estimated maximum of 25 weeks.
Total duration of intravenous antibiotic therapy
Time Frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.

Total number of days of intravenous antibiotic treatment during the patient's NICU stay.
From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Number of suspected LOS episodes
Time Frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.

Total number of suspected late-onset sepsis (LOS) episodes recorded during the patient's NICU stay.
From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
LOS/NEC-related mortality
Time Frame: Within 7 days after LOS/NEC diagnosis.

Occurrence of mortality related to late-onset sepsis (LOS) or necrotizing enterocolitis (NEC), defined as mortality occurring within 7 days after LOS/NEC diagnosis.
Within 7 days after LOS/NEC diagnosis.
Performance of the Intellicens Neo software device ML model on the prospective dataset: sensitivity
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, defined as the sensitivity/recall of the ML model: the percentage of detected LOS/NEC episodes by the Intellicens Neo software device
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
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, defined as the specificity of the ML model
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
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, 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
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
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, defined as the visual alert rate of the ML model: total number of alert days per patient per week.
From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Number needed to predict
Time Frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.

Number of patients who need to be examined to detect one patient with the relevant disease (LOS or NEC).
From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.
Time from LOS/NEC diagnosis to intravenous antibiotic treatment
Time Frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.

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.
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
Time Frame: Within 1 hour after each visual alert during the NICU stay. From postnatal day 3, with an estimated maximum of 25 weeks.

The proportion of Intellicens Neo visual alerts that are acknowledged by the clinical care team within 1 hour after the visual alert is generated.
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
Time Frame: Within 6 hours after each visual alert during the NICU stay. From postnatal day 3, with an estimated maximum of 25 weeks.

The proportion of Intellicens Neo visual alerts that are acknowledged by the clinical care team within 6 hours after the visual alert is generated.
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
Time Frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.

The proportion of all Intellicens Neo visual alerts that are acknowledged by the clinical care team, irrespective of the time taken to acknowledge them.
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
Time Frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.

The proportion of Intellicens Neo visual alerts that are followed by a clinical action related to suspected LOS or NEC.
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
Time Frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.

The proportion of Intellicens Neo visual alerts that are followed by laboratory evaluation for suspected late-onset sepsis (LOS) or necrotizing enterocolitis (NEC).
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
Time Frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.

The proportion of Intellicens Neo visual alerts that are followed by initiation of intravenous antibiotic treatment for suspected LOS or NEC.
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
Time Frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.

The proportion of Intellicens Neo visual alerts that are dismissed by the clinical care team.
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
Time Frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.

The time interval between an Intellicens Neo visual alert and the first clinical action related to that alert.
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
Time Frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.

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).
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
Time Frame: From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.

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.
From postnatal day 3 until NICU discharge, with an estimated maximum of 25 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Antwerp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTMS 4631
  • CIV-26-06-059054 (Other Identifier: EUDAMED Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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