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

5. november 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

500

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Antwerp
      • Edegem, Antwerp, Belgien, 2650
        • Antwerp University Hospital
        • Kontakt:
      • Amsterdam, Holland
        • Amsterdam UMC
      • Rotterdam, Holland
        • Erasmus MC Rotterdam

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The time between the last Intellicens Neo visual alert preceding LOS/NEC diagnosis and the timepoint of administration of IV antibiotics.
Tidsramme: 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.
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The time between the last Intellicens Neo visual alert preceding LOS/NEC diagnosis and the timepoint of LOS/NEC diagnosis.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

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Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

9. november 2026

Primær færdiggørelse (Anslået)

31. marts 2028

Studieafslutning (Anslået)

31. marts 2028

Datoer for studieregistrering

Først indsendt

31. oktober 2026

Først indsendt, der opfyldte QC-kriterier

5. november 2026

Først opslået (Faktiske)

12. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. november 2026

Sidst verificeret

1. november 2026

Mere information

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