Neonatal AI-Based Early Warning System for Late-Onset Sepsis and Necrotizing Enterocolitis in the NICU: Assessment of Response and Effectiveness
NCT07931144, Not applicable, Not yet recruiting, University Hospital, Antwerp
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Neonatal AI-Based Early Warning System for Late-Onset Sepsis and Necrotizing Enterocolitis in the NICU: Assessment of Response and Effectiveness | ClinicalTrials.gov |
| NCT number | NCT07931144 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 500 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Hospital, Antwerp | ClinicalTrials.gov |
| Conditions | Late Onset Neonatal Sepsis, Necrotizing Enterocolitis of Newborn | ClinicalTrials.gov |
| Interventions | Intellicens Neo software | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | The time between the last Intellicens Neo visual alert preceding LOS/NEC diagnosis and the timepoint of administration of IV antibiotics. | 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. | ClinicalTrials.gov |
| Primary | Substudy: Proportion of Intellicens Neo visual alerts acknowledged by the clinical care team within 3 hours. | 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. | ClinicalTrials.gov |
| Secondary | The time between the last Intellicens Neo visual alert preceding LOS/NEC diagnosis and the timepoint of LOS/NEC diagnosis. | 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. | ClinicalTrials.gov |
| Secondary | Incidence of severe LOS/NEC. | 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. | ClinicalTrials.gov |
| Secondary | Length of NICU stay | 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. | ClinicalTrials.gov |
| Secondary | Total duration of intravenous antibiotic therapy | 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. | ClinicalTrials.gov |
| Secondary | Number of suspected LOS episodes | 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. | ClinicalTrials.gov |
| Secondary | LOS/NEC-related mortality | 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. | ClinicalTrials.gov |
| Secondary | Performance of the Intellicens Neo software device ML model on the prospective dataset: sensitivity | 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 | ClinicalTrials.gov |
| Secondary | Performance of the Intellicens Neo software device ML model on the prospective dataset: specificity | 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 | ClinicalTrials.gov |
| Secondary | Performance of the Intellicens Neo software device ML model on the prospective dataset: precision | 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 | ClinicalTrials.gov |
| Secondary | Performance of the Intellicens Neo software device ML model on the prospective dataset: visual alert rate | 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. | ClinicalTrials.gov |
| Secondary | Number needed to predict | 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). | ClinicalTrials.gov |
| Secondary | Time from LOS/NEC diagnosis to intravenous antibiotic treatment | 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. | ClinicalTrials.gov |
| Secondary | Substudy: Proportion of Intellicens Neo visual alerts acknowledged by the clinical care team within 1 hour | 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. | ClinicalTrials.gov |
| Secondary | Substudy: Proportion of Intellicens Neo visual alerts acknowledged by the clinical care team within 6 hours | 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. | ClinicalTrials.gov |
| Secondary | Substudy: Proportion of Intellicens Neo visual alerts acknowledged by the clinical care team | 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. | ClinicalTrials.gov |
| Secondary | Substudy: Proportion of Intellicens Neo visual alerts leading to clinical action | 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. | ClinicalTrials.gov |
| Secondary | Substudy: Proportion of Intellicens Neo visual alerts leading to laboratory evaluation for LOS/NEC suspicion | 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). | ClinicalTrials.gov |
| Secondary | Substudy: Proportion of Intellicens Neo visual alerts leading to initiation of intravenous antibiotic treatment | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 38065281 | BACKGROUND | PubMed |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.