Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
NCT07920718, Not yet recruiting, Guangzhou Women and Children's Medical Center
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping | ClinicalTrials.gov |
| NCT number | NCT07920718 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 1,600 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Guangzhou Women and Children's Medical Center | ClinicalTrials.gov |
| Conditions | Acute Respiratory Distress Syndrome | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Sensitivity of high-priority review for the high-likelihood NARDS-compatible clinical phenotype | One assessment per first eligible respiratory event, using records from 48 hours before to 48 hours after the first screening trigger (T0). | The investigators will calculate the high-priority proportion among expert-adjudicated NARDS-compatible infants, excluding routine-review and insufficient-information outputs, and report performance with 95% CIs by cohort, with uncertain assessments reported separately. | ClinicalTrials.gov |
| Secondary | Positive predictive value of high-priority review | One assessment per first eligible respiratory event, using records from 48 hours before to 48 hours after T0. | Among high-priority infants with determinate reference, report adjudicated high-likelihood NARDS-compatible proportion and 95% CI by cohort. Enriched samples yield sampling-weighted candidate estimates if permitted. It is not NICU-wide incidence. | ClinicalTrials.gov |
| Secondary | Negative predictive value for the high-priority triage policy | One assessment per first eligible respiratory event, using records from 48 hours before to 48 hours after T0. | Among determinate-reference non-high-priority infants, report non-compatible phenotype proportion and 95%CI by cohort; describe routine-review and insufficient-information outputs separately, to avoid concealment. Weight historical estimates if possible. | ClinicalTrials.gov |
| Secondary | Proportion of infants with a determinate reference-standard assessment | At reference adjudication of the first eligible event, using the same records from 48 hours before to 48 hours after T0. | Assessed infants with high-likelihood NARDS-compatible or non-compatible phenotype divided by all assessed; uncertain and insufficient-information assessments reported separately with reasons and 95% CIs, not relabeled negative or removed from flow. | 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 |
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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 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
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 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
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.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)