Acute Respiratory Distress SyndromeNCT07920718
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
An observational study of Acute Respiratory Distress Syndrome, run by Guangzhou Women and Children's Medical Center.
Trial summary
Neonatal acute respiratory distress syndrome (NARDS) can be difficult to identify consistently because relevant information is distributed across clinical notes, imaging reports, and respiratory support records. Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 1,600 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2026to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 days
- All sexes
- No healthy volunteers
- Child
Study population: Infants in NICU at 3 participating hospitals before 44 weeks' postmenstrual age whose records meet ≥1 prespecified screening criterion for possible acute pulmonary injury. Historical candidates are sampled from prespecified center/calendar strata. The prospective phase consecutively enrolls newly eligible infants after system locking and retrospective validation. Separately identified screen-negative infants are reviewed if included in the registered screening audit. TTN, RDS, PPHN, pneumonia, and pulmonary hemorrhage are not automatic exclusions by diagnosis alone. Independent adjudication determines whether an alternative condition fully explains findings. Missing key evidence yields an uncertain/insufficient-information assessment, not automatic exclusion or a negative disease label.
Who may be able to join
- Receiving care in the NICU of a participating hospital before 44 weeks of postmenstrual age at the index event.
- Meeting at least one prespecified candidate screening criterion, including a relevant acute lung injury or NARDS/ARDS expression, respiratory support or support escalation, bilateral or diffuse pulmonary parenchymal abnormalities in an imaging report, or a prespecified acute lung injury trigger.
- Having records within the prespecified center and calendar-period cohort, or being newly eligible during the approved prospective validation period.
- Availability of an appropriate legal basis for use of the records, including parental or guardian consent or an ethics-approved waiver when applicable.
Who cannot join
- Structural lung or airway malformations, complex congenital heart disease, or clearly established cardiac dysfunction or fluid overload that fully explains the respiratory failure and imaging abnormalities.
- Short-term postoperative mechanical ventilation without evidence of acute pulmonary injury.
- Duplicate or unresolvable records that prevent reliable identification of the infant or index event.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Development and Multicenter Validation of an Explainable System for Identifying Clinical Phenotypes Compatible With Neonatal Acute Respiratory Distress Syndrome
Neonatal acute respiratory distress syndrome (NARDS) can be difficult to identify consistently because relevant information is distributed across clinical notes, imaging reports, and respiratory support records. This study will develop and validate an explainable system that organizes routinely collected electronic health record information and identifies infants whose clinical findings are compatible with NARDS.
The study will involve three neonatal intensive care units in China. Historical records from the lead center will be used for system development. A later period at the lead center and independent records from the two collaborating centers will be used for temporal and geographic validation. After the system has been locked, newly eligible infants will be included in a prospective validation phase without changing their clinical care.
System results will be compared with an independent reference assessment by neonatal intensive care specialists. The specialists will classify each infant's first eligible respiratory event as a high-likelihood NARDS-compatible clinical phenotype, a non-compatible clinical phenotype, clinically uncertain, or insufficient information. The study will evaluate sensitivity, specificity, predictive values, review workload, and the ability to identify insufficient information. During prospective validation, system results will remain unavailable to treating clinicians. The system is being evaluated as a research screening and review tool; it is not intended to replace a full clinical diagnosis or to determine treatment.
Read the detailed description
Study design and objective This is a three-center observational cohort study combining retrospective system development and validation with prospective validation of a locked system. Its objective is to develop an explainable electronic health record-based system for identifying a NARDS-compatible clinical phenotype and prioritizing candidate records for specialist review.
Establishment of retrospective cohorts Historical NICU records dated January 1, 2018, through December 31, 2025, will provide the retrospective source population. Records from the lead center dated 2018-2022 will form the development cohort. Records from the lead center dated 2023-2025 will form an independent internal temporal validation cohort. Records from each collaborating center dated 2023-2025 will form two separate geographic external validation cohorts. The planned formal adjudication sample is approximately 1,600 candidate events for development and 800 candidate events in each of the three retrospective validation cohorts. Each infant's first eligible event will be used in the primary analysis.
Candidate screening and sampling Candidate records will be identified using prespecified evidence of respiratory support or escalation, bilateral or diffuse pulmonary imaging abnormalities, acute lung injury triggers, or relevant diagnostic expressions. Diagnostic codes will be used for screening and descriptive analyses.
System development and locking The system will extract traceable evidence from imaging reports and other permitted clinical records, including acute respiratory deterioration, acute lung injury triggers, pulmonary imaging abnormalities, and alternative explanations. It will assign high-priority review, routine review, or insufficient-information status and retain the supporting source and timestamp. The variable dictionary, text-processing rules, feature mappings, decision rules, thresholds, software version, and analysis plan will be locked before validation. No retraining, threshold selection, or center-specific tuning will use validation labels.
Reference standard Two qualified neonatal intensive care specialists will independently assess each evidence package using a prespecified adjudication manual. Disagreement will undergo independent arbitration and, when necessary, structured consensus. Adjudicators will be masked to system outputs, explanations, discharge diagnostic labels, and diagnostic codes. They will assign one of four categories: high-likelihood NARDS-compatible clinical phenotype, non-compatible clinical phenotype, clinically uncertain, or insufficient information. The high-likelihood phenotype requires an acute respiratory course, evidence of an acute lung injury trigger, bilateral or diffuse pulmonary parenchymal imaging abnormalities, and no single alternative explanation that fully accounts for the findings.
Prospective validation After retrospective temporal and geographic validation, the same locked system will be assessed in newly eligible infants at the participating centers. The proposed prospective phase will include consecutive eligible infants and will preserve the same index-event definition, evidence window, reference standard, and output categories. Results will be generated in silent mode and will not be displayed to treating clinicians or used to guide care. Independent adjudicators will remain masked to system outputs. Prospective sample size, center participation, recruitment dates, and consent arrangements will be finalized in the protocol and ethics documentation before this phase begins.
Performance analysis The primary measure will be sensitivity of high-priority review for the reference-standard high-likelihood phenotype in each independent validation cohort. Results will be presented separately for the lead-center temporal cohort, each external center, and the prospective phase, with center-specific prospective results when sample size permits. Ninety-five percent confidence intervals will accompany performance estimates. Sampling weights will be used when estimating performance in the historical candidate population. These categories will remain visible in study flow and sensitivity analyses. The primary analysis uses one event per infant.
Data governance Identifiable records, original free text, images, and identity linkage files will remain within each center's authorized environment. Locked code will preferentially be run locally at collaborating centers. Only approved aggregate results and the minimum permitted de-identified audit information will be transferred to the coordinating center. No research-specific treatment or additional biological sampling is planned.
- Conditions
- Acute Respiratory Distress Syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of high-priority review for the high-likelihood NARDS-compatible clinical phenotype
We 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.
Measured: One assessment per first eligible respiratory event, using records from 48 hours before to 48 hours after the first screening trigger (T0).
Secondary outcomes (3)
Positive predictive value of high-priority review
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.
Measured: One assessment per first eligible respiratory event, using records from 48 hours before to 48 hours after T0.
Negative predictive value for the high-priority triage policy
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.
Measured: One assessment per first eligible respiratory event, using records from 48 hours before to 48 hours after T0.
Proportion of infants with a determinate reference-standard assessment
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.
Measured: At reference adjudication of the first eligible event, using the same records from 48 hours before to 48 hours after T0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start10 Nov 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Chongqing Medical Center for Women and Children, Northwest Women's and Children's Hospital, Xi'an, Shaanxi
- Responsible party
- Sponsor
- Investigators
- Liyuan Hu, Ph.D., Study chair, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920718
- Sponsor's protocol ID
- 2026-419A01
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Multicenter Validation of an Explainable System for Identifying Clinical Phenotypes Compatible With Neonatal Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07920718
- Acronym / sponsor ID
- 2026-419A01
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Collaborators
- Chongqing Medical Center for Women and Children, Northwest Women's and Children's Hospital, Xi'an, Shaanxi
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neonatal acute respiratory distress syndrome (NARDS) can be difficult to identify consistently because relevant information is distributed across clinical notes, imaging reports, and respiratory support records. This study will develop and validate an explainable system that organizes routinely collected electronic health record information and identifies infants whose clinical findings are compatible with NARDS.
The study will involve three neonatal intensive care units in China. Historical records from the lead center will be used for system development. A later period at the lead center and independent records from the two collaborating centers will be used for temporal and geographic validation. After the system has been locked, newly eligible infants will be included in a prospective validation phase without changing their clinical care.
System results will be compared with an independent reference assessment by neonatal intensive care specialists. The specialists will classify each infant's first eligible respiratory event as a high-likelihood NARDS-compatible clinical phenotype, a non-compatible clinical phenotype, clinically uncertain, or insufficient information. The study will evaluate sensitivity, specificity, predictive values, review workload, and the ability to identify insufficient information. During prospective validation, system results will remain unavailable to treating clinicians. The system is being evaluated as a research screening and review tool; it is not intended to replace a full clinical diagnosis or to determine treatment.
Detailed description
Study design and objective This is a three-center observational cohort study combining retrospective system development and validation with prospective validation of a locked system. Its objective is to develop an explainable electronic health record-based system for identifying a NARDS-compatible clinical phenotype and prioritizing candidate records for specialist review.
Establishment of retrospective cohorts Historical NICU records dated January 1, 2018, through December 31, 2025, will provide the retrospective source population. Records from the lead center dated 2018-2022 will form the development cohort. Records from the lead center dated 2023-2025 will form an independent internal temporal validation cohort. Records from each collaborating center dated 2023-2025 will form two separate geographic external validation cohorts. The planned formal adjudication sample is approximately 1,600 candidate events for development and 800 candidate events in each of the three retrospective validation cohorts. Each infant's first eligible event will be used in the primary analysis.
Candidate screening and sampling Candidate records will be identified using prespecified evidence of respiratory support or escalation, bilateral or diffuse pulmonary imaging abnormalities, acute lung injury triggers, or relevant diagnostic expressions. Diagnostic codes will be used for screening and descriptive analyses.
System development and locking The system will extract traceable evidence from imaging reports and other permitted clinical records, including acute respiratory deterioration, acute lung injury triggers, pulmonary imaging abnormalities, and alternative explanations. It will assign high-priority review, routine review, or insufficient-information status and retain the supporting source and timestamp. The variable dictionary, text-processing rules, feature mappings, decision rules, thresholds, software version, and analysis plan will be locked before validation. No retraining, threshold selection, or center-specific tuning will use validation labels.
Reference standard Two qualified neonatal intensive care specialists will independently assess each evidence package using a prespecified adjudication manual. Disagreement will undergo independent arbitration and, when necessary, structured consensus. Adjudicators will be masked to system outputs, explanations, discharge diagnostic labels, and diagnostic codes. They will assign one of four categories: high-likelihood NARDS-compatible clinical phenotype, non-compatible clinical phenotype, clinically uncertain, or insufficient information. The high-likelihood phenotype requires an acute respiratory course, evidence of an acute lung injury trigger, bilateral or diffuse pulmonary parenchymal imaging abnormalities, and no single alternative explanation that fully accounts for the findings.
Prospective validation After retrospective temporal and geographic validation, the same locked system will be assessed in newly eligible infants at the participating centers. The proposed prospective phase will include consecutive eligible infants and will preserve the same index-event definition, evidence window, reference standard, and output categories. Results will be generated in silent mode and will not be displayed to treating clinicians or used to guide care. Independent adjudicators will remain masked to system outputs. Prospective sample size, center participation, recruitment dates, and consent arrangements will be finalized in the protocol and ethics documentation before this phase begins.
Performance analysis The primary measure will be sensitivity of high-priority review for the reference-standard high-likelihood phenotype in each independent validation cohort. Results will be presented separately for the lead-center temporal cohort, each external center, and the prospective phase, with center-specific prospective results when sample size permits. Ninety-five percent confidence intervals will accompany performance estimates. Sampling weights will be used when estimating performance in the historical candidate population. These categories will remain visible in study flow and sensitivity analyses. The primary analysis uses one event per infant.
Data governance Identifiable records, original free text, images, and identity linkage files will remain within each center's authorized environment. Locked code will preferentially be run locally at collaborating centers. Only approved aggregate results and the minimum permitted de-identified audit information will be transferred to the coordinating center. No research-specific treatment or additional biological sampling is planned.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants in NICU at 3 participating hospitals before 44 weeks' postmenstrual age whose records meet ≥1 prespecified screening criterion for possible acute pulmonary injury. Historical candidates are sampled from prespecified center/calendar strata. The prospective phase consecutively enrolls newly eligible infants after system locking and retrospective validation. Separately identified screen-negative infants are reviewed if included in the registered screening audit. TTN, RDS, PPHN, pneumonia, and pulmonary hemorrhage are not automatic exclusions by diagnosis alone. Independent adjudication determines whether an alternative condition fully explains findings. Missing key evidence yields an uncertain/insufficient-information assessment, not automatic exclusion or a negative disease label.
Key inclusion criteria (4 listed)
- Receiving care in the NICU of a participating hospital before 44 weeks of postmenstrual age at the index event.
- Meeting at least one prespecified candidate screening criterion, including a relevant acute lung injury or NARDS/ARDS expression, respiratory support or support escalation, bilateral or diffuse pulmonary parenchymal abnormalities in an imaging report, or a prespecified acute lung injury trigger.
- Having records within the prespecified center and calendar-period cohort, or being newly eligible during the approved prospective validation period.
- Availability of an appropriate legal basis for use of the records, including parental or guardian consent or an ethics-approved waiver when applicable.
Key exclusion criteria (3 listed)
- Structural lung or airway malformations, complex congenital heart disease, or clearly established cardiac dysfunction or fluid overload that fully explains the respiratory failure and imaging abnormalities.
- Short-term postoperative mechanical ventilation without evidence of acute pulmonary injury.
- Duplicate or unresolvable records that prevent reliable identification of the infant or index event.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of high-priority review for the high-likelihood NARDS-compatible clinical phenotype
Time frame: One assessment per first eligible respiratory event, using records from 48 hours before to 48 hours after the first screening trigger (T0).
We 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.
3 secondary outcomes
Positive predictive value of high-priority review
Time frame: One assessment per first eligible respiratory event, using records from 48 hours before to 48 hours after T0.
Negative predictive value for the high-priority triage policy
Time frame: One assessment per first eligible respiratory event, using records from 48 hours before to 48 hours after T0.
Proportion of infants with a determinate reference-standard assessment
Time frame: At reference adjudication of the first eligible event, using the same records from 48 hours before to 48 hours after T0.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liyuan Hu, Ph.D. study chair
Guangzhou Women and Children's Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by Guangzhou Women and Children's Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liyuan Hu, Ph.D. (+86-13816060888, nowadays921@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of high-priority review for the high-likelihood NARDS-compatible clinical phenotype (time frame: One assessment per first eligible respiratory event, using records from 48 hours before to 48 hours after the first screening trigger (T0).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.