An observational study in Acute Respiratory Distress Syndrome, sponsored by Guangzhou Women and Children's Medical Center. Not yet recruiting. Open to participants aged Up to 30 Days. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Guangzhou Women and Children's Medical Center · Observational
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.
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.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's planned enrollment of 1,600 is above the median of 100 across 475 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Guangzhou Women and Children's Medical Center is the lead sponsor of 58 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Sensitivity of high-priority review for the high-likelihood NARDS-compatible clinical phenotype
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.
Time frame: One assessment per first eligible respiratory event, using records from 48 hours before to 48 hours after the first screening trigger (T0).
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.
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
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.
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
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.
Time frame: At reference adjudication of the first eligible event, using the same records from 48 hours before to 48 hours after T0.
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Dec 2028, 24 months later.
Of 225 non-industry observational studies under Respiratory Distress Syndrome, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 24 months is close to that.
Counting every sponsor, half of 231 studies reached it within 24 months; a quarter within 12 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome →
Guangzhou Women and Children's Medical Center