Assessing Clinical Improvement of Infants Hospitalized for Respiratory Syncytial Virus-Related Critical Illness.
Summary
In a 39-PICU prospective registry (n=585) of infants with RSV critical illness, CPS-Ped sensitively tracked severity and improvement and identified risk factors for non-improvement by day 7. Power calculations showed CPS-Ped-based endpoints require far fewer participants than length of stay to detect a 15% improvement.
Key Findings
- Among 585 infants, 23.6% required invasive mechanical ventilation and 8.4% worsened by ≥2 CPS-Ped points; one death occurred.
- Failure to improve by day 7 (35%) was independently associated with age <3 months, prematurity, underlying respiratory disease, and IMV within 24 hours.
- Detecting a 15% improvement requires far fewer participants using CPS-Ped (n=584 per arm) than length of stay (n=2,031 per arm).
Clinical Implications
Use CPS-Ped to monitor severity and define trial endpoints in infants with RSV critical illness; early identification of high-risk infants (age <3 months, prematurity, baseline respiratory disease, early IMV) can inform stratification and management.
Why It Matters
Establishes CPS-Ped as a responsive pediatric respiratory endpoint and provides concrete sample size advantages, enabling more feasible interventional RSV trials.
Limitations
- Observational design cannot infer causality or treatment effects.
- Generalizability is limited to infants with RSV-related critical illness.
Future Directions
Validate CPS-Ped responsiveness across broader pediatric respiratory diseases and embed CPS-Ped as a primary endpoint in interventional RSV trials.
Study Information
- Study Type
- Cohort
- Research Domain
- Prognosis
- Evidence Level
- II - Prospective multicenter cohort analyzing severity trajectories and predictors.
- Study Design
- OTHER