Related Experiment Video
Updated: Jun 2, 2025
An Improved and High Throughput Respiratory Syncytial Virus RSV Micro-neutralization Assay
Published on: January 26, 2019
Assessing Clinical Improvement of Infants Hospitalized for Respiratory Syncytial Virus-Related Critical Illness
Shannon B Leland1,2, Laura D Zambrano3, Steven J Staffa1
1Department of Anesthesiology, Critical Care, and Pain Medicine, Boston Children's Hospital, Boston, Massachusetts.
Insights
The Clinical Progression Scale Pediatrics (CPS-Ped) effectively tracks disease severity in infants hospitalized with severe respiratory syncytial virus (RSV) lower respiratory tract infections. This scale requires a smaller sample size for clinical trials compared to hospital length of stay.
Area of Science:
- Pediatric critical care medicine
- Infectious diseases
- Clinical trial methodology
Background:
- Pediatric acute lower respiratory tract infection (LRTI) due to respiratory syncytial virus (RSV) frequently necessitates hospitalization.
- The Clinical Progression Scale Pediatrics (CPS-Ped) assesses respiratory support and hypoxia but hasn't been used for severe RSV-LRTI in infants.
- Evaluating novel therapeutics for severe RSV in infants requires robust clinical outcome measures.
Purpose of the Study:
- To evaluate the utility of the CPS-Ped in infants hospitalized with severe RSV-LRTI.
- To identify predictors of clinical improvement by day 7 using CPS-Ped.
- To compare the sample size required for detecting therapeutic effects using CPS-Ped versus hospital length of stay (LOS).
Main Methods:
- Prospective surveillance of 585 infants hospitalized with RSV complications across 39 U.S. PICUs (October-December 2022).
- CPS-Ped scores assigned at admission and on days 2-7, 10, and 14.
- Multivariable log-binomial regression identified predictors of clinical improvement (CPS-Ped ≤2 or 3-point decrease by day 7); sample size estimation performed.
Main Results:
- Failure to improve by day 7 occurred in 35% of infants, associated with younger age, prematurity, underlying respiratory conditions, and early invasive mechanical ventilation (IMV).
- CPS-Ped score worsened in 8.4% of infants, with one death.
- Detecting a 15% clinical improvement required an estimated 584 participants per arm using CPS-Ped versus 2,031 using hospital LOS.
Conclusions:
- The CPS-Ped effectively captures disease severity and tracks clinical improvement in critically ill infants with RSV.
- CPS-Ped is a valuable tool for assessing therapeutic interventions in pediatric RSV.
- Utilizing CPS-Ped in clinical trials can significantly reduce required sample sizes compared to hospital LOS.
Background:
Pediatric respiratory syncytial virus (RSV)-related acute lower respiratory tract infection (LRTI) commonly requires hospitalization. The Clinical Progression Scale-Pediatrics (CPS-Ped) measures level of respiratory support and degree of hypoxia across a range of disease severity, but it has not been applied in infants hospitalized with severe RSV-LRTI.
Methods:
We analyzed data from a prospective surveillance registry of infants hospitalized for RSV-related complications across 39 pediatric intensive care units in the United States from October through December 2022. We assigned CPS-Ped (0 = discharged home at respiratory baseline to 8 = death) at admission and days 2-7, 10, and 14. We identified predictors of clinical improvement (CPS-Ped ≤2 or 3-point decrease) by day 7 using multivariable log-binomial regression models and estimated the sample size (80% power) to detect 15% between-group clinical improvement with CPS-Ped versus hospital length of stay (LOS).
Results:
Of 585 hospitalized infants, 138 (23.6%) received invasive mechanical ventilation (IMV) and 1 died. Failure to clinically improve by day 7 occurred in 205 (35%) infants and was associated with age <3 months, prematurity, underlying respiratory condition, and IMV in the first 24 hours in the multivariable analysis. The estimated sample size per arm required for detecting a 15% clinical improvement in a potential study was 584 using CPS-Ped clinical improvement versus 2031 for hospital LOS.
Conclusions:
CPS-Ped can be used to capture a range of disease severity and track clinical improvement in infants who develop RSV-related critical illness and could be useful for evaluating therapeutic interventions for RSV.
More Related Videos
Related Concept Videos
01:29Acute Respiratory Failure-V
Ensure that patients are monitored continuously for their response to therapy, including changes in...
01:28Pneumonia IV: Management
Bacterial Pneumonia Treatment
For bacterial pneumonia, antibiotics serve as the cornerstone of therapy. Initial treatment often begins with empirical antibiotics, tailored to the anticipated causative organism and adjusted based on culture results. Key antibiotic choices include:
01:17Pulmonary Cycle: Exhalation
01:19Respiratory Assessment: Purpose and Indications
Objectives and Importance:
The primary goal of respiratory assessment is to evaluate patients at early risk of clinical deterioration. Since respiratory distress often precedes other signs of declining health, breathing patterns and sounds become a...
01:30Pneumonia III: Complications and Assessment
01:30Pneumonia V: Nursing management and Prevention
The nurse must practice strict medical asepsis and adhere to infection control guidelines to minimize healthcare-associated infections.
Enhance airway patency
Position the patient correctly to facilitate drainage of the affected lung segments. Manual or mechanical percussion and vibration can also be employed....