Assessing Clinical Improvement of Infants Hospitalized for Respiratory Syncytial Virus–Related Critical Illness - Report - MDSpire
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Evaluating Clinical Outcomes in Infants Admitted for Severe Respiratory Syncytial Virus Infections

  • By

  • Shannon B Leland

  • Laura D Zambrano

  • Steven J Staffa

  • Elizabeth R McNamara

  • Margaret M Newhams

  • Natasha Halasa

  • Justin Z Amarin

  • Laura S Stewart

  • Steven L Shein

  • Christopher L Carroll

  • Julie C Fitzgerald

  • Marian G Michaels

  • Katherine Bline

  • Melissa L Cullimore

  • Laura Loftis

  • Vicki L Montgomery

  • Asumthia S Jeyapalan

  • Pia S Pannaraj

  • Adam J Schwarz

  • Natalie Z Cvijanovich

  • Matt S Zinter

  • Aline B Maddux

  • Melania M Bembea

  • Katherine Irby

  • Danielle M Zerr

  • Joseph D Kuebler

  • Christopher J Babbitt

  • Mary G Gaspers

  • Ryan Nofziger

  • Michele Kong

  • Bria M Coates

  • Jennifer E Schuster

  • Shira J Gertz

  • Elizabeth H Mack

  • Benjamin R White

  • Helen Harvey

  • Charlotte V Hobbs

  • Heda Dapul

  • Andrew D Butler

  • Tamara T Bradford

  • Courtney M Rowan

  • Kari Wellnitz

  • Mary Allen Staat

  • Cassyanne L Aguiar

  • Saul R Hymes

  • Angela P Campbell

  • Adrienne G Randolph

  • Respiratory Syncytial Virus - Pediatric Intensive Care (RSV-PIC) Investigators

  • Merry Tomcany

  • Kelly N Michelson

  • Heather E Price

  • Ronald C Sanders

  • Lexie Dixon

  • Katri V Typpo

  • Ilana Harwayne-Gidansky

  • Suden Kucukak

  • SabrinaR Chen

  • Eve Listerud

  • Ofelia Vargas-Shiraishi

  • Betty Oberle

  • Frances Zorensky

  • Rachel Mansour

  • Jaycee Jumarang

  • Marla Johnston

  • Jenny L Bush

  • Shawn Dickey

  • Shannon Hill

  • Melissa Sullivan

  • Abigail Kietzman

  • Candice Colston

  • Meghan Murdock

  • Heather Kelley

  • Laura Wright-Sexton

  • Maygan Martin

  • Lora Martin

  • Lacy Malloch

  • Kayla Patterson

  • Cameron Sanders

  • Chelsea Rohlfs

  • Marilyn Rice

  • Miranda Howard

  • Makayla Murphy

  • Vijaya L Soma

  • Adam J Ratner

  • Megan J Job

  • Colleen Mennie

  • Kamala Simkhada

  • Kristina A Betters

  • Haya Hayek

  • Molly Maranto

  • Aubrie Waters

  • Maggie Flowers

  • Kevin Havlin

  • Jamie Furlong-Dillard

  • Melissa Porter

  • Jennifer Nason

  • Madison Ray

  • Kristen Gossett

  • Hillary Crandall

  • Evan Heller

  • Jennifer Foley

  • Rajashri Rasal

  • Christine Marlow

  • Anurithi Senthil

  • Kimberly Myers

  • Betsy Tudor

  • Amanda Adler

  • Nereyda Garcia

  • Natalie Treister

  • Patrick S McQuillen

  • Kathleen Sun

  • Denise Villarreal-Chico

  • Sophia Kainaroi

  • John V Williams

  • January 15, 2025

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Clinical Report: Outcomes in Infants Hospitalized for Severe RSV Infection

Overview

In a prospective study of 585 infants hospitalized with severe RSV-related respiratory illness, 35% failed to show clinical improvement by day 7. Key predictors of poor improvement included age under 3 months, prematurity, underlying respiratory conditions, and early invasive mechanical ventilation (IMV). The Clinical Progression Scale–Pediatrics (CPS-Ped) was validated as a sensitive measure of disease severity and clinical improvement.

Background

Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory tract infections in infants, frequently necessitating hospitalization and intensive care. Despite advances in preventive measures, no therapies have proven to alter RSV disease progression. Traditional outcome measures like mortality and ventilator-free days are limited due to low mortality and IMV rates. The CPS-Ped scale offers a comprehensive tool to assess respiratory support needs and hypoxia severity, potentially improving clinical trial endpoints and surveillance.

Data Highlights

ParameterValue
Total infants hospitalized585
Infants receiving invasive mechanical ventilation (IMV)138 (23.6%)
Mortality1 infant
Failure to clinically improve by day 7205 (35%)
Sample size per arm to detect 15% improvement using CPS-Ped584
Sample size per arm to detect 15% improvement using hospital length of stay2031

Key Findings

  • 35% of infants hospitalized with severe RSV did not show clinical improvement by day 7 as measured by CPS-Ped.
  • Age under 3 months, prematurity, underlying respiratory conditions, and early IMV were significant predictors of failure to improve.
  • The CPS-Ped scale effectively captured a spectrum of respiratory disease severity and tracked clinical progression over time.
  • Mortality was very low (1 death), highlighting the challenge of using mortality as a clinical trial endpoint in this population.
  • Sample size estimates indicate CPS-Ped requires fewer patients than hospital length of stay to detect meaningful clinical improvement in trials.

Clinical Implications

The CPS-Ped scale provides a sensitive and practical outcome measure for assessing disease severity and clinical improvement in infants with severe RSV infection. Its use could facilitate more efficient clinical trials by reducing required sample sizes compared to traditional endpoints. Clinicians should recognize that younger age, prematurity, and early need for invasive ventilation identify infants at higher risk for prolonged illness.

Conclusion

CPS-Ped is a valuable tool for monitoring clinical progression and evaluating therapeutic interventions in infants hospitalized with severe RSV. Its application may improve clinical trial design and public health surveillance by capturing nuanced respiratory disease severity.

References

  1. Clinical Progression Scale–Pediatrics Study, 2023 -- Evaluating Clinical Outcomes in Infants Admitted for Severe Respiratory Syncytial Virus Infections

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