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Updated: Aug 20, 2025
An Improved and High Throughput Respiratory Syncytial Virus RSV Micro-neutralization Assay
Published on: January 26, 2019
RSV-related hospitalization and outpatient palivizumab use in very preterm (born at <29 wGA) infants: 2003-2020
Elizabeth R Packnett1, Isabelle H Winer1, Heather Larkin1
1Real World Data Research & Analytics, Merative, Cambridge, MA, USA.
Insights
Very preterm infants face significantly higher risks of respiratory syncytial virus hospitalization. Palivizumab, an RSV immunoprophylaxis, reduced severe outcomes in these vulnerable infants.
Area of Science:
- Pediatrics
- Infectious Diseases
- Public Health
Background:
- Respiratory syncytial virus (RSV) is a major cause of infant hospitalization, particularly for bronchiolitis and pneumonia.
- Palivizumab is an FDA-approved immunoprophylaxis for preventing severe RSV disease in high-risk infants, including those born prematurely.
- Understanding RSV hospitalization risks in very preterm infants compared to term infants is crucial for targeted prevention strategies.
Purpose of the Study:
- To compare the incidence and characteristics of RSV-related hospitalizations (RSVH) between very preterm (<29 weeks gestational age) and term (>37 weeks gestational age) infants.
- To evaluate the impact of palivizumab administration on RSVH outcomes in very preterm infants.
Main Methods:
- Retrospective analysis of administrative claims data (MarketScan Commercial and Multi-State Medicaid) from 2003-2020.
- Inclusion of infants born between July 2003 and June 2020, excluding those with specific pre-existing health conditions.
- Evaluation of RSVH and palivizumab administration in infants under 12 months during RSV seasons (November-March).
Main Results:
- The study included 40,123 very preterm and 4,421,942 term infants.
- RSVH rates were higher in very preterm infants (1.5-8.4 per 100 infant-seasons) compared to term infants, inversely related to gestational age.
- Very preterm infants had a 3-4 times higher relative risk of RSVH, with increased ICU admissions and mechanical ventilation; however, palivizumab use was associated with less severe outcomes.
Conclusions:
- Very preterm infants exhibit a substantially elevated risk for RSV hospitalization and associated severe outcomes compared to term infants.
- Outpatient palivizumab administration demonstrates a protective effect, mitigating the severity of RSVH in very preterm infants despite their higher baseline risk.
- These findings underscore the importance of RSV immunoprophylaxis for very preterm infants to reduce disease burden.
Abstract:
Respiratory syncytial virus (RSV) is a leading cause of bronchiolitis and pneumonia in children under one year and a leading cause of infant hospitalization. Palivizumab was approved by the FDA in 1998 as RSV immunoprophylaxis to prevent severe RSV disease in children with specific health conditions and those born at <35 weeks gestational age (wGA). This study compared RSV-related hospitalization (RSVH) and RSVH characteristics in very preterm (<29 wGA) and term (>37 wGA) infants. Using the MarketScan Commercial and Multi-State Medicaid administrative claims databases, infants born between 7/1/2003 and 6/30/2020 were identified and classified as very preterm or term. Infants with evidence of health conditions, such as congenital heart disease and cystic fibrosis, were excluded. During 2003-2020 RSV seasons (November to March), claims incurred by infants while they were <12 months old were evaluated for outpatient administration of palivizumab and RSVH. The study included 40,123 very preterm infants and 4,421,942 term infants. Rate of RSVH in very preterm infants ranged 1.5-3.8 per 100 infant-seasons in commercially insured infants and 3.5-8.4 in Medicaid insured infants and were inversely related to wGA at birth. Relative risk of RSVH in very preterm was 3-4 times higher, and ICU admissions and mechanical ventilation were more common during RSVH in very preterm infants relative to term infants. However, these outcomes were less common or less severe in very preterm infants who received outpatient palivizumab administration, despite evidence of higher baseline risk of RSVH in these infants.
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