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Pediatric Cardiology Feb 2024To improve palivizumab administration in high-risk infants with congenital heart disease to 80% over 2 years at an academic children's heart center. A multidisciplinary...
To improve palivizumab administration in high-risk infants with congenital heart disease to 80% over 2 years at an academic children's heart center. A multidisciplinary team at our institution implemented a series of interventions over a 2-year prior. Pediatric cardiac patients were identified for palivizumab eligibility, and a baseline rate of administration was obtained. A series of communication and documentation-based interventions were implemented over the course of the next 2 years. Palivizumab eligible infants (n = 114) were determined based on guidelines after review of diagnosis code, oxygen saturation, and medications. Doses of palivizumab were tracked via the electronic health record. The primary outcome measures were the rate of monthly palivizumab doses administered per the number of eligible months and the percentage of infants who received at least 80% of eligible doses during the respiratory syncytial virus season. The rate of monthly palivizumab doses increased from 57.6% during the baseline period to 78.4% during the final year of the project (p = 0.02). The percentage of infants who received 80% of eligible doses increased from 42.1 to 60% but was not statistically significant (p = 0.20). Interventions focused on properly identifying and tracking infants eligible for palivizumab treatment significantly increased the rates of administration.
PubMed: 38300318
DOI: 10.1007/s00246-023-03388-3 -
American Journal of Perinatology Oct 2023In 2014, the American Academy of Pediatrics (AAP) changed its policy on the use of respiratory syncytial virus immunoprophylaxis (RSV-IP) so that RSV-IP was no longer... (Observational Study)
Observational Study
OBJECTIVE
In 2014, the American Academy of Pediatrics (AAP) changed its policy on the use of respiratory syncytial virus immunoprophylaxis (RSV-IP) so that RSV-IP was no longer recommended for use among infants without other medical conditions born >29 weeks of gestational age (wGA). This study examines 10-year trends in RSV-IP and RSV hospitalizations among term infants and preterm infants born at 29 to 34 wGA, including the 5 RSV seasons before and 5 RSV seasons after the AAP guidance change.
STUDY DESIGN
A retrospective observational cohort study of a convenience sample of infants less than 6 months of age during RSV season (November-March) born between July 1, 2008, and June 30, 2019, who were born at 29 to 34 wGA (preterm) or >37 wGA (term) in the IBM MarketScan Commercial and Multi-State Medicaid databases. We excluded infants with medical conditions that would independently qualify them for RSV-IP. We identified RSV-IP utilization along with RSV and all-cause bronchiolitis hospitalizations during each RSV season. A difference-in-difference model was used to determine if there was a significant change in the relative rate of RSV hospitalizations following the 2014 policy change.
RESULTS
There were 53,535 commercially insured and 85,099 Medicaid-insured qualifying preterm infants and 1,111,670 commercially insured and 1,492,943 Medicaid-insured qualifying term infants. Following the 2014 policy change, RSV-IP utilization decreased for all infants, while hospitalization rates tended to increase for preterm infants. Rate ratios comparing preterm to term infants also increased. The relative rate for RSV hospitalization for infants born at 29 to 34 wGA increased significantly for both commercially and Medicaid-insured infants (1.95, 95% CI: 1.67-2.27, <0.001; 1.70, 95% CI: 1.55-1.86, <0.001, respectively). Findings were similar for all-cause bronchiolitis hospitalizations.
CONCLUSION
We found that the previously identified increase in RSV hospitalization rates among infants born at 29 to 34 wGA persisted for at least 5 years following the policy change.
KEY POINTS
· Immunoprophylaxis rates decreased after the 2014 American Academy of Pediatrics guidelines update.. · Rate of RSV hospitalization increased among preterm infants after the 2014 AAP guidelines update.. · Increase in RSV hospitalization persisted for at least 5 years after AAP guidelines update..
Topics: Infant; Female; Infant, Newborn; Humans; Child; United States; Infant, Premature; Respiratory Syncytial Virus Infections; Antiviral Agents; Retrospective Studies; Hospitalization; Gestational Age; Respiratory Syncytial Virus, Human; Bronchiolitis; Palivizumab
PubMed: 34704241
DOI: 10.1055/s-0041-1736581 -
American Journal of Obstetrics and... Feb 2024Respiratory syncytial virus is a leading cause of lower respiratory tract illness globally in children aged <5 years. Each year, approximately 58,000 hospitalizations in...
Respiratory syncytial virus is a leading cause of lower respiratory tract illness globally in children aged <5 years. Each year, approximately 58,000 hospitalizations in the United States are attributed to respiratory syncytial virus. Infants aged ≤6 months experience the most severe morbidity and mortality. Until recently, prevention with the monoclonal antibody, palivizumab, was only offered to infants with high-risk conditions, and treatment primarily consisted of supportive care. Currently, 2 products are approved for the prevention of respiratory syncytial virus in infants. These include the Pfizer bivalent recombinant respiratory syncytial virus prefusion F protein subunit vaccine, administered seasonally to the pregnant person between 32 0/7 and 36 6/7 weeks of gestation, and the monoclonal antibody, nirsevimab, administered to infants aged up to 8 months entering their first respiratory syncytial virus season. With few exceptions, administering both the vaccine to the pregnant person and the monoclonal antibody to the infant is not recommended. All infants should be protected against respiratory syncytial virus using one of these strategies. Key considerations for pregnant individuals include examining available safety and efficacy data, weighing accessibility and availability, and patient preferences for maternal vaccination vs infant monoclonal antibody treatment. It will be critical for maternal-fetal medicine physicians to provide effective and balanced counseling to aid patients in deciding on a personalized approach to the prevention of respiratory syncytial virus in their infants.
Topics: Infant; Child; Pregnancy; Female; Humans; Perinatology; Respiratory Syncytial Virus Infections; Palivizumab; Respiratory Syncytial Viruses; Antibodies, Monoclonal; Antiviral Agents
PubMed: 37914061
DOI: 10.1016/j.ajog.2023.10.046 -
Paediatric Drugs Mar 2024Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection (LRTI) in children, and is associated with long-term pulmonary sequelae...
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection (LRTI) in children, and is associated with long-term pulmonary sequelae for up to 30 years after infection. The mainstay of RSV management is supportive therapy such as supplemental oxygen. Palivizumab (Synagis™-AstraZeneca), a monoclonal antibody targeting the RSV F protein site II, has been licensed for the prevention of RSV in high-risk groups since 1998. There has been recent promising progress in preventative strategies that include vaccines and long-acting, high-potency monoclonal antibodies. Nirsevimab (Beyfortus™-AstraZeneca/Sanofi), a monoclonal antibody with an extended half-life, has recently been registered in the European Union and granted licensure by the US Food and Drug Administration. Furthermore, a pre-fusion sub-unit protein vaccine has been granted licensure for pregnant women, aimed at protecting their young infants, following established safety and efficacy in clinical trials (Abrysvo™-Pfizer). Also, multiple novel antiviral therapeutic options are in early phase clinical trials. The next few years have the potential to change the landscape of LRTI through improvements in the prevention and management of RSV LRTI. Here, we discuss these new approaches, current research, and clinical trials in novel therapeutics, monoclonal antibodies, and vaccines against RSV infection in infants and children.
Topics: Pregnancy; United States; Child; Infant; Female; Humans; Respiratory Syncytial Virus Infections; Palivizumab; Antibodies, Monoclonal; European Union; Vaccines
PubMed: 38032456
DOI: 10.1007/s40272-023-00606-6 -
Human Vaccines & Immunotherapeutics Aug 2023Palivizumab has been shown to decrease RSV-related hospitalization (RSVH) risk and reduce RSVH severity. American Academy of Pediatrics (AAP) guidance on administration...
Palivizumab has been shown to decrease RSV-related hospitalization (RSVH) risk and reduce RSVH severity. American Academy of Pediatrics (AAP) guidance on administration of palivizumab has changed over time; in 2014, palivizumab was no longer recommended in preterm infants born at 29 weeks gestational age (wGA) or later. This study's objective was to describe RSVH risk and severity in preterm infants (29-34 wGA) without comorbidities relative to healthy term infants and to each other by gestational age. Using the MarketScan Multi-State Medicaid and Commercial Databases, infants born from July 1, 2014 to June 30, 2019, at 29-34 wGA (preterm) and >37 wGA (term) were identified. During RSV seasons (November to March) from 2014 to 2020, claims incurred by infants while they were <6 months old were evaluated for RSVH and RSVH characteristics. This study included 63,351 preterm infants and 1,076,389 term infants without outpatient palivizumab administration. Rate of RSVH was higher in infants with lower wGA at birth and ranged 3.32-5.72 per 100 infant-seasons in Medicaid-insured infants and 3.21-4.84 in commercially insured infants. Relative risk of RSVH was 5-8 times higher in Medicaid-insured preterm infants and 3-5 times higher in commercially insured preterm infants compared to term infants. ICU admissions and mechanical ventilation were more common during RSVH in preterm infants relative to term infants. RSV-related outpatient healthcare utilization was also 2-3 times higher in preterm infants born at 31-34 wGA. Increased utilization of palivizumab among infants born at 29-34 wGA may decrease RSVH rates and result in less severe course in preterm infants with RSVH.
Topics: Infant; Infant, Newborn; Humans; Child; United States; Palivizumab; Gestational Age; Infant, Premature; Antiviral Agents; Outpatients; Respiratory Syncytial Virus Infections; Hospitalization
PubMed: 37828711
DOI: 10.1080/21645515.2023.2252289 -
Journal of the Association of Medical... Nov 2023The introduction of nirsevimab (a respiratory syncytial virus [RSV] monoclonal antibody that can protect for minimum 5 months with a single dose) and RSV maternal...
The introduction of nirsevimab (a respiratory syncytial virus [RSV] monoclonal antibody that can protect for minimum 5 months with a single dose) and RSV maternal vaccines to protect young infants has the potential to dramatically decrease RSV hospitalizations in Canada. However, there remain many unanswered questions before optimal use of these products can be assured.
PubMed: 38058503
DOI: 10.3138/jammi-2023-05-31 -
Italian Journal of Pediatrics Mar 2024Respiratory Syncytial Virus (RSV) infections may lead to severe consequences in infants born preterm with breathing problems (such as bronchopulmonary dysplasia (BPD)...
BACKGROUND
Respiratory Syncytial Virus (RSV) infections may lead to severe consequences in infants born preterm with breathing problems (such as bronchopulmonary dysplasia (BPD) and respiratory distress syndrome (RDS)) or congenital heart diseases (CHD). Since studies investigating the influence of different gestational age (WGA) and concomitant specific comorbidities on the burden of RSV infections are scarce, the present study aimed to better characterize these high-risk populations in the Italian context.
METHODS
This retrospective, longitudinal and record-linkage cohort study involved infants born between 2017 and 2019 in Lazio Region (Italy) and is based on data extracted from administrative databases. Each infant was exclusively included in one of the following cohorts: (1) BPD-RDS (WGA ≤35 with or without CHD) or (2) CHD (without BPD and/or RDS) or (3) Preterm (WGA ≤35 without BPD (and/or RDS) or CHD). Each cohort was followed for 12 months from birth. Information related to sociodemographic at birth, and RSV and Undetermined Respiratory Agents (URA) hospitalizations and drug consumption at follow-up were retrieved and described.
RESULTS
A total of 8,196 infants were selected and classified as 1,084 BPD-RDS, 3,286 CHD and 3,826 Preterm. More than 30% of the BPD-RDS cohort was composed by early preterm infants (WGA ≤ 29) in contrast to the Preterm cohort predominantly constitute by moderate preterm infants (98.2%), while CHD infants were primarily born at term (83.9%). At follow-up, despite the cohorts showed similar proportions of RSV hospitalizations, in BPD-RDS cohort hospitalizations were more frequently severe compared to those occurred in the Preterm cohort (p<0.01), in the BPD-RDS cohort was also found the highest proportion of URA hospitalizations (p<0.0001). In addition, BPD-RDS infants, compared to those of the remaining cohorts, received more frequently prophylaxis with palivizumab (p<0.0001) and were more frequently treated with adrenergics inhalants, and glucocorticoids for systemic use.
CONCLUSIONS
The assessment of the study clinical outcomes highlighted that, the demographic and clinical characteristics at birth of the study cohorts influence their level of vulnerability to RSV and URA infections. As such, continuous monitoring of these populations is necessary in order to ensure a timely organization of health care system able to respond to their needs in the future.
Topics: Infant; Infant, Newborn; Humans; Respiratory Syncytial Virus Infections; Infant, Premature; Retrospective Studies; Cohort Studies; Palivizumab; Hospitalization; Heart Defects, Congenital; Bronchopulmonary Dysplasia; Antiviral Agents
PubMed: 38528568
DOI: 10.1186/s13052-024-01627-8 -
Neonatal Network : NN Aug 2023Respiratory syncytial virus (RSV) is a leading cause of morbidity and hospitalization in young children, and prevention is the primary management strategy. At present,...
Understanding Policy Decisions and Their Implications Regarding Preventive Interventions for Respiratory Syncytial Virus (RSV) Infection in Canadian Infants: A Primer for Nurses.
Respiratory syncytial virus (RSV) is a leading cause of morbidity and hospitalization in young children, and prevention is the primary management strategy. At present, palivizumab, a monoclonal antibody providing immediate passive immunity, rather than a vaccine that induces active immunity, is the only preventive intervention used in routine practice internationally. In Canada, access varies across the country. Prophylaxis policies are mainly driven by cost-effectiveness analyses, and it is crucial that the full costs and benefits of any intervention are captured. Positive results from a new Canadian cost-effectiveness analysis of palivizumab will help address the current inequality in use while providing a framework for future models of RSV preventives. Nurses are the principal educators for parents about the risks of childhood RSV and optimal prevention basic hygiene, behavioral and environmental measures, and seasonal prophylaxis. Nurses should be provided not only with regular, up-to-date, and accurate information on RSV and the clinical aspects of emerging interventions but be informed on the decision-making governing the use of preventive strategies.
PubMed: 37657806
DOI: 10.1891/NN-2023-0005 -
Journal of the Pediatric Infectious... Sep 2023Severe respiratory syncytial virus (RSV) infections disparately impact American Indian communities. We implemented a program that expanded palivizumab to all children...
Severe respiratory syncytial virus (RSV) infections disparately impact American Indian communities. We implemented a program that expanded palivizumab to all children under 2 years of age that led to significant reductions in RSV infections and hospitalizations for both high-risk and non-high-risk recipients in a rural American Indian community in Eastern Arizona.
PubMed: 37671822
DOI: 10.1093/jpids/piad063 -
American Journal of Perinatology May 2024Our objective was to compare rates of hospitalizations for respiratory illnesses in preterm and full-term (FT) children for 4 years before and after the 2014 update...
OBJECTIVES
Our objective was to compare rates of hospitalizations for respiratory illnesses in preterm and full-term (FT) children for 4 years before and after the 2014 update to the American Academy of Pediatrics (AAP) respiratory syncytial virus (RSV) immunoprophylaxis guidance, which restricted eligibility among infants born at 29 to 34 weeks in the first winter and all preterm infants in the second winter after neonatal discharge.
STUDY DESIGN
We conducted pre-post and interrupted time series analyses on claims data from a commercial national managed care plan. We compared the number of RSV and all respiratory hospital admissions in the first and second RSV seasons after neonatal discharge among a cohort of preterm children, regardless of palivizumab status, in the 4 years before and after the implementation of the 2014 palivizumab eligibility change. A FT group was included for reference.
RESULTS
The cohort included 821 early preterm (EP, <29 weeks), 4,790 moderate preterm (MP, 29-34 weeks), and 130,782 FT children. Palivizumab use after the policy update decreased among MP children in the first and second RSV seasons after neonatal discharge, without any change in the odds of hospitalization with RSV or respiratory illness. For the EP group, there was no change in the rate of palivizumab or the odds of hospitalization with RSV or respiratory illness after the policy update. For the FT group, there was a slight decrease in odds of hospitalization post-2014 after the policy update. The interrupted time series did not reveal any secular trends over time in hospitalization rates among preterm children. Following the policy change, there were cost savings for MP children in the first and second RSV seasons, when accounting for the cost of hospitalizations and the cost of palivizumab.
CONCLUSION
Hospitalizations for RSV or respiratory illness did not increase, and cost savings were obtained after the implementation of the 2014 AAP palivizumab prophylaxis policy.
KEY POINTS
· Palivizumab use decreased among children born moderate preterm (29 to34 weeks) after the 2014 palivizuamb policy update.. · There was no change in odds of hospitalization with respiratory syncitial virus or respiratory illness among preterm infants after the policy update when compared to before.. · There were cost savings, when accounting for the cost of hospitalizations and the cost of palivizumab, after the policy update among children born moderate preterm..
Topics: Humans; Palivizumab; Respiratory Syncytial Virus Infections; Hospitalization; Infant, Premature; Antiviral Agents; Infant, Newborn; Male; Female; Interrupted Time Series Analysis; Cost Savings; Infant; United States; Health Policy; Respiratory Tract Infections; Seasons; Gestational Age
PubMed: 35523410
DOI: 10.1055/a-1845-2184