Why match? Investigating matched case-control study designs with causal effect estimation.
Sherri Rose, Mark J van der Laan
https://pubmed.ncbi.nlm.nih.gov/20231866Actively Recruiting
Age: 0 - 4Years
All Genders
ID06511687
Effectiveness And Impact of Nirsevimab In A Nationwide Immunization Program During The 2024 Winter Campaign In Chile (Nirse-CL)
Led by Instituto Sistemas Complejos de Ingeniería · Updated on 2024-07-22
160000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of the monoclonal antibody nirsevimab in preventing Respiratory Syncytial Virus (RSV) infection in infants during the 2024 RSV season in Chile. This observational study also aims to assess the impact of a nationwide immunization program on RSV-related health outcomes by analyzing several national databases before, during, and after program implementation. Nirsevimab will be given as a single dose to eligible infants, including those born during the autumn-winter season of 2024, infants aged 1 to 6 months at immunization time, and high-risk infants defined by gestational age, birth weight, or bronchopulmonary dysplasia status. The immunization is part of Chile's national program, with expected high coverage rates. Different groups include newborns, catch-up infants, and high-risk cohorts. Participants' health outcomes will be monitored through hospitalization records for lower-tract respiratory infections attributed to RSV, especially in pediatric intensive care units, at national and regional levels from April to October 2024. Researchers will use statistical models to compare hospitalizations between immunized and non-immunized infants, considering factors like gestational age, birth weight, sex, and other health indicators. This comprehensive analysis aims to provide robust evidence of nirsevimab's impact on RSV-related hospitalizations.
CONDITIONS
Brief Title
Effectiveness And Impact Of Nirsevimab In Chile (NIRSE-CL)
Who Can Participate
Age: 0 - 4Years
All Genders
Eligibility Criteria
You may qualify if you...
- Subjects born between October 1st, 2023, to September 31st, 2024.
- Subjects born with 29 weeks of gestational age or less who were born between July 1st, 2023 and October 1st, 2023.
- Subjects born with Bronchopulmonary Dysplasia (BPD), 32 weeks gestational age or less and/or a birth weight less than 1.75 kgs born between April 1st, 2023 and October 1st, 2023.
You will not qualify if you...
- No specific criteria has been reported.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Approximately 6 months before immunization starting April 2024
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or medical record review)
Implementation
Duration - April 2024 to June 2024
Participants receive a single dose of nirsevimab as part of Chile's national immunization program at birth or at the beginning of the winter campaign.
1 visit for immunization
Long-term Monitoring
Duration - April 2024 to October 2024
Participants are observed for respiratory health outcomes including hospitalizations due to lower-tract respiratory infections attributed to RSV during the RSV season.
Ongoing monitoring through medical records, no additional visits required
Trial Site Locations
Total: 1 location
1
ISCI
Santiago, Chile, 8370398
Actively Recruiting
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Research Team
L
Leonardo Basso, PhD in Business Administration
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Christian A W Bruhn, Stephen Hetterich, Cynthia Schuck-Paim...
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Neil Pearce
https://pubmed.ncbi.nlm.nih.gov/26916049Effectiveness and impact of nirsevimab in Chile during the first season of a national immunisation strategy against RSV (NIRSE-CL): a retrospective observational study.
Juan Pablo Torres, Denis Sauré, Marcel Goic...
https://pubmed.ncbi.nlm.nih.gov/40513593