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Preparing for RSV Immunisation and Surveillance in Europe: Biomarker Infant study

Preparing for RSV Immunisation and Surveillance in Europe: Biomarker Infant study - PROMISE study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON52142
Enrollment
200
Registered
2021-09-16
Start date
2021-11-05
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus RSV RS-virus

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: • Parents/carer of infant are willing and able to give informed consent for participation in the study. • Less than 12 months of age at enrolment. • Hospitalized with (suspected) RSV infection for

Exclusion criteria

Exclusion criteria: • History of concurrent clinically significant medical illness (not directly attributable to RSV infection) including but not limited to, cardiovascular, respiratory, renal, gastrointestinal, haematology, neurology, endocrinology, immunology, musculoskeletal, oncological or congenital disorders, as judged by the investigator. Specifically excluded examples include, but are not limited to: - Known congenital or acquired immunosuppression - Bronchopulmonary dysplasia/chronic lung disease of infancy - Congenital heart disease* - Down*s syndrome • Prematurity, as defined as gestational age

Design outcomes

Primary

MeasureTime frame
Validation of biomarkers that are associated with severe RSV infection and respiratory sequelae.

Secondary

MeasureTime frame
1. Dynamics of biomarkers in the upper and lower airways of children with RSV infection and compare these with blood and with children without airway infection 2. Validation of currently used case definitions and severity measures for RSV infection in infants 3. Risk factors for severe RSV disease 4. Long-term sequelae of RSV infection in the first year of life

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)