Article summary
Strengths
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INFORM RSV is large enough to identify drivers of spatial and temporal distribution.
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Sequencing platform was selected based on a comparative pilot study.
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RSV is cultured to translate genotype to function.
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INFORM RSV is collaborating with others including researchers from the UEDIN, WHO and NIH.
Limitations
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Clinical information is limited, no follow-up data available.
Background
Study objectives
Primary objective
Secondary objectives
Methods
Study design
Study participants
Inclusion Criteria | Exclusion Criteria |
---|---|
Age < 5 years | Use of palivizumab or experimental medication for RSV |
Confirmed RSV positive diagnosis | |
Written informed parental consent |
Sample collection, storage and shipment
Nucleic acid extraction and RSV subtyping
RT-PCR amplification of RSV genomes and next generation sequencing
Primer | Sequence (5′-3′) |
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RSVA-fragment 1-Fw | AAAAATGCGTACWACAAACTTGC |
RSVA-fragment 1-Rev | GTTGGTCCTTGGTTTTGGAC |
RSVA-fragment 2-Fw | CACAGTGACTGACAACAAAGGAG |
RSVA-fragment 2-Rev | GCTCATGGCAACACATGC |
RSVA-fragment 3-Fw | CGAGGTCATTGCTTGAATGG |
RSVA-fragment 3-Rev | CACCACCACCAAATAACATGG |
RSVA-fragment 4-Fw | AGGGTGGTGTCAAAAACTATGG |
RSVA-fragment 4-Rev | ACGAGAAAAAAAGTGTCAAAAACT |
RSVB-fragment 1-Fw | AAAAATGCGTACTACAAACTTGC |
RSVB-fragment 1-Rev | TTGTGCTTGGCTTGTTGTTC |
RSVB-fragment 2-Fw | AAGGGTTAGCCCATCCAAMC |
RSVB-fragment 2-Rev | TGCTAAGGCTGATGTCTTTCC |
RSVB-fragment 3-Fw | GTCCTCGTCTGARCAAATTGC |
RSVB-fragment 3-Rev | TAGGTCCTCTTTCACCACGAG |
RSVB-fragment 4-Fw | GAGGGATCCACAGGCTTTAGG |
RSVB-fragment 4-Rev | ACGAGAAAAAAGTGTCAAAAACT |
RSV genome assembly and annotation
RSV culture
Data collection and management
Variables | Description |
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Site ID | |
Study ID | |
Country | |
Visiting date | |
Age | Age in months |
Gender | Male / Female |
Length of stay | < 24 h / > 24 h / Outpatient |
Referring department | Paediatric Intensive Care Unit / General Paediatric Ward / Outpatient clinic (including Emergency Department) |
RSV detection method | PCR / molecular point-of-care-test |
RSV subtype | A / B |
Storage temperature | -20 °C / -80 °C |
Gestational age at birth | Calculated duration of pregnancy in weeks |
Severe comorbidity | Congenital heart disease / Hematological malignancies / Neurological disease / Bronchopulmonary dysplasia / Other (specified in provided space) |
Breastfeeding | Yes (exclusive) / No / Partial |
Day care attendance | Yes / No |
Current hay fever, asthma and/or eczema in either parent | Yes / No |
Smoking in household | Yes / No |
Other children in household under the age of 6 | Yes / No |
Outcomes
Primary endpoint
Secondary endpoints
Sample size calculation
Discussion
Supplementary information
Acknowledgements
Patient and public involvement
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At what stage in the research process were patients/public first involved in the research and how?Answer: We have an active patient advisory board that has been part of the research team from the start. This includes prioritizing research questions, designing the study and involvement of knowledge transfer of study results.
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How were the research question(s) and outcome measures developed and informed by their priorities, experience, and preferences?Answer: Research questions and outcomes were developed by the UMC Utrecht and approved by the patient advisory board.
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How were patients/public involved in the design of this study?Answer: See above.
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How were they involved in the recruitment to and conduct of the study?Answer: Patients have not been involved in recruitment other than optimizing the patient information.
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Were they asked to assess the burden of the intervention and time required to participate in the research?Answer: See above.
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How were (or will) patients and the public be involved in choosing the methods and agreeing?Answer: See above.
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Plans for dissemination of the study results to participants and wider relevant communities?Answer: See above.
Ethics approval and consent to participate
- The Netherlands: The Medical Research Ethics Committee of the UMC Utrecht (reference number WAG/mb/17/016170).
- Italy: Ethics Committee for Clinical Testing of the Province of Padova of the Padova Hospital (no. 345 of 27/10/2016).
- Russia: The Department for Science, Innovation Development and Management of Health and Biological Risks, Ministry of Health of the Russian Federation.
- Germany: Ethics Committee of the Medical Faculty of the Philipps University Marburg.
- France: Ethics Committee Southwest and Overseas of the Créteil Intercommunal Hospital Centre (ID-RCB No.: 2018-A02360–55 (file 1–18-73).
- Spain: Ethics Committee for Research Santiago-Lugo of the Hospital Centre University of Santiago (registration code 2017/397).
- South Korea: Medical Research Committee of the Seoul National University Hospital.
- Finland: Ethics Committee of the Hospital District of Southwest Finland, Turku.
- Australia: Human Research Ethics Committee of the Perth Children’s Hospital.
- Brazil: The Research Ethics Committee of the Centro INFANT at Pontificia Universidade Catolica de Rio Grande do Sul (opinion number 2,569,872).
- Canada: Hamilton Integrated Research Ethics Board of the McMaster University.
- Canada: Research Ethics Board of the McGill University Health Centre.
- South Africa: Human Research Ethics Committee of the University of the Witwatersrand Johannesburg (no. M170966).
- Japan: Research Ethics Committee of the Fukushima Medical University (no. 29212).
- The United Kingdom: Health Research Authority of the King’s College Hospital (no. 17/EM/0469).
- Taiwan: Mackay Memorial Hospital Institutional Review Board (no. 19MMHIS171e).
- Chile: Ethics Committee for Research on Human Subjects of the Faculty of Medicine, University of Chile.
- Mexico: Ethics Committee of the University Autónoma De Nuevo León, Faculty of Medicine.Written informed consent was obtained from parent(s)/legal representative(s) of all children participating in the study.