AWMF S2k guideline "Guideline for the prophylaxis of severe illnesses caused by respiratory syncytial virus (RSV) in children at risk"

Update (as of 12.10.2023): Recommendation for starting RSV prophylaxis in high-risk patients

The recommendation was issued by the German Society for Pediatric Infectiology (DGPI); Society for Neonatology and Intensive Care Medicine (GNPI); Society for Pediatric Pneumology (GPP), German Society for Pediatric Cardiology (DGPK) Society of Virology / the German Association for the Control of Viral Diseases (GfV/DVV).

Under the leadership of the German Society for Pediatric Infectiology (DGPI) and with the support of the two mandate holders of Society of Virology e.V., Professor Barbara Gärtner and Professor Thomas Mertens, the AWMF S2k guideline "Guideline for the prophylaxis of severe respiratory syncytial virus (RSV) infections in high-risk children" Update 2023 / Version 5.0 (AWMF Register No. 048 - 012) was successfully revised.

The final approved version is available on the AWMF website under the following link:
https://register.awmf.org/de/leitlinien/detail/048-012.

Scope and purpose of the guideline

This guideline is aimed at pediatricians, neonatologists, pediatric infectiologists, pediatric cardiologists, pediatric pneumologists, neuropaediatricians, pediatric oncologists, virologists and parents of premature infants working in private practice and in hospitals. It is emphasized that recommendations on children at risk have been developed in this guideline. This guideline does not refer to healthy newborns/infants without underlying diseases. It also serves to inform and educate general practitioners and family doctors, parents and caregivers of other high-risk patients and all groups of people who, if appropriately informed, can actively contribute to preventing serious disease progression in children at high risk of severe RSV infections. To this end, the guideline deals in detail with measures for general infection prophylaxis, hygiene measures and the use of drug or vaccination prophylaxis.

What's new?

The guideline contains recommendations for the prophylaxis of respiratory syncytial virus (RSV) infections in children with an increased risk of severe RSV disease. The derived key recommendations have been adapted to the German healthcare system.

The revised 5th version of AWMF guideline 048-012 has been supplemented by new findings on the benefits, risks and effects of non-drug infection prophylaxis and hygiene measures. Previously, only a monoclonal anti-RSV F-protein antibody (palivizumab) was available for drug-based prophylaxis. New findings on the long-term benefits and efficacy of palivizumab prophylaxis in various risk groups have been taken into account. Since September 2022, another monoclonal anti-RSV F-protein antibody (nirsevimab) has been approved in Europe by the EMA(https://www.ema.europa.eu/en/medicines/human/EPAR/beyfortus), which is expected to be available in fall 2023 and will extend the possibility of prophylaxis to healthy newborns/infants without underlying diseases with an advantageous mode of administration (1 injection/season) and lower costs compared to palivizumab. The use of nirsevimab in high-risk infants, which is the subject of this guideline, has only been investigated to a limited extent to date. The possible use in different patients with underlying diseases is discussed in the current guideline and the recommendations have been adapted accordingly.

All statements and recommendations were adapted or reformulated by the guideline group in a formal consensus process, based on background texts with current literature references.

Published under the leadership of the German Society for Pediatric Infectiology (DGPI)
Coordinators:
J. Liese 1/A, J. Forster 20/J, E. Herting 2/B

Further authors:
C. Bührer (deputy) 13/B, R. Dalla-Pozza 12/D, K. Eglin 8/H, B. Gärtner 5/E, A. Groll 9/K, J. Kirschner (deputy) 19/I, B. Lawrenz 7/G, T. Lehrnbecher (deputy) 17/K, T. Mertens (deputy) 16/E, B. Mitschdörfer (deputy) 8/H, A. Rack-Hoch (deputy) 11/A, K. Rodens (deputy) 18/G, H. Rudolph (deputy) 17/F, P. Stock (deputy) 14/C, T. Tenenbaum 6/F, R. Trollmann 10/I, F. Uhlemann (deputy) 15/D, M.Wetzke 3/C

Advisory:
M. Terhardt (external, STIKO)

1 University Hospital Würzburg, Pediatric Clinic
2 University Hospital Schleswig-Holstein, Lübeck Campus, Clinic for Pediatrics and Adolescent Medicine
3 Hannover Medical School, Center for Paediatrics and Adolescent Medicine
4 German Heart Center Munich, Pediatric Cardiology
5 Saarland University Hospital, Institute for Medical Microbiology and Hygiene
6 Sana-Klinikum Lichtenberg, Clinic for Pediatrics and Adolescent Medicine
7 Private practice for pediatric and adolescent medicine, Arnsberg
8 Office of the Federal Association "Das frühgeborene Kind" e.V., Frankfurt am Main
9 Münster University Hospital, Pediatric Clinic
10 Erlangen University Hospital, Pediatric Clinic
11 Ludwig-Maximilians-University Hospital Munich, Dr. von Hauner Children's Hospital
12 Ludwig-Maximilians-Universitätsklinikum München, Department of Pediatric Cardiology and Pediatric Intensive Care Medicine
13 Charité Universitätsmedizin Berlin, Clinic for Neonatology
14 Altonaer Children's Hospital, Hamburg
15 Katharinenhospital, Klinikum Stuttgart
16 Ulm University Hospital, Institute of Virology
17 University Hospital Frankfurt am Main, Clinic for Pediatric and Adolescent Medicine
18 Pediatric and adolescent practice, Langenau
19 University Medical Center Freiburg, Clinic for Neuropaediatrics and Muscular Diseases
20 Merzhausen

A German Society for Pediatric Infectiology (DGPI)
B Society for Neonatology and Pediatric Intensive Care Medicine (GNPI)
C Society for Pediatric Pneumology (GPP)
D German Society for Pediatric Cardiology (DGPK)
E Society of Virology (GFV)
F German Society for Pediatric and Adolescent Medicine (DGKJ)
G Professional Association of Pediatricians and Adolescent Doctors (BVKJ)
H Federal Association "Das frühgeborene Kind" e.V.
I Society for Neuropaediatrics e.V.
J Network for Evidence-based Medicine (EbM Network)
K Society for Pediatric Oncology and Hematology