Challenges in the Implementation of the NeoOBS Study, a Global Pragmatic Observational Cohort Study, to Investigate the Aetiology and Management of Neonatal Sepsis in the Hospital Setting

Author:

Riddell Amy1,Cook Aislinn1ORCID,Khavessian Nathalie2,Ellis Sally2,Bilardi Davide3ORCID,Correia Erika2,Kostyanev Tomislav4ORCID,Nardone Alessandra3,Russell Neal1,Vilken Tuba4ORCID,Stohr Wolfgang5ORCID,Adhisivam Bethou6,Moraes Iana Rosa Alves de7,Ahmed Nawshad Uddin8ORCID,Bekker Adrie9,Berezin Eitan Naaman7ORCID,Boonkasidecha Suppawat10,Carvalheiro Cristina G.11ORCID,Chauhan Prachi12,Chiurchiù Sara13,Chorafa Elisavet14,Dramowski Angela9,DS Madhusudhan15,Feng Jinxing16,Jia Shengnan17,Kong Yuan18,Kyohere Mary19,Kontou Angeliki20ORCID,Lochindarat Sorasak10,De Luca Maia13ORCID,Mphaphuli Aripfani21,Mussi-Pinhata Marisa M.11ORCID,Murunga Sheila22,Nakwa Firdose Lambey23,Nangia Sushma12ORCID,Nassolo Erinah19,Hoang Ngoc Thi Bin24,Obiero Christina W.2225,Olson Linus26ORCID,Ping Wang2728,Plakkal Nishad6,Prasad Priyanka15,Preedisripipat Kanchana29,Rahman Sheikh Wasik8ORCID,Seef Tiffany21,Sukrakanchana Pra-ornsuda30ORCID,Thomas Reenu23ORCID,Yu Zhang2728,Zhang Qiaoru17,Walker A. Sarah5,Bielicki Julia1,Heath Paul T.1,Sharland Michael1,Munera-Huertas Tatiana1

Affiliation:

1. Centre for Neonatal and Paediatric Infection, St. George’s University of London, London SW17 0RE, UK

2. GARDP, 1202 Geneva, Switzerland

3. Fondazione Penta ETS, 35127 Padova, Italy

4. Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute, University of Antwerp, 2610 Antwerpen, Belgium

5. MRC Clinical Trials Unit, University College London, London WC1V 6LJ, UK

6. Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Pondicherry 605006, India

7. Santa Casa de São Paulo, Sao Paulo 01221-010, Brazil

8. Child Health Research Foundation, Dhaka 1207, Bangladesh

9. Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town 8000, South Africa

10. Queen Sirikit National Institute of Child Health, Bangkok 10400, Thailand

11. Department of Pediatrics, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto 14049-900, Brazil

12. Department of Neonatology, Lady Hardinge Medical College and Kalawati Saran Children’s Hospital, New Delhi 110001, India

13. Academic Department of Pediatrics (DPUO), Infectious Disease Unit, Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy

14. Infectious Diseases Unit, 3rd Dept Pediatrics, School of Medicine, Faculty of Health Sciences, Aristotle University and Hippokration General Hospital, 546 43 Thessaloniki, Greece

15. Seth G. S. Medical College & KEM Hospital, Mumbai 400012, India

16. Department of Neonatology, Shenzhen Children’s Hospital, Shenzhen 518048, China

17. Department of Neonatology, Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health, Beijing 100051, China

18. Clinical Laboratory, Shenzhen Children’s Hospital, Shenzhen 518048, China

19. MUJHU Research Collaboration, Kampala P.O. Box 23491, Uganda

20. 1st Neonatology Department and Neonatal Intensive Care Unit, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki, Hippokration General Hospital, 546 42 Thessaloniki, Greece

21. School of Clinical Medicine, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa AND Department of Paediatrics and Child Health, Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg 2193, South Africa

22. Clinical Research Department, KEMRI-Wellcome Trust Research Programme, Kilifi P.O. Box 230, Kenya

23. Department of Paediatrics and Child Health, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 1864, South Africa

24. Department of Microbiology, Vietnam National Children’s Hospital, Hanoi 100000, Vietnam

25. Amsterdam UMC, University of Amsterdam, Emma Children’s Hospital, Department of Global Health, 1081 Amsterdam, The Netherlands

26. Department of Women’s and Children’s Health, Karolinska institutet, Stockholm, Sweden and Department of Global Public Health, Karolinska Institutet, 171 77 Stockholm, Sweden

27. Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100026, China

28. Beijing Maternal and Child Health Care Hospital, Beijing 100026, China

29. Chiangrai Prachanukroh Hospital, Chiang Rai 57000, Thailand

30. AMS-PHPT Research Collaboration, Chiang Mai University, Chiang Mai 50200, Thailand

Abstract

Neonatal sepsis is a significant cause of mortality and morbidity in low- and middle-income countries. To deliver high-quality data studies and inform future trials, it is crucial to understand the challenges encountered when managing global multi-centre research studies and to identify solutions that can feasibly be implemented in these settings. This paper provides an overview of the complexities faced by diverse research teams in different countries and regions, together with actions implemented to achieve pragmatic study management of a large multi-centre observational study of neonatal sepsis. We discuss specific considerations for enrolling sites with different approval processes and varied research experience, structures, and training. Implementing a flexible recruitment strategy and providing ongoing training were necessary to overcome these challenges. We emphasize the attention that must be given to designing the database and monitoring plans. Extensive data collection tools, complex databases, tight timelines, and stringent monitoring arrangements can be problematic and might put the study at risk. Finally, we discuss the complexities added when collecting and shipping isolates and the importance of having a robust central management team and interdisciplinary collaborators able to adapt easily and make swift decisions to deliver the study on time and to target. With pragmatic approaches, appropriate training, and good communication, these challenges can be overcome to deliver high-quality data from a complex study in challenging settings through a collaborative research network.

Funder

Global Antibiotic Research and Development Partnership

Bill & Melinda Gates Foundation

German Federal Ministry of Education and Research

German Federal Ministry of Health

Government of the Principality of Monaco

Indian Council for Medical Research

Japanese Ministry of Health, Labour and Welfare

Netherlands Ministry of Health, Welfare and Sport

South African Medical Research Council

UK Department of Health and Social Care

UK Medical research Council

Wellcome Trust

Leo Model Foundation

Luxembourg Ministry of Development Cooperation and Humanitarian Aid

Luxembourg Ministry of Health

Médecins Sans Frontières

Swiss Federal Office of Public Health

UK Foreign, Commonwealth & Development Office

Publisher

MDPI AG

Subject

Pharmacology (medical),Infectious Diseases,Microbiology (medical),General Pharmacology, Toxicology and Pharmaceutics,Biochemistry,Microbiology

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