Antibiotics (May 2023)
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
- Amy Riddell,
- Aislinn Cook,
- Nathalie Khavessian,
- Sally Ellis,
- Davide Bilardi,
- Erika Correia,
- Tomislav Kostyanev,
- Alessandra Nardone,
- Neal Russell,
- Tuba Vilken,
- Wolfgang Stohr,
- Bethou Adhisivam,
- Iana Rosa Alves de Moraes,
- Nawshad Uddin Ahmed,
- Adrie Bekker,
- Eitan Naaman Berezin,
- Suppawat Boonkasidecha,
- Cristina G. Carvalheiro,
- Prachi Chauhan,
- Sara Chiurchiù,
- Elisavet Chorafa,
- Angela Dramowski,
- Madhusudhan DS,
- Jinxing Feng,
- Shengnan Jia,
- Yuan Kong,
- Mary Kyohere,
- Angeliki Kontou,
- Sorasak Lochindarat,
- Maia De Luca,
- Aripfani Mphaphuli,
- Marisa M. Mussi-Pinhata,
- Sheila Murunga,
- Firdose Lambey Nakwa,
- Sushma Nangia,
- Erinah Nassolo,
- Ngoc Thi Bin Hoang,
- Christina W. Obiero,
- Linus Olson,
- Wang Ping,
- Nishad Plakkal,
- Priyanka Prasad,
- Kanchana Preedisripipat,
- Sheikh Wasik Rahman,
- Tiffany Seef,
- Pra-ornsuda Sukrakanchana,
- Reenu Thomas,
- Zhang Yu,
- Qiaoru Zhang,
- A. Sarah Walker,
- Julia Bielicki,
- Paul T. Heath,
- Michael Sharland,
- Tatiana Munera-Huertas
Affiliations
- Amy Riddell
- Centre for Neonatal and Paediatric Infection, St. George’s University of London, London SW17 0RE, UK
- Aislinn Cook
- Centre for Neonatal and Paediatric Infection, St. George’s University of London, London SW17 0RE, UK
- Nathalie Khavessian
- GARDP, 1202 Geneva, Switzerland
- Sally Ellis
- GARDP, 1202 Geneva, Switzerland
- Davide Bilardi
- Fondazione Penta ETS, 35127 Padova, Italy
- Erika Correia
- GARDP, 1202 Geneva, Switzerland
- Tomislav Kostyanev
- Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute, University of Antwerp, 2610 Antwerpen, Belgium
- Alessandra Nardone
- Fondazione Penta ETS, 35127 Padova, Italy
- Neal Russell
- Centre for Neonatal and Paediatric Infection, St. George’s University of London, London SW17 0RE, UK
- Tuba Vilken
- Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute, University of Antwerp, 2610 Antwerpen, Belgium
- Wolfgang Stohr
- MRC Clinical Trials Unit, University College London, London WC1V 6LJ, UK
- Bethou Adhisivam
- Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Pondicherry 605006, India
- Iana Rosa Alves de Moraes
- Santa Casa de São Paulo, Sao Paulo 01221-010, Brazil
- Nawshad Uddin Ahmed
- Child Health Research Foundation, Dhaka 1207, Bangladesh
- Adrie Bekker
- Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town 8000, South Africa
- Eitan Naaman Berezin
- Santa Casa de São Paulo, Sao Paulo 01221-010, Brazil
- Suppawat Boonkasidecha
- Queen Sirikit National Institute of Child Health, Bangkok 10400, Thailand
- Cristina G. Carvalheiro
- Department of Pediatrics, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto 14049-900, Brazil
- Prachi Chauhan
- Department of Neonatology, Lady Hardinge Medical College and Kalawati Saran Children’s Hospital, New Delhi 110001, India
- Sara Chiurchiù
- Academic Department of Pediatrics (DPUO), Infectious Disease Unit, Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
- Elisavet Chorafa
- Infectious Diseases Unit, 3rd Dept Pediatrics, School of Medicine, Faculty of Health Sciences, Aristotle University and Hippokration General Hospital, 546 43 Thessaloniki, Greece
- Angela Dramowski
- Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town 8000, South Africa
- Madhusudhan DS
- Seth G. S. Medical College & KEM Hospital, Mumbai 400012, India
- Jinxing Feng
- Department of Neonatology, Shenzhen Children’s Hospital, Shenzhen 518048, China
- Shengnan Jia
- Department of Neonatology, Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health, Beijing 100051, China
- Yuan Kong
- Clinical Laboratory, Shenzhen Children’s Hospital, Shenzhen 518048, China
- Mary Kyohere
- MUJHU Research Collaboration, Kampala P.O. Box 23491, Uganda
- Angeliki Kontou
- 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
- Sorasak Lochindarat
- Queen Sirikit National Institute of Child Health, Bangkok 10400, Thailand
- Maia De Luca
- Academic Department of Pediatrics (DPUO), Infectious Disease Unit, Bambino Gesù Children’s Hospital, IRCCS, 00165 Rome, Italy
- Aripfani Mphaphuli
- 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
- Marisa M. Mussi-Pinhata
- Department of Pediatrics, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto 14049-900, Brazil
- Sheila Murunga
- Clinical Research Department, KEMRI-Wellcome Trust Research Programme, Kilifi P.O. Box 230, Kenya
- Firdose Lambey Nakwa
- Department of Paediatrics and Child Health, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 1864, South Africa
- Sushma Nangia
- Department of Neonatology, Lady Hardinge Medical College and Kalawati Saran Children’s Hospital, New Delhi 110001, India
- Erinah Nassolo
- MUJHU Research Collaboration, Kampala P.O. Box 23491, Uganda
- Ngoc Thi Bin Hoang
- Department of Microbiology, Vietnam National Children’s Hospital, Hanoi 100000, Vietnam
- Christina W. Obiero
- Clinical Research Department, KEMRI-Wellcome Trust Research Programme, Kilifi P.O. Box 230, Kenya
- Linus Olson
- Department of Women’s and Children’s Health, Karolinska institutet, Stockholm, Sweden and Department of Global Public Health, Karolinska Institutet, 171 77 Stockholm, Sweden
- Wang Ping
- Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100026, China
- Nishad Plakkal
- Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Pondicherry 605006, India
- Priyanka Prasad
- Seth G. S. Medical College & KEM Hospital, Mumbai 400012, India
- Kanchana Preedisripipat
- Chiangrai Prachanukroh Hospital, Chiang Rai 57000, Thailand
- Sheikh Wasik Rahman
- Child Health Research Foundation, Dhaka 1207, Bangladesh
- Tiffany Seef
- 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
- Pra-ornsuda Sukrakanchana
- AMS-PHPT Research Collaboration, Chiang Mai University, Chiang Mai 50200, Thailand
- Reenu Thomas
- Department of Paediatrics and Child Health, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 1864, South Africa
- Zhang Yu
- Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100026, China
- Qiaoru Zhang
- Department of Neonatology, Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health, Beijing 100051, China
- A. Sarah Walker
- MRC Clinical Trials Unit, University College London, London WC1V 6LJ, UK
- Julia Bielicki
- Centre for Neonatal and Paediatric Infection, St. George’s University of London, London SW17 0RE, UK
- Paul T. Heath
- Centre for Neonatal and Paediatric Infection, St. George’s University of London, London SW17 0RE, UK
- Michael Sharland
- Centre for Neonatal and Paediatric Infection, St. George’s University of London, London SW17 0RE, UK
- Tatiana Munera-Huertas
- Centre for Neonatal and Paediatric Infection, St. George’s University of London, London SW17 0RE, UK
- DOI
- https://doi.org/10.3390/antibiotics12050923
- Journal volume & issue
-
Vol. 12,
no. 5
p. 923
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.
Keywords
- neonatal sepsis
- antimicrobial resistance
- antibiotic treatment
- LMIC
- global collaboration
- empiric antibiotics
