BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available
Total Page:16
File Type:pdf, Size:1020Kb
BMJ Open: first published as 10.1136/bmjopen-2019-031086 on 14 October 2019. Downloaded from BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] http://bmjopen.bmj.com/ on September 27, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-031086 on 14 October 2019. Downloaded from International variations in preventive strategies and factors associated with surgically treated necrotizing enterocolitis in extremely preterm infants ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2019-031086 Article Type: Research Date Submitted by the 15-Apr-2019 Author: Complete List of Authors: Adams, Mark; Universitätsspital Zürich, Department of Neonatology; University Zurich, Epidemiology, Biostatistics and Prevention Institute Bassler, Dirk; University Hospital Zurich, Department of Neonatology Darlow, Brian; University of Otago Lui, Kei; Royal Hospital for Women, Department of Newborn Care; University of New South Wales Reichman, Brian; Sheba Medical Centre, Gertner Institute for Epidemiology and Health Policy Research Hakansson, Stellan; Umeå University Hospital, Department of Clinical Sciences/Pediatrics Norman, Mikael; Department of Clinical Science, Intervention and Technology, Karolinska Institute, Department of Clinical Science, Intervention and Technology http://bmjopen.bmj.com/ Lee, Shoo; Mount Sinai Hospital and University of Toronto, Department of Paediatrics Helenius, Kjell; Turku University Hospital, Department of Pediatrics Lehtonen, Liisa; University of Turku Finland, Department of Pediatrics San Feliciano, Laura; University Hospital Salamanca, Division of Neonatology Vento, Maximo; University of Valencia, Division of Neonatology and Health Research Institute La Fe Moroni, Marco; Anna Meyer Children’s University Hospital, Neonatal on September 27, 2021 by guest. Protected copyright. Intensive Care Unit Beltempo, Marc; Montreal Children’s Hospital, McGill University, Department of Pediatrics Yang, Junmin; Mount Sinai Hospital and University of Toronto, Department of Paediatrics Shah, Prakesh; Mount Sinai Hospital and University of Toronto, Department of Paediatrics NEONATOLOGY, Paediatric gastroenterology < PAEDIATRICS, Keywords: PERINATOLOGY, PAEDIATRICS For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 71 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-031086 on 14 October 2019. Downloaded from 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40 41 on September 27, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 71 1 2 International variations in preventive strategies and factors associated with surgically 3 treated necrotizing enterocolitis in extremely preterm infants BMJ Open: first published as 10.1136/bmjopen-2019-031086 on 14 October 2019. Downloaded from 4 5 Mark Adams, PhD1, Dirk Bassler, MD, MSc1, Brian A Darlow, MD2, Kei Lui, MD3, Brian 6 4 5 6 7 Reichman, MBChB , Stellan Håkansson, MD , Mikael Norman, MD , Shoo K Lee, MBBS, 7,8 9 9 10 8 PhD , Kjell K Helenius, MD , Liisa Lehtonen, MD , Laura San Feliciano, MD , Maximo 9 Vento, MD, PhD11, Marco Moroni, MD12, Marc Beltempo, MD13, Junmin Yang, PhD7, 10 Prakesh S Shah, MD, MSc7,8; on behalf of the International Network for Evaluating 11 Outcomes (iNeo) of Neonatesǂ 12 ǂGroup Information: Investigators of the International Network for Evaluating Outcomes 13 14 (iNeo) of Neonates are provided in the Acknowledgements 15 16 Affiliations: 17 1Department of Neonatology, University Hospital Zurich, University of Zurich, Switzerland; 18 Department of Paediatrics,For University peer of reviewOtago, Christchurch, only New Zealand; 3Royal Hospital 19 for Women, National Perinatal Epidemiology and Statistic Unit, University of New South 20 Wales, Randwick, Australia; 4Gertner Institute for Epidemiology and Health Policy Research, 21 5 22 Sheba Medical Centre, Israel; Department of Clinical Sciences/Pediatrics, Umeå University 6 23 Hospital, Umeå, Sweden; Department of Neonatal Medicine, Karolinska University Hospital 24 and Karolinska Institutet, Stockholm, Sweden; 7Department of Paediatrics, Mount Sinai 25 Hospital and University of Toronto, Toronto, Canada; 8Maternal-Infant Care Research 26 Centre, Mount Sinai Hospital, Toronto, Canada; 9Department of Pediatrics, Turku University 27 Hospital and University of Turku, Turku, Finland; 10Division of Neonatology, University 28 Hospital Salamanca, Salamanca, Spain; 11Division of Neonatology and Health Research 29 12 30 Institute La Fe, University of Valencia, Valencia, Spain; Neonatal Intensive Care Unit, 13 31 Anna Meyer Children’s University Hospital, Florence, Italy; Department of Pediatrics, 32 Montreal Children’s Hospital, McGill University, Montreal, QC, Canada. 33 34 Address correspondence to: Mark Adams, Department of Neonatology, University Hospital 35 Zurich, Frauenklinikstrasse 10, 8091 Zurich, Switzerland; Tel. +4143 253 3034; 36 37 E-mail: [email protected]. http://bmjopen.bmj.com/ 38 39 Short title: NEC prevention practices and their impact on outcome 40 41 Financial Disclosure Statement 42 Mark Adams receives a salary as network coordinator for the Swiss Neonatal Network. The 43 remaining authors have indicated they have no financial relationships relevant to this article to 44 45 disclose. on September 27, 2021 by guest. Protected copyright. 46 47 Funding Sources: Funding for iNeo has been provided by a Canadian Institutes of Health 48 Research Chair in Reproductive and Child Health Services and Policy Research (APR- 49 126340) held by PSS. The Australian and New Zealand Neonatal Network is predominantly 50 funded by membership contributions from participating centres. The Canadian Neonatal 51 Network is supported by a team grant from the Canadian Institutes of Health Research (CTP 52 53 87518), the Ontario Ministry of Health, and individual participating centres. The Finnish 54 Medical Birth Register is governmentally funded and kept by the National Institute for Health 55 and Welfare (THL). The Israel Neonatal Network very low birth weight infant database is 56 partially funded by the Israel Center for Disease Control and the Ministry of Health. The 57 Neonatal Research Network of Japan is partly funded by a Health Labour Sciences Research 58 Grant from the Ministry of Health, Labour and Welfare of Japan. SEN1500 is supported by 59 60 funds from the Spanish Neonatal Society (SENeo). The Swedish Neonatal Quality Register is funded by the Swedish Government (Ministry of Health and Social Affairs) and the body of 1 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 71 BMJ Open 1 2 regional health care providers (County Councils). SwissNeoNet is partially funded by 3 participating units in the form of membership fees. Tuscany Neonatal Network is funded by BMJ Open: first published as 10.1136/bmjopen-2019-031086 on 14 October 2019. Downloaded from 4 the Tuscany Region. The United Kingdom Neonatal Collaborative receives no core funding. 5 6 7 Role of the Funders/Sponsors: The funding bodies played no role in the design and conduct 8 of the study; collection, management, analysis, and interpretation of the data; preparation, 9 review, or approval of the manuscript; and decision to submit the manuscript for publication. 10 11 12 Conflict of Interest Statement: Mark Adams receives a salary as network coordinator for the 13 Swiss Neonatal Network. The remaining authors have indicated they have no potential 14 conflicts of interest relevant to this article to disclose 15 16 List of abbreviations 17 ANZNN: Australia/New Zealand Neonatal Network; CNN: Canadian Neonatal Network; 18 For peer review only 19 FINMBR: Finish Medical Birth Register; GA: gestational age; INN: Israel Neonatal Network; 20 NEC: Necrotizing enterocolitis; NICU: neonatal intensive care unit; OR: odds ratio; PDA: 21 patent ductus arteriosus; SEN1500 Spanish Neonatal Network; SNQ: Swedish Neonatal 22 Quality Register; SR: standardized ratio; SwissNeoNet: Swiss Neonatal Network; TuscanNN: 23 Tuscany Neonatal Network in Italy. 24 25 26 27 ABSTRACT 28 Objectives: To compare necrotizing enterocolitis (NEC) prevention practices and NEC 29 30 associated factors between units from eight countries of the International Network for 31 Evaluation of Outcomes of Neonates (iNeo), and to assess their association with surgical NEC 32 rates. 33 Design: Prospective unit-level survey