Ed Oakley1, Meredith Borland2, Jocelyn Neutze3, Jason Acworth4, David Krieser5, Stuart Dalziel6, Andrew Davidson7, Susan Donath8, Kim Jachno9, Mike South10, Theane Theophilos11, Franz E Babl12. 1. Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Emergency Medicine, Monash Medical Centre, Melbourne, VIC, Australia; Southern Clinical School Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia. Electronic address: ed.oakley@rch.org.au. 2. Department of Emergency Medicine, Princess Margaret Hospital, Perth, WA, Australia; School of Paediatrics and Child Health and School of Primary, Rural and Aboriginal Health, University of Western Australia, Perth, WA, Australia. 3. Department of Emergency Medicine, Kidz First Hospital, Middlemore, Auckland, New Zealand. 4. Department of Emergency Medicine, Royal Children's Hospital, Brisbane, QLD, Australia; Queensland Children's Medical Research Institute, Brisbane, QLD, Australia; Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia. 5. Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Emergency Medicine, Sunshine Hospital, Melbourne, VIC, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia. 6. Children's Emergency Department, Starship Children's Hospital, Auckland, New Zealand; Liggins Institute, University of Auckland, Auckland, New Zealand. 7. Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia; Department of Anaesthesia, Royal Children's Hospital, Melbourne, VIC, Australia. 8. Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia. 9. Murdoch Children's Research Institute, Melbourne, VIC, Australia. 10. Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia; Department of Medicine, Royal Children's Hospital, Melbourne, VIC, Australia. 11. Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Emergency Medicine, Royal Children's Hospital, Melbourne, VIC, Australia. 12. Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, VIC, Australia; Department of Emergency Medicine, Royal Children's Hospital, Melbourne, VIC, Australia.
Abstract
BACKGROUND: Bronchiolitis is the most common lower respiratory tract infection in infants and the leading cause of hospital admission. Hydration is a mainstay of treatment, but insufficient evidence exists to guide clinical practice. We aimed to assess whether intravenous hydration or nasogastric hydration is better for treatment of infants. METHODS: In this multicentre, open, randomised trial, we enrolled infants aged 2-12 months admitted to hospitals in Australia and New Zealand with a clinical diagnosis of bronchiolitis during three bronchiolitis seasons (April 1-Oct 31, in 2009, 2010, and 2011). We randomly allocated infants to nasogastric hydration or intravenous hydration by use of a computer-generated sequence and opaque sealed envelopes, with three randomly assigned block sizes and stratified by hospital site and age group (2-<6 months vs 6-12 months). The primary outcome was length of hospital stay, assessed in all randomly assigned infants. Secondary outcomes included rates of intensive-care unit admission, adverse events, and success of insertion. This trial is registered with the Australian and New Zealand clinical trials registry, ACTRN12605000033640. FINDINGS:Mean length of stay for 381 infants assignednasogastric hydration was 86·6 h (SD 58·9) compared with 82·2 h (58·8) for 378 infants assigned intravenous hydration (absolute difference 4·5 h [95% CI -3·9 to 12·9]; p=0·30). Rates of admission to intensive-care units, need for ventilatory support, and adverse events did not differ between groups. At randomisation, seven infants assigned nasogastric hydration were switched to intravenous hydrationand 56 infants assigned intravenous hydration were switched to nasogastric hydration because the study-assigned method was unable to be inserted. For those infants who had data available for successful insertion, 275 (85%) of 323 infants in the nasogastric hydration group and 165 (56%) of 294 infants in theintravenous hydration group required only one attempt for successful insertion. INTERPRETATION:Intravenous hydration and nasogastric hydration are appropriate means to hydrate infants with bronchiolitis. Nasogastric insertion might require fewer attempts and have a higher success rate of insertion than intravenous hydration. FUNDING: Australian National Health and Medical Research Council, Samuel Nissen Charitable Foundation (Perpetual), Murdoch Children's Research Institute, Victorian Government.
RCT Entities:
BACKGROUND:Bronchiolitis is the most common lower respiratory tract infection in infants and the leading cause of hospital admission. Hydration is a mainstay of treatment, but insufficient evidence exists to guide clinical practice. We aimed to assess whether intravenous hydration or nasogastric hydration is better for treatment of infants. METHODS: In this multicentre, open, randomised trial, we enrolled infants aged 2-12 months admitted to hospitals in Australia and New Zealand with a clinical diagnosis of bronchiolitis during three bronchiolitis seasons (April 1-Oct 31, in 2009, 2010, and 2011). We randomly allocated infants to nasogastric hydration or intravenous hydration by use of a computer-generated sequence and opaque sealed envelopes, with three randomly assigned block sizes and stratified by hospital site and age group (2-<6 months vs 6-12 months). The primary outcome was length of hospital stay, assessed in all randomly assigned infants. Secondary outcomes included rates of intensive-care unit admission, adverse events, and success of insertion. This trial is registered with the Australian and New Zealand clinical trials registry, ACTRN12605000033640. FINDINGS: Mean length of stay for 381 infants assigned nasogastric hydration was 86·6 h (SD 58·9) compared with 82·2 h (58·8) for 378 infants assigned intravenous hydration (absolute difference 4·5 h [95% CI -3·9 to 12·9]; p=0·30). Rates of admission to intensive-care units, need for ventilatory support, and adverse events did not differ between groups. At randomisation, seven infants assigned nasogastric hydration were switched to intravenous hydration and 56 infants assigned intravenous hydration were switched to nasogastric hydration because the study-assigned method was unable to be inserted. For those infants who had data available for successful insertion, 275 (85%) of 323 infants in the nasogastric hydration group and 165 (56%) of 294 infants in the intravenous hydration group required only one attempt for successful insertion. INTERPRETATION: Intravenous hydration and nasogastric hydration are appropriate means to hydrate infants with bronchiolitis. Nasogastric insertion might require fewer attempts and have a higher success rate of insertion than intravenous hydration. FUNDING: Australian National Health and Medical Research Council, Samuel Nissen Charitable Foundation (Perpetual), Murdoch Children's Research Institute, Victorian Government.
Authors: Sharon O'Brien; Sally Wilson; Fenella J Gill; Elizabeth Cotterell; Meredith L Borland; Edward Oakley; Stuart R Dalziel Journal: BMC Med Res Methodol Date: 2018-02-12 Impact factor: 4.615
Authors: Donna Franklin; Stuart Dalziel; Luregn J Schlapbach; Franz E Babl; Ed Oakley; Simon S Craig; Jeremy S Furyk; Jocelyn Neutze; Kam Sinn; Jennifer A Whitty; Kristen Gibbons; John Fraser; Andreas Schibler Journal: BMC Pediatr Date: 2015-11-14 Impact factor: 2.125