LEARN 2 MOVE 0-2 years: effects of a new intervention program in infants at very high risk for cerebral palsy; a randomized controlled trial |
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Authors: | Tjitske Hielkema Elisa G Hamer Heleen A Reinders-Messelink Carel GB Maathuis Arend F Bos Tineke Dirks Lily van Doormaal Johannes Verheijden Carla Vlaskamp Eline Lindeman Mijna Hadders-Algra |
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Institution: | 1. Department of Emergency Medicine Monash Medical Centre, Clayton Rd, Clayton, Victoria, 3168, Australia 2. Murdoch Children's Research Institute, Flemington Rd, Parkville, Victoria, 3052, Australia 3. Southern Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, Victoria, 3800, Australia 4. Department of Emergency Medicine Royal Children's Hospital, Flemington Rd, Parkville, Victoria, 3052, Australia 5. Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Victoria, 3010, Australia 6. Department of Emergency Medicine Royal Children's Hospital Brisbane, Herston Rd, Herston, Queensland, 4006, Australia 7. Department of Emergency Medicine Princess Margaret Hospital, Roberts Rd, Subiaco, Perth, 6008, Western Australia 8. Department of Emergency Medicine, Sunshine Hospital, 176 Furlong Rd, St Albans, Victoria, 3021, Australia 9. Department of Emergency Medicine Kidz First Hospital, 100 Hospital Road, Papatoetoe, Auckland, 2025, Newzeland 10. Department of Medicine Royal Children's Hospital, Flemington Rd, Parkville, Victoria, 3052, Australia 11. Department of Anaesthesia, Royal Children's Hospital, Flemington Rd, Parkville, Victoria, 3052, Australia
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Abstract: | Background Bronchiolitis is the most common reason for admission of infants to hospital in developed countries. Fluid replacement therapy is required in about 30% of children admitted with bronchiolitis. There are currently two techniques of fluid replacement therapy that are used with the same frequency-intravenous (IV) or nasogastric (NG). The evidence to determine the optimum route of hydration therapy for infants with bronchiolitis is inadequate. This randomised trial will be the first to provide good quality evidence of whether nasogastric rehydration (NGR) offers benefits over intravenous rehydration (IVR) using the clinically relevant continuous outcome measure of duration of hospital admission. Methods/Design A prospective randomised multi-centre trial in Australia and New Zealand where children between 2 and 12 months of age with bronchiolitis, needing non oral fluid replacement, are randomised to receive either intravenous (IV) or nasogastric (NG) rehydration. 750 patients admitted to participating hospitals will be recruited, and will be followed daily during the admission and by telephone 1 week after discharge. Patients with chronic respiratory, cardiac, or neurological disease; choanal atresia; needing IV fluid resuscitation; needing an IV for other reasons, and those requiring CPAP or ventilation are excluded. The primary endpoint is duration of hospital admission. Secondary outcomes are complications, need for ICU admission, parental satisfaction, and an economic evaluation. Results will be analysed using t-test for continuous data, and chi squared for categorical data. Non parametric data will be log transformed. Discussion This trial will define the role of NGR and IVR in bronchiolitis Trail registration The trial is registered with the Australian and New Zealand Clinical Trials Registry - ACTRN12605000033640 |
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