{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T04:26:56Z","timestamp":1772166416395,"version":"3.50.1"},"reference-count":13,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,4,19]],"date-time":"2020-04-19T00:00:00Z","timestamp":1587254400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2020,4,19]],"date-time":"2020-04-19T00:00:00Z","timestamp":1587254400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004587","name":"Carlos III Health Institute","doi-asserted-by":"crossref","award":["EC11-077"],"award-info":[{"award-number":["EC11-077"]}],"id":[{"id":"10.13039\/501100004587","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Post-extubation upper airway obstruction (UAO) is a frequent complication causing stridor and respiratory distress, which occasionally require reintubation, thereby increasing morbidity and mortality rates. Contradictory results have been obtained in studies assessing the effectiveness of steroids in preventing post-extubation UAO, and the available evidence is limited. We designed a multicentric randomized, placebo-controlled study to explore the effectiveness of dexamethasone in preventing post-extubation UAO in children.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A multicentric, prospective, double-blind, randomized, placebo-controlled, phase IV clinical trial has been designed. The sample will include pediatric patients who are between 1\u2009month and 16\u2009years of age and who have been intubated for more than 48\u2009h. Patients who have airway disorders or who have received steroids within the previous seven days will be excluded. Patients will be randomly assigned to receive either placebo or a therapy with dexamethasone 0.25\u2009mg\/kg every 6\u2009h to be started 6 to 12\u2009h prior to extubation (to a total of four doses). Randomization will be performed at a 1:1 ratio. Follow-up of patients will be carried out for 48\u2009h after extubation. The main objective of this study is to access the reduction in the incidence of moderate to severe UAO symptoms following extubation. Secondary objectives include assessing the decrease in the incidence of reintubation, evaluating the use of additional therapies for UAO, and monitoring potential side effects of dexamethasone.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>The results of this study will contribute to the existing evidence on prophylaxis for post-extubation airway obstruction.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      EudraCT identifier:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrialsregister.eu\/ctr-search\/trial\/2009-016596-30\/ES\">2009\u2013016596-30<\/jats:ext-link>\n                      . Registered on May 11, 2010.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-020-4218-2","type":"journal-article","created":{"date-parts":[[2020,4,19]],"date-time":"2020-04-19T09:02:21Z","timestamp":1587286941000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Effectiveness of steroids versus placebo in preventing upper airway obstruction after extubation in critically ill children: rationale and design of a multicentric, double-blind, randomized study"],"prefix":"10.1186","volume":"21","author":[{"given":"Gema","family":"Manrique","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Butrague\u00f1o-Laiseca","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rafael","family":"Gonz\u00e1lez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Corsino","family":"Rey","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zuri\u00f1e","family":"Mart\u00ednez de\u00a0Compa\u00f1on","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Javier","family":"Gil","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonio","family":"Rodr\u00edguez-N\u00fa\u00f1ez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cecilia","family":"Mart\u00ednez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Silvia","family":"Manrique","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6105-9178","authenticated-orcid":false,"given":"Jes\u00fas","family":"L\u00f3pez-Herce","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,4,19]]},"reference":[{"issue":"11","key":"4218_CR1","doi-asserted-by":"publisher","first-page":"2657","DOI":"10.1097\/01.CCM.0000094228.90557.85","volume":"31","author":"SC Kurachek","year":"2003","unstructured":"Kurachek SC, Newth CJ, Quasney MW, Rice T, Sachdeva RC, Patel NR, et al. Extubation failure in pediatric intensive care: A multiple-center study of risk factors and outcomes. Crit Care Med. 2003;31(11):2657\u201364. https:\/\/doi.org\/10.1097\/01.CCM.0000094228.90557.85.","journal-title":"Crit Care Med"},{"issue":"2","key":"4218_CR2","doi-asserted-by":"publisher","first-page":"198","DOI":"10.1164\/rccm.201506-1064OC","volume":"193","author":"RG Khemani","year":"2016","unstructured":"Khemani RG, Hotz J, Morzov R, Flink R, Kamerkar A, Ross PA, et al. Evaluating risk factors for pediatric post-extubation upper airway obstruction using a physiology-based tool. Am J Respir Crit Care Med. 2016;193(2):198\u2013209. https:\/\/doi.org\/10.1164\/rccm.201506-1064OC.","journal-title":"Am J Respir Crit Care Med"},{"issue":"9","key":"4218_CR3","doi-asserted-by":"publisher","first-page":"1285","DOI":"10.1007\/s00134-014-3358-9","volume":"40","author":"AK Baranwal","year":"2014","unstructured":"Baranwal AK, Meena JP, Singhi SC, Muralidharan J. Dexamethasone pretreatment for 24 h versus 6 h for prevention of postextubation airway obstruction in children: A randomized double-blind trial. Intensive Care Med. 2014;40(9):1285\u201394. https:\/\/doi.org\/10.1007\/s00134-014-3358-9.","journal-title":"Intensive Care Med"},{"key":"4218_CR4","doi-asserted-by":"publisher","first-page":"CD001000","DOI":"10.1002\/14651858.CD001000.pub3","volume":"3","author":"RG Khemani","year":"2009","unstructured":"Khemani RG, Randolph A, Markovitz B. Corticosteroids for the prevention and treatment of post-extubation stridor in neonates, children and adults. Cochrane Database Syst Rev. 2009;3:CD001000. https:\/\/doi.org\/10.1002\/14651858.CD001000.pub3.","journal-title":"Cochrane Database Syst Rev"},{"issue":"4","key":"4218_CR5","first-page":"442","volume":"53","author":"D Malhotra","year":"2009","unstructured":"Malhotra D, Gurcoo S, Qazi S, Gupta S. Randomized comparative efficacy of dexamethasone to prevent postextubation upper airway complications in children and adults in ICU. Indian J Anaesth. 2009;53(4):442\u20139 http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/20640206.","journal-title":"Indian J Anaesth"},{"key":"4218_CR6","doi-asserted-by":"publisher","first-page":"a1841","DOI":"10.1136\/bmj.a1841","volume":"337","author":"T Fan","year":"2008","unstructured":"Fan T, Wang G, Mao B, Xiong Z, Zhang Y, Liu X, et al. Prophylactic administration of parenteral steroids for preventing airway complications after extubation in adults: meta-analysis of randomised placebo controlled trials. BMJ. 2008;337:a1841. https:\/\/doi.org\/10.1136\/bmj.a1841.","journal-title":"BMJ"},{"issue":"5","key":"4218_CR7","doi-asserted-by":"publisher","first-page":"1002","DOI":"10.1016\/j.chest.2017.02.017","volume":"151","author":"A Kuriyama","year":"2017","unstructured":"Kuriyama A, Umakoshi N, Sun R. Prophylactic corticosteroids for prevention of post-extubation stridor and reintubation in adults: a systematic review and meta-analysis. Chest. 2017;151(5):1002\u201310. https:\/\/doi.org\/10.1016\/j.chest.2017.02.017.","journal-title":"Chest"},{"issue":"10","key":"4218_CR8","doi-asserted-by":"publisher","first-page":"1666","DOI":"10.1097\/00003246-199610000-00011","volume":"24","author":"O Anene","year":"1996","unstructured":"Anene O, Meert KL, Uy H, Simpson P, Sarnaik AP. Dexamethasone for the prevention of postextubation airway obstruction: a prospective, randomized, double-blind, placebo-controlled trial. Crit Care Med. 1996;24(10):1666\u20139 http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/8874303.","journal-title":"Crit Care Med"},{"issue":"2","key":"4218_CR9","doi-asserted-by":"publisher","first-page":"289","DOI":"10.1016\/S0022-3476(05)80505-0","volume":"118","author":"DW Tellez","year":"1991","unstructured":"Tellez DW, Galvis AG, Storgion SA, Amer HN, Hoseyni M, Deakers TW. Dexamethasone in the prevention of postextubation stridor in children. J Pediatr. 1991;118(2):289\u201394 http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/1993963.","journal-title":"J Pediatr"},{"issue":"4","key":"4218_CR10","doi-asserted-by":"publisher","first-page":"591","DOI":"10.1016\/S0022-3476(05)81154-0","volume":"121","author":"RJ Couser","year":"1992","unstructured":"Couser RJ, Ferrara TB, Falde B, Johnson K, Schilling CG, Hoekstra RE. Effectiveness of dexamethasone in preventing extubation failure in preterm infants at increased risk for airway edema. J Pediatr. 1992;121(4):591\u20136. https:\/\/doi.org\/10.1016\/S0022-3476(05)81154-0.","journal-title":"J Pediatr"},{"issue":"5","key":"4218_CR11","doi-asserted-by":"publisher","first-page":"555","DOI":"10.1007\/s12098-009-0067-4","volume":"76","author":"AF Saleem","year":"2009","unstructured":"Saleem AF, Bano S, Haque A. Does prophylactic use of dexamethasone have a role in reducing post extubation stridor and reintubation in children? Indian J Pediatr. 2009;76(5):555\u20137. https:\/\/doi.org\/10.1007\/s12098-009-0067-4.","journal-title":"Indian J Pediatr"},{"issue":"3","key":"4218_CR12","first-page":"287","volume":"9","author":"TB Ferrara","year":"1989","unstructured":"Ferrara TB, Georgieff MK, Ebert J, Fisher JB. Routine use of dexamethasone for the prevention of postextubation respiratory distress. J Perinatol. 1989;9(3):287\u201390 http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/2809781.","journal-title":"J Perinatol"},{"issue":"7","key":"4218_CR13","doi-asserted-by":"publisher","first-page":"790","DOI":"10.1001\/archpedi.1975.02120440016004","volume":"129","author":"LM Taussig","year":"1975","unstructured":"Taussig LM, Castro O, Beaudry PH, Fox WW, Bureau M. Treatment of laryngotracheobronchitis (croup). Use of intermittent positive-pressure breathing and racemic epinephrine. 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The final version of this study protocol was approved by ethics committee of Gregorio Mara\u00f1\u00f3n Hospital, Madrid, Spain (IBHGM-ECNC003\u20132010) and the local ethics committee of all participating centers. The principal investigator will ensure that the study is performed in accordance with laws and regulations governing the performance of clinical trials and will communicate protocol modifications to relevant parties. The rationale for using placebo is that the effectiveness of steroids has not been confirmed to date and that other medications have not been proven to be effective in preventing post-extubation complications. The study investigator responsible for patient recruitment in each center will provide oral and written information on the study to the patients or their legal representatives when their age or clinical state prevents them from giving consent. Written informed consent will be required prior to inclusion. The local ethics committees will be given access to original records and databases.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests. Neither participants nor investigators will receive any compensation for participating in this study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"341"}}