{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,9]],"date-time":"2026-02-09T22:38:48Z","timestamp":1770676728252,"version":"3.49.0"},"reference-count":18,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2021,6,22]],"date-time":"2021-06-22T00:00:00Z","timestamp":1624320000000},"content-version":"unspecified","delay-in-days":21,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,5,13]]},"published-print":{"date-parts":[[2021,6]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Respiratory distress syndrome is a complication of prematurity and extremely preterm infants born before 28 weeks\u2019 gestation often require endotracheal intubation and mechanical ventilation. In this high-risk population, mechanical ventilation is associated with lung injury and contributes to bronchopulmonary dysplasia. Therefore, clinicians attempt to extubate infants as quickly and use non-invasive respiratory support such as nasal continuous positive airway pressure (CPAP) to facilitate the transition. However, approximately 60% of extremely preterm infants experience \u2018extubation failure\u2019 and require reintubation. While CPAP pressures of 5\u20138 cm H2O are commonly used, the optimal CPAP pressure is unknown, and higher pressures may be beneficial in avoiding extubation failure. Our trial is the Extubation CPAP Level Assessment Trial (\u00c9CLAT). The aim of this trial is to compare higher CPAP pressures 9\u201311 cm H2O with a current standard pressures of 6\u20138 cmH2O on extubation failure in extremely preterm infants.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>200 extremely preterm infants will be recruited prior to their first extubation from mechanical ventilation to CPAP. This is a parallel group randomised controlled trial. Infants will be randomised to one of two set CPAP pressures: CPAP 10 cmH2O (intervention) or CPAP 7 cmH2O (control). The primary outcome will be extubation failure (reintubation) within 7\u2009days. Statistical analysis will follow standard methods for randomised trials on an intention to treat basis. For the primary outcome, this will be by intention to treat, adjusted for the prerandomisation strata (GA and centre). We will use the appropriate parametric and non-parametric statistical tests.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and dissemination<\/jats:title><jats:p>Ethics approval has been granted by the Monash Health Human Research Ethics Committees. Amendments to the trial protocol will be submitted for approval. The findings of this study will be written into a clinical trial report manuscript and disseminated via peer-reviewed journals (on-line or in press) and presented at national and international conferences.<\/jats:p><jats:p><jats:bold>Trial registration number<\/jats:bold><\/jats:p><jats:p>ACTRN12618001638224; pre-results.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2020-045897","type":"journal-article","created":{"date-parts":[[2021,6,23]],"date-time":"2021-06-23T15:37:18Z","timestamp":1624462638000},"page":"e045897","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":9,"title":["Protocol for a randomised controlled trial comparing two CPAP levels to prevent extubation failure in extremely preterm infants"],"prefix":"10.1136","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8518-5988","authenticated-orcid":false,"given":"Anna Madeline","family":"Kidman","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brett James","family":"Manley","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rosemarie Anne","family":"Boland","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9664-4182","authenticated-orcid":false,"given":"Atul","family":"Malhotra","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susan M","family":"Donath","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6742-7314","authenticated-orcid":false,"given":"Peter G","family":"Davis","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Risha","family":"Bhatia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2021,6,23]]},"reference":[{"key":"2024112411554971000_11.6.e045897.1","doi-asserted-by":"publisher","DOI":"10.1159\/000499361"},{"key":"2024112411554971000_11.6.e045897.2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2018.09.062"},{"key":"2024112411554971000_11.6.e045897.3","doi-asserted-by":"publisher","DOI":"10.1016\/j.peds.2017.04.050"},{"key":"2024112411554971000_11.6.e045897.4","doi-asserted-by":"publisher","DOI":"10.4187\/respcare.07928"},{"key":"2024112411554971000_11.6.e045897.5","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1016\/j.jpeds.2016.02.016","article-title":"Extubating extremely preterm infants: predictors of success and outcomes following failure","volume":"173","author":"Manley","year":"2016","journal-title":"J Pediatr"},{"key":"2024112411554971000_11.6.e045897.6","first-page":"CD000143","article-title":"Nasal continuous positive airways pressure immediately after extubation for preventing morbidity in preterm infants","volume":"2","author":"Davis","year":"2003","journal-title":"Cochrane Database Syst Rev"},{"key":"2024112411554971000_11.6.e045897.7","first-page":"9","article-title":"Levels of nasal CPAP applied during the immediate post- extubation phase","volume":"3","author":"Kitsommart","year":"2013","journal-title":"A Randomized Controlled Pilot Trial"},{"key":"2024112411554971000_11.6.e045897.8","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2013.08.040"},{"key":"2024112411554971000_11.6.e045897.9","doi-asserted-by":"crossref","unstructured":"Esquinas AM , Roehr CC , et al . CPAP in Neonates: Current Methods and Further Improvements. In: Fiorentino G , Insalaco G , et al , eds. Noninvasive Ventilation in Sleep Medicine and Pulmonary Critical Care: Critical Analysis of 2018-19 Clinical Trials [Internet. Cham: Springer International Publishing, 2020: 465\u201375. https:\/\/doi.org\/10.1007\/978-3-030-42998-0_51","DOI":"10.1007\/978-3-030-42998-0_51"},{"key":"2024112411554971000_11.6.e045897.10","doi-asserted-by":"crossref","first-page":"26","DOI":"10.31128\/AJGP-04-18-4545","article-title":"Understanding long-term neurodevelopmental outcomes of very and extremely preterm infants: a clinical review","volume":"48","author":"Jois","year":"2019","journal-title":"Aust J Gen Pract"},{"key":"2024112411554971000_11.6.e045897.11","doi-asserted-by":"publisher","DOI":"10.1038\/s41572-019-0127-7"},{"key":"2024112411554971000_11.6.e045897.12","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild-2017-312962"},{"key":"2024112411554971000_11.6.e045897.13","doi-asserted-by":"publisher","DOI":"10.1038\/jp.2009.149"},{"key":"2024112411554971000_11.6.e045897.14","unstructured":"Breathe JA . Baby, breathe!: neonatal intensive care, prematurity, and complicated pregnancies. University of Toronto Press 2020."},{"key":"2024112411554971000_11.6.e045897.15","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.e7586"},{"key":"2024112411554971000_11.6.e045897.16","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2008.08.010"},{"key":"2024112411554971000_11.6.e045897.17","doi-asserted-by":"publisher","DOI":"10.1097\/00000658-197801000-00001"},{"key":"2024112411554971000_11.6.e045897.18","doi-asserted-by":"crossref","first-page":"1663","DOI":"10.1038\/s41372-019-0475-x","article-title":"A predictive model for extubation readiness in extremely preterm infants","volume":"39","author":"Gupta","year":"2019","journal-title":"J Perinatol"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2020-045897","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,24]],"date-time":"2024-11-24T19:57:06Z","timestamp":1732478226000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2020-045897"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,6]]},"references-count":18,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2021,6,23]]},"published-print":{"date-parts":[[2021,6]]}},"alternative-id":["10.1136\/bmjopen-2020-045897"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2020-045897","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,6]]}}}