Dargaville, PA and Kamlin, COF and De Paoli, AG and Carlin, JB and Orsini, F and Soll, RF and Davis, PG, The OPTIMIST-A trial: evaluation of minimally-invasive surfactant therapy in preterm infants 25-28 weeks gestation, BMC Paediatrics, 14, (1) Article 213. ISSN 1471-2431 (2014) [Refereed Article]
Copyright 2014 The Authors-This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), (CC BY 4.0). Which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.
METHODS/DESIGN: This is a multicentre, randomised, masked, controlled trial in preterm infants 25-28 weeks gestation. Infants are eligible if managed on continuous positive airway pressure without prior intubation, and requiring FiO2 ≥ 0.30 at an age ≤6 hours. Randomisation will be to receive exogenous surfactant (200 mg/kg poractant alfa) via the Hobart method, or sham treatment. Infants in both groups will thereafter remain on continuous positive airway pressure unless intubation criteria are reached (FiO2 ≥ 0.45, unremitting apnoea or persistent acidosis). Primary outcome is the composite of death or physiological bronchopulmonary dysplasia, with secondary outcomes including incidence of death; major neonatal morbidities; durations of all modes of respiratory support and hospitalisation; safety of the Hobart method; and outcome at 2 years. A total of 606 infants will be enrolled. The trial will be conducted in >30 centres worldwide, and is expected to be completed by end-2017.
DISCUSSION: Minimally-invasive surfactant therapy has the potential to ease the burden of respiratory morbidity in preterm infants. The trial will provide definitive evidence on the effectiveness of this approach in the care of preterm infants born at 25-28 weeks gestation.
|Item Type:||Refereed Article|
|Keywords:||Bronchopulmonary dysplasia; Continuous positive airway pressure; Infant; Preterm; Pulmonary surfactants; Respiratory distress syndrome|
|Research Division:||Biomedical and Clinical Sciences|
|Research Field:||Paediatrics not elsewhere classified|
|Objective Group:||Clinical health|
|Objective Field:||Clinical health not elsewhere classified|
|UTAS Author:||Dargaville, PA (Professor Peter Dargaville)|
|UTAS Author:||De Paoli, AG (Dr Tony De Paoli)|
|Web of Science® Times Cited:||47|
|Deposited By:||Menzies Institute for Medical Research|
|Downloads:||293 View Download Statistics|
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