Academic Journal
Intratracheal budesonide mixed with surfactant to increase survival free of bronchopulmonary dysplasia in extremely preterm infants: statistical analysis plan for the international, multicenter, randomized PLUSS trial
| العنوان: | Intratracheal budesonide mixed with surfactant to increase survival free of bronchopulmonary dysplasia in extremely preterm infants: statistical analysis plan for the international, multicenter, randomized PLUSS trial |
|---|---|
| المؤلفون: | Francis, Kate L, McKinlay, Christopher J D, Kamlin, C Omar F, Cheong, Jeanie L Y, Dargaville, Peter A, Dawson, Jennifer A, Doyle, Lex W, Jacobs, Susan E, Davis, Peter G, Donath, Susan M, Manley, Brett J |
| المساهمون: | National Health and Medical Research Council, Chiesi Farmaceutici |
| المصدر: | Trials ; volume 24, issue 1 ; ISSN 1745-6215 |
| بيانات النشر: | Springer Science and Business Media LLC |
| سنة النشر: | 2023 |
| الوصف: | Background Bronchopulmonary dysplasia (BPD), an inflammatory-mediated chronic lung disease, is common in extremely preterm infants born before 28 weeks’ gestation and is associated with an increased risk of adverse neurodevelopmental and respiratory outcomes in childhood. Effective and safe prophylactic therapies for BPD are urgently required. Systemic corticosteroids reduce rates of BPD in the short term but are associated with poorer neurodevelopmental outcomes if given to ventilated infants in the first week after birth. Intratracheal administration of corticosteroid admixed with exogenous surfactant could overcome these concerns by minimizing systemic sequelae. Several small, randomized trials have found intratracheal budesonide in a surfactant vehicle to be a promising therapy to increase survival free of BPD. The primary objective of the PLUSS trial is to determine whether intratracheal budesonide mixed with surfactant increases survival free of bronchopulmonary dysplasia (BPD) at 36 weeks’ postmenstrual age (PMA) in extremely preterm infants born before 28 weeks’ gestation. Methods An international, multicenter, double-blinded, randomized trial of intratracheal budesonide (a corticosteroid) mixed with surfactant for extremely preterm infants to increase survival free of BPD at 36 weeks’ postmenstrual age (PMA; primary outcome). Extremely preterm infants aged < 48 h after birth are eligible if (1) they are mechanically ventilated, or (2) they are receiving non-invasive respiratory support and there is a clinical decision to treat with surfactant. The intervention is budesonide (0.25 mg/kg) mixed with poractant alfa (200 mg/kg first intervention, 100 mg/kg if second intervention), administered intratracheally via an endotracheal tube or thin catheter. The comparator is poractant alfa alone (at the same doses). Secondary outcomes include the components of the primary outcome (death, BPD prior to or at 36 weeks’ PMA), and potential systemic side effects of corticosteroids. Longer-term outcomes ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1186/s13063-023-07650-0 |
| DOI: | 10.1186/s13063-023-07650-0.pdf |
| DOI: | 10.1186/s13063-023-07650-0/fulltext.html |
| الاتاحة: | http://dx.doi.org/10.1186/s13063-023-07650-0 https://link.springer.com/content/pdf/10.1186/s13063-023-07650-0.pdf https://link.springer.com/article/10.1186/s13063-023-07650-0/fulltext.html |
| Rights: | https://creativecommons.org/licenses/by/4.0 ; https://creativecommons.org/licenses/by/4.0 |
| رقم الانضمام: | edsbas.42E035D3 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1186/s13063-023-07650-0 |
|---|