Trials · 2019
Evaluating the efficacy of Seattle-PAP for the respiratory support of premature neonates: study protocol for a randomized controlled trial.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Ошибки и ограничения
История · было → стало
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Backes Carl H, Notestine Jennifer L, Lamp Jane M, Balough Jeanne C, Notestine Allison M, Alfred Crystal M, Kern Juli M, Stenger Michael R, Rivera Brian K, Moallem Mohannad, Miller Randy R, Naik Apurwa, Cooper Jennifer N, Howard Christopher R, Welty Stephen E, Hillman Noah H, Zupancic John A F, Stanberry Larissa I, Hansen Thomas N, Smith Charles V
Аннотация
BACKGROUND: At birth, the majority of neonates born at <30 weeks of gestation require respiratory support to facilitate transition and ensure adequate gas exchange. Although the optimal approach to the initial respiratory management is uncertain, the American Academy of Pediatrics endorses noninvasive respiratory support with nasal continuous positive airway pressure (nCPAP) for premature neonates with respiratory insufficiency. Despite evidence for its use, nCPAP failure, requiring intubation and mechanical ventilation, is common. Recently, investigators have described a novel method to deliver bubble nCPAP, termed Seattle-PAP. While preclinical and pilot studies are encouraging regarding the potential value of Seattle-PAP, a large trial is needed to compare Seattle-PAP directly with the current standard of care for bubble nCPAP (Fisher & Paykel CPAP or FP-CPAP).
METHODS/DESIGN: We designed a multicenter, non-blinded, randomized controlled trial that will enroll 230 premature infants (220/7 to 296/7 weeks of gestation). Infants will be randomized to receive Seattle-PAP or FP-CPAP. The primary outcome is respiratory failure requiring intubation and mechanical ventilation. Secondary outcomes include measures of short- and long-term respiratory morbidity and cost-effectiveness.
DISCUSSION: This trial will assess whether Seattle-PAP is more efficacious and cost-effective than FP-CPAP in real-world practice among premature neonates.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT03085329 . Registered on 21 March 2017.
METHODS/DESIGN: We designed a multicenter, non-blinded, randomized controlled trial that will enroll 230 premature infants (220/7 to 296/7 weeks of gestation). Infants will be randomized to receive Seattle-PAP or FP-CPAP. The primary outcome is respiratory failure requiring intubation and mechanical ventilation. Secondary outcomes include measures of short- and long-term respiratory morbidity and cost-effectiveness.
DISCUSSION: This trial will assess whether Seattle-PAP is more efficacious and cost-effective than FP-CPAP in real-world practice among premature neonates.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT03085329 . Registered on 21 March 2017.
Предметные рубрики MeSH
Birth WeightContinuous Positive Airway PressureCost-Benefit AnalysisGestational AgeHealth Care CostsHumansInfant, NewbornInfant, PrematureInfant, Very Low Birth WeightIntubation, IntratrachealLungMulticenter Studies as TopicOhioPremature BirthRandomized Controlled Trials as TopicRespirationRespiratory Distress Syndrome, NewbornRespiratory InsufficiencyTime FactorsTreatment Outcome