Evaluating the efficacy of Seattle-PAP for the respiratory support of premature neonates: study protocol for a randomized controlled trial

Autor:	Jeanne C. Balough, Stephen E. Welty, Thomas N. Hansen, Mohannad Moallem, Crystal M Alfred, Charles V. Smith, Randy R. Miller, Michael R. Stenger, Brian K. Rivera, Larissa Stanberry, Allison M. Notestine, Jennifer N. Cooper, Christopher R A Howard, Carl H. Backes, Jennifer L. Notestine, Apurwa Naik, John A.F. Zupancic, Juli M. Kern, Jane M. Lamp, Noah H. Hillman
Jazyk:	angličtina
Rok vydání:	2019
Předmět:	Time Factors medicine.medical_treatment Cost-Benefit Analysis Medicine (miscellaneous) Costs analysis law.invention Study Protocol 0302 clinical medicine Neonate Randomized controlled trial law Intubation Birth Weight Infant Very Low Birth Weight Multicenter Studies as Topic Pharmacology (medical) 030212 general & internal medicine Continuous positive airway pressure Respiratory system Lung Randomized Controlled Trials as Topic lcsh:R5-920 Continuous Positive Airway Pressure Respiration Health Care Costs Treatment Outcome Gestation Premature Birth Continuous positive airway pressure (CPAP) Preterm Infant Respiratory Insufficiency lcsh:Medicine (General) Infant Premature medicine.medical_specialty Gestational Age 03 medical and health sciences medicine Intubation Intratracheal Humans Ohio Mechanical ventilation Protocol (science) Respiratory Distress Syndrome Newborn business.industry Infant Newborn Infant Costs Respiratory failure Emergency medicine business 030217 neurology & neurosurgery
Zdroj:	Trials, Vol 20, Iss 1, Pp 1-10 (2019) Trials
ISSN:	1745-6215
Popis:	Background: At birth, the majority of neonates born at Methods: 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: This trial has been registered with the United States National Library of Medicine (www.clinicaltrials.gov, Trial Identifier #NCT03085329). Registered on 21 March 2017.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::463881a5a4098f5b5de228752f43ed05 http://link.springer.com/article/10.1186/s13063-018-3166-6 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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