title: Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Extremely preterm infants require assistance recruiting the lung to establish a functional residual capacity after birth. Sustained inflation (SI) combined with positive end expiratory pressure (PEEP) may be a superior method of aerating the lung compared with intermittent positive pressure ventilation (IPPV) with PEEP in extremely preterm infants. The Sustained Aeration of Infant Lungs (SAIL) trial was designed to study this question.
  
  
  METHODS
  This multisite prospective randomized controlled unblinded trial will recruit 600 infants of 23 to 26 weeks gestational age who require respiratory support at birth. Infants in both arms will be treated with PEEP 5 to 7 cm H2O throughout the resuscitation. The study intervention consists of performing an initial SI (20 cm H20 for 15 seconds) followed by a second SI (25 cm H2O for 15 seconds), and then PEEP with or without IPPV, as needed. The control group will be treated with initial IPPV with PEEP. The primary outcome is the combined endpoint of bronchopulmonary dysplasia or death at 36 weeks post-menstrual age.
  
  
  BACKGROUND
  www.clinicaltrials.gov , Trial identifier NCT02139800 , Registered 13 May 2014.
authors: Division of Neonatology, The Children's Hospital of Philadelphia, 34th and Civic Center Blvd., 2nd Floor Main Building, Philadelphia, PA, 19104, USA. foglia@email.chop.edu.|Department of Pediatrics, University of Pennsylvania Perelman School of Medicine, 34th and Civic Center Blvd, Philadelphia, PA, 19104, USA. foglia@email.chop.edu.
authors: Elizabeth E
authors: EE
authors: Foglia
authors: Department of Newborn Research, Royal Women's Hospital, 20 Flemington Road, Parkville, VIC, 3052, Australia. Louise.Owen@thewomens.org.au.|University of Melbourne, Grattan Street, Parkville, VIC, 3010, Australia. Louise.Owen@thewomens.org.au.|Murdoch Children's Research Institute, Royal Children's Hospital, 50 Flemington Road, 9th Floor, Parkville, VIC, 3052, Australia. Louise.Owen@thewomens.org.au.
authors: Louise S
authors: LS
authors: Owen
authors: Department of Newborn Research, Royal Women's Hospital, 20 Flemington Road, Parkville, VIC, 3052, Australia. Marta.ThioLluch@thewomens.org.au.|University of Melbourne, Grattan Street, Parkville, VIC, 3010, Australia. Marta.ThioLluch@thewomens.org.au.|Murdoch Children's Research Institute, Royal Children's Hospital, 50 Flemington Road, 9th Floor, Parkville, VIC, 3052, Australia. Marta.ThioLluch@thewomens.org.au.
authors: Marta
authors: M
authors: Thio
authors: Department of Biostatistics and Epidemiology, University of Pennsylvania Perelman School of Medicine, Blockley Hall, 423 Guardian Dr., Philadelphia, PA, 19104, USA. sratclif@mail.med.upenn.edu.
authors: Sarah J
authors: SJ
authors: Ratcliffe
authors: Division of Neonatology, 'VBuzzi' Children's Hospital, Via Castelvetro 32, 20154, Milan, Italy. gianluca.lista@icp.mi.it.
authors: Gianluca
authors: G
authors: Lista
authors: Division of Neonatology, Department of Pediatrics, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, Netherlands. A.B.te_Pas@lumc.nl.
authors: Arjan
authors: A
authors: Te Pas
authors: Division of Neonatology and Pediatric Critical Care, Department of Pediatrics, Children's Hospital University of Ulm, Eythstrasse 24, Ulm, 89081, Germany. helmut.hummler@uni-ulm.de.
authors: Helmut
authors: H
authors: Hummler
authors: Department of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia, 34th and Civic Center Blvd, 8th Floor Main Building, Philadelphia, PA, 19104, USA. nadkarni@email.chop.edu.
authors: Vinay
authors: V
authors: Nadkarni
authors: Division of Neonatology, The Children's Hospital of Philadelphia, 34th and Civic Center Blvd., 2nd Floor Main Building, Philadelphia, PA, 19104, USA. ades@email.chop.edu.|Department of Pediatrics, University of Pennsylvania Perelman School of Medicine, 34th and Civic Center Blvd, Philadelphia, PA, 19104, USA. ades@email.chop.edu.
authors: Anne
authors: A
authors: Ades
authors: Division of Neonatology, The Children's Hospital of Philadelphia, 34th and Civic Center Blvd., 2nd Floor Main Building, Philadelphia, PA, 19104, USA. Michael.Posencheg@uphs.upenn.edu.|Department of Pediatrics, University of Pennsylvania Perelman School of Medicine, 34th and Civic Center Blvd, Philadelphia, PA, 19104, USA. Michael.Posencheg@uphs.upenn.edu.
authors: Michael
authors: M
authors: Posencheg
authors: Alpert Medical School of Brown University, 222 Richmond St, Providence, RI, 02903, USA. mkeszler@wihri.org.|Division of Neonatology, Women and Infants Hospital of Rhode Island, 101 Dudley Street, Providence, RI, 02905, USA. mkeszler@wihri.org.
authors: Martin
authors: M
authors: Keszler
authors: Department of Newborn Research, Royal Women's Hospital, 20 Flemington Road, Parkville, VIC, 3052, Australia. pgd@unimelb.edu.au.|University of Melbourne, Grattan Street, Parkville, VIC, 3010, Australia. pgd@unimelb.edu.au.|Murdoch Children's Research Institute, Royal Children's Hospital, 50 Flemington Road, 9th Floor, Parkville, VIC, 3052, Australia. pgd@unimelb.edu.au.
authors: Peter
authors: P
authors: Davis
authors: Division of Neonatology, The Children's Hospital of Philadelphia, 34th and Civic Center Blvd., 2nd Floor Main Building, Philadelphia, PA, 19104, USA. kirpalanih@email.chop.edu.|Department of Pediatrics, University of Pennsylvania Perelman School of Medicine, 34th and Civic Center Blvd, Philadelphia, PA, 19104, USA. kirpalanih@email.chop.edu.
authors: Haresh
authors: H
authors: Kirpalani
mesh_terms: D001315:Australia; D001997:Bronchopulmonary Dysplasia / Q000209:etiology; D002170:Canada; D002985:Clinical Protocols; D005060:Europe; D005865:Gestational Age; D006801:Humans; D062071:Infant, Extremely Premature; D007231:Infant, Newborn; D007385:Intermittent Positive-Pressure Ventilation / Q000009:adverse effects / Q000401:mortality; D008168:Lung / Q000503:physiopathology*; D011175:Positive-Pressure Respiration / Q000009:adverse effects / Q000401:mortality; D011446:Prospective Studies; D012107:Research Design; D012127:Respiratory Distress Syndrome, Newborn / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States