Evidence map›Paper›PMID 25872563›Full record

Trial reportTrials2015

Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial.

Elizabeth E Foglia, Louise S Owen, Marta Thio, Sarah J Ratcliffe, Gianluca Lista, Arjan Te Pas, Helmut Hummler, Vinay Nadkarni, Anne Ades, Michael Posencheg and 3 more

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 19 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 5 pooled it
5.7field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02139800 nacompletednot on this map

Sustained Aeration of Infant Lungs Trial

TypeinterventionalSponsorUniversity of PennsylvaniaRan2014 to 2020Enrolled460ConditionsPreterm Birth, Extreme PrematurityArmsSustained Inflation, Standard of Care
NCT02629887 nawithdrawnnot on this mapstarted 2018, after this paper: background citation

Non-inflatable Supraglottic Airway (NI-SGA) vs. Face Mask (FM) as a Primary Interface Device for Neonatal Resuscitation: A Pilot Study

TypeinterventionalSponsorUniversity of OklahomaRan2018 to 2018Enrolled0ConditionsNeonatal ResuscitationArmsNon-inflatable supraglottic airway, Face Mask, T-Piece Resuscitator
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 5 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Sustained inflations and avoiding mechanical ventilation to prevent death or bronchopulmonary dysplasia: a meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2018
    Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Article
  9. Review
  10. Article
  11. Article
  12. Chest Compressions in the Delivery Room.Children (Basel, Switzerland) · 2019
    Review
  13. Article
  14. Review
  15. Review
  16. Delivery room interventions to prevent bronchopulmonary dysplasia in extremely preterm infants.Journal of perinatology : official journal of the California Perinatal Association · 2017
    Review
  17. Review
  18. Review
  19. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 4 countries.

Elizabeth E FogliaDivision 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.
Louise S OwenDepartment of Newborn Research, Royal Women's Hospital, 20 Flemington Road, Parkville, VIC, 3052, Australia. Louise.Owen@thewomens.org.au.
Marta ThioDepartment of Newborn Research, Royal Women's Hospital, 20 Flemington Road, Parkville, VIC, 3052, Australia. Marta.ThioLluch@thewomens.org.au.
Sarah J RatcliffeDepartment 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.
Gianluca ListaDivision of Neonatology, 'VBuzzi' Children's Hospital, Via Castelvetro 32, 20154, Milan, Italy. gianluca.lista@icp.mi.it.
Arjan Te PasDivision of Neonatology, Department of Pediatrics, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, Netherlands. A.B.te_Pas@lumc.nl.
Helmut HummlerDivision 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.
Vinay NadkarniDepartment 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.
Anne AdesDivision 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.
Michael PosenchegDivision 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.
Martin KeszlerAlpert Medical School of Brown University, 222 Richmond St, Providence, RI, 02903, USA. mkeszler@wihri.org.
Peter DavisDepartment of Newborn Research, Royal Women's Hospital, 20 Flemington Road, Parkville, VIC, 3052, Australia. pgd@unimelb.edu.au.
Haresh KirpalaniDivision 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.
University of Pennsylvania · USChildren's Hospital of Philadelphia · USRoyal Women's Hospital · AUBrown University · USLeiden University Medical Center · NLUniversity Hospital Ulm · DEUniversity of Melbourne · AU

Funding

The SAIL trial [Sustained Aeration of Infant Lungs]U01HD072906 · NICHD · CHILDREN'S HOSP OF PHILADELPHIA · PI KESZLER, MARTIN, KIRPALANI, HARESH · 2013 to 2017
$5.5M
NICHD NIH HHS 1-U01-HD072906-01A1NICHD NIH HHS U01 HD072906
6 · The paper itself

Abstract

backgroundExtremely 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/

designThis 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.

trial registrationwww.clinicaltrials.gov , Trial identifier NCT02139800 , Registered 13 May 2014.

Indexed as

Intermittent Positive-Pressure VentilationPositive-Pressure RespirationAustraliaBronchopulmonary DysplasiaCanadaClinical ProtocolsEuropeGestational AgeHumansInfant, Extremely PrematureInfant, NewbornLungProspective StudiesResearch DesignRespiratory Distress Syndrome, NewbornRisk Factors

Identifiers

PMID25872563
PMCPMC4372179
OpenAlexW2153168199

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.