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

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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/Design

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 H ₂O throughout the resuscitation. The study intervention consists of performing an initial SI (20 cm H ₂0 for 15 seconds) followed by a second SI (25 cm H ₂O 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 Registration

www.clinicaltrials.gov, Trial identifier NCT02139800, Registered 13 May 2014

Electronic supplementary material

The online version of this article (doi:10.1186/s13063-015-0601-9) contains supplementary material, which is available to authorized users.

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Most cited references 29

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Early CPAP versus surfactant in extremely preterm infants.

Neil N Finer, Waldemar A Carlo, Michele C Walsh … (2010)

There are limited data to inform the choice between early treatment with continuous positive airway pressure (CPAP) and early surfactant treatment as the initial support for extremely-low-birth-weight infants. We performed a randomized, multicenter trial, with a 2-by-2 factorial design, involving infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. Infants were randomly assigned to intubation and surfactant treatment (within 1 hour after birth) or to CPAP treatment initiated in the delivery room, with subsequent use of a protocol-driven limited ventilation strategy. Infants were also randomly assigned to one of two target ranges of oxygen saturation. The primary outcome was death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen at 36 weeks (with an attempt at withdrawal of supplemental oxygen in neonates who were receiving less than 30% oxygen). A total of 1316 infants were enrolled in the study. The rates of the primary outcome did not differ significantly between the CPAP group and the surfactant group (47.8% and 51.0%, respectively; relative risk with CPAP, 0.95; 95% confidence interval [CI], 0.85 to 1.05) after adjustment for gestational age, center, and familial clustering. The results were similar when bronchopulmonary dysplasia was defined according to the need for any supplemental oxygen at 36 weeks (rates of primary outcome, 48.7% and 54.1%, respectively; relative risk with CPAP, 0.91; 95% CI, 0.83 to 1.01). Infants who received CPAP treatment, as compared with infants who received surfactant treatment, less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia (P<0.001), required fewer days of mechanical ventilation (P=0.03), and were more likely to be alive and free from the need for mechanical ventilation by day 7 (P=0.01). The rates of other adverse neonatal outcomes did not differ significantly between the two groups. The results of this study support consideration of CPAP as an alternative to intubation and surfactant in preterm infants. (ClinicalTrials.gov number, NCT00233324.) 2010 Massachusetts Medical Society

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Nasal CPAP or intubation at birth for very preterm infants.

Colin Morley, Peter Davis, Lex Doyle … (2008)

Bronchopulmonary dysplasia is associated with ventilation and oxygen treatment. This randomized trial investigated whether nasal continuous positive airway pressure (CPAP), rather than intubation and ventilation, shortly after birth would reduce the rate of death or bronchopulmonary dysplasia in very preterm infants. We randomly assigned 610 infants who were born at 25-to-28-weeks' gestation to CPAP or intubation and ventilation at 5 minutes after birth. We assessed outcomes at 28 days of age, at 36 weeks' gestational age, and before discharge. At 36 weeks' gestational age, 33.9% of 307 infants who were assigned to receive CPAP had died or had bronchopulmonary dysplasia, as compared with 38.9% of 303 infants who were assigned to receive intubation (odds ratio favoring CPAP, 0.80; 95% confidence interval [CI], 0.58 to 1.12; P=0.19). At 28 days, there was a lower risk of death or need for oxygen therapy in the CPAP group than in the intubation group (odds ratio, 0.63; 95% CI, 0.46 to 0.88; P=0.006). There was little difference in overall mortality. In the CPAP group, 46% of infants were intubated during the first 5 days, and the use of surfactant was halved. The incidence of pneumothorax was 9% in the CPAP group, as compared with 3% in the intubation group (P<0.001). There were no other serious adverse events. The CPAP group had fewer days of ventilation. In infants born at 25-to-28-weeks' gestation, early nasal CPAP did not significantly reduce the rate of death or bronchopulmonary dysplasia, as compared with intubation. Even though the CPAP group had more incidences of pneumothorax, fewer infants received oxygen at 28 days, and they had fewer days of ventilation. (Australian New Zealand Clinical Trials Registry number, 12606000258550.). Copyright 2008 Massachusetts Medical Society.

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A multiple testing procedure for clinical trials.

P O'Brien, T Fleming (1979)

A multiple testing procedure is proposed for comparing two treatments when response to treatment is both dichotomous (i.e., success or failure) and immediate. The proposed test statistic for each test is the usual (Pearson) chi-square statistic based on all data collected to that point. The maximum number (N) of tests and the number (m1 + m2) of observations collected between successive tests is fixed in advance. The overall size of the procedure is shown to be controlled with virtually the same accuracy as the single sample chi-square test based on N(m1 + m2) observations. The power is also found to be virtually the same. However, by affording the opportunity to terminate early when one treatment performs markedly better than the other, the multiple testing procedure may eliminate the ethical dilemmas that often accompany clinical trials.

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Author and article information

Contributors

Elizabeth E Foglia: foglia@email.chop.edu

Louise S Owen: Louise.Owen@thewomens.org.au

Marta Thio: Marta.ThioLluch@thewomens.org.au

Sarah J Ratcliffe: sratclif@mail.med.upenn.edu

Gianluca Lista: gianluca.lista@icp.mi.it

Arjan te Pas: A.B.te_Pas@lumc.nl

Helmut Hummler: helmut.hummler@uni-ulm.de

Vinay Nadkarni: nadkarni@email.chop.edu

Anne Ades: ades@email.chop.edu

Michael Posencheg: Michael.Posencheg@uphs.upenn.edu

Martin Keszler: mkeszler@wihri.org

Peter Davis: pgd@unimelb.edu.au

Haresh Kirpalani: kirpalanih@email.chop.edu

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 15 March 2015

Publication date PMC-release: 15 March 2015

Publication date Collection: 2015

Volume: 16

Electronic Location Identifier: 95

Affiliations

[ ]Division of Neonatology, The Children’s Hospital of Philadelphia, 34th and Civic Center Blvd., 2nd Floor Main Building, Philadelphia, PA 19104 USA

[ ]Department of Pediatrics, University of Pennsylvania Perelman School of Medicine, 34th and Civic Center Blvd, Philadelphia, PA 19104 USA

[ ]Department of Newborn Research, Royal Women’s Hospital, 20 Flemington Road, Parkville, VIC 3052 Australia

[ ]University of Melbourne, Grattan Street, Parkville, VIC 3010 Australia

[ ]Murdoch Children’s Research Institute, Royal Children’s Hospital, 50 Flemington Road, 9th Floor, Parkville, VIC 3052 Australia

[ ]Department of Biostatistics and Epidemiology, University of Pennsylvania Perelman School of Medicine, Blockley Hall, 423 Guardian Dr., Philadelphia, PA 19104 USA

[ ]Division of Neonatology, ‘VBuzzi’ Children’s Hospital, Via Castelvetro 32, 20154 Milan, Italy

[ ]Division of Neonatology, Department of Pediatrics, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, Netherlands

[ ]Division of Neonatology and Pediatric Critical Care, Department of Pediatrics, Children’s Hospital University of Ulm, Eythstrasse 24, Ulm, 89081 Germany

[ ]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

[ ]Alpert Medical School of Brown University, 222 Richmond St, Providence, RI 02903 USA

[ ]Division of Neonatology, Women and Infants Hospital of Rhode Island, 101 Dudley Street, Providence, RI 02905 USA

Article

Publisher ID: 601

DOI: 10.1186/s13063-015-0601-9

PMC ID: 4372179

PubMed ID: 25872563

SO-VID: 998008a9-8843-4822-9ac6-0e76c1a6f6ce

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 4 August 2014

Date accepted : 11 February 2015

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: preterm infants,resuscitation,bronchopulmonary dysplasia,sustained inflation,continuous positive airway pressure

Data availability:

ScienceOpen disciplines: Medicine

Keywords: preterm infants, resuscitation, bronchopulmonary dysplasia, sustained inflation, continuous positive airway pressure

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

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Abstract

Background

Methods/Design

Trial Registration

Electronic supplementary material

Related collections

Herbal Medicines Journal (Herb Med J)

Most cited references 29

Early CPAP versus surfactant in extremely preterm infants.

Nasal CPAP or intubation at birth for very preterm infants.

A multiple testing procedure for clinical trials.

Author and article information

Contributors

Journal

Affiliations

Article

History

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