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      Short term evaluation of respiratory effort by premature infants supported with bubble nasal continuous airway pressure using Seattle-PAP and a standard bubble device

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          Abstract

          Background

          Almost one million prematurely born infants die annually from respiratory insufficiency, predominantly in countries with limited access to respiratory support for neonates. The primary hypothesis tested in the present study was that a modified device for bubble nasal continuous positive airway pressure (Bn-CPAP) would provide lower work of spontaneous breathing, estimated by esophageal pressure-rate products.

          Methods

          Infants born <32 weeks gestation and stable on Bn-CPAP with FiO 2 <0.30 were studied within 72 h following delivery. Esophageal pressures during spontaneous breathing were measured during 2 h on standard Bn-CPAP, then 2 h with Bn-CPAP using a modified bubble device presently termed Seattle-PAP, which produces a different pattern of pressure fluctuations and which provided greater respiratory support in preclinical studies, then 2 h on standard Bn-CPAP.

          Results

          All 40 infants enrolled completed the study and follow-up through 36 wks post menstrual age or hospital discharge, whichever came first. No infants were on supplemental oxygen at completion of follow-up. No infants developed pneumothoraces or nasal trauma, and no adverse events attributed to the study were observed. Pressure-rate products on the two devices were not different, but effort of breathing, assessed by areas under esophageal pressure-time curves, was lower with Seattle-PAP than with standard Bn-CPAP.

          Conclusion

          Use of Seattle-PAP to implement Bn-CPAP lowers the effort of breathing exerted even by relatively healthy spontaneously breathing premature neonates. Whether the lower effort of breathing observed with Seattle-PAP translates to improvements in neonatal mortality or morbidity will need to be determined by studies in appropriate patient populations.

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          Most cited references35

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          Akaike's information criterion in generalized estimating equations.

          W. Pan (2001)
          Correlated response data are common in biomedical studies. Regression analysis based on the generalized estimating equations (GEE) is an increasingly important method for such data. However, there seem to be few model-selection criteria available in GEE. The well-known Akaike Information Criterion (AIC) cannot be directly applied since AIC is based on maximum likelihood estimation while GEE is nonlikelihood based. We propose a modification to AIC, where the likelihood is replaced by the quasi-likelihood and a proper adjustment is made for the penalty term. Its performance is investigated through simulation studies. For illustration, the method is applied to a real data set.
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            Respiratory support in preterm infants at birth.

            (2014)
            Current practice guidelines recommend administration of surfactant at or soon after birth in preterm infants with respiratory distress syndrome. However, recent multicenter randomized controlled trials indicate that early use of continuous positive airway pressure with subsequent selective surfactant administration in extremely preterm infants results in lower rates of bronchopulmonary dysplasia/death when compared with treatment with prophylactic or early surfactant therapy. Continuous positive airway pressure started at or soon after birth with subsequent selective surfactant administration may be considered as an alternative to routine intubation with prophylactic or early surfactant administration in preterm infants.
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              Prophylactic nasal continuous positive airway pressure for preventing morbidity and mortality in very preterm infants.

              Cohort studies have suggested that nasal continuous positive airways pressure (CPAP) starting in the immediate postnatal period before the onset of respiratory disease (prophylactic CPAP) may be beneficial in reducing the need for intubation and intermittent positive pressure ventilation (IPPV) and in preventing bronchopulmonary dysplasia (BPD) in preterm or low birth weight infants.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: VisualizationRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SoftwareRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: SoftwareRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: ResourcesRole: SupervisionRole: ValidationRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: ResourcesRole: SupervisionRole: Writing – review & editing
                Role: Data curationRole: Formal analysisRole: MethodologyRole: ResourcesRole: SoftwareRole: ValidationRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: MethodologyRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SoftwareRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SoftwareRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SoftwareRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                28 March 2018
                2018
                : 13
                : 3
                : e0193807
                Affiliations
                [1 ] Department of Pediatrics, The University of Washington College of Medicine, Seattle, Washington, United States of America
                [2 ] Department of Pediatrics, Baylor College of Medicine, Houston, Texas, United States of America
                [3 ] Center for Developmental Therapeutics, Department of Pediatrics, Seattle Children’s Research Institute, Seattle, Washington, United States of America
                [4 ] Department of Pediatrics West Virginia University School of Medicine, Morgantown, West Virginia, United States of America
                [5 ] Department of Pediatrics and Center for Perinatal Research, the Ohio State University College of Medicine and School of Public Health, Columbus, Ohio, United States of America
                TNO, NETHERLANDS
                Author notes

                Competing Interests: CPR, TNH, and CVS are among the inventors on patents on the Seattle-PAP device and are committed to the Global Access Policy ( http://globalaccess.gatesfoundation.org/) of The Bill & Melinda Gates Foundation, which is directed at ensuring access to the product and technology in very low resource settings, as in low and middle income countries. No other authors identify any potentially competing interests. CPR, TNH, and CVS are among the holders of patents on the Seattle-PAP device, specifically US Patent 8499759, which is readily available online, such as through Google, and several non-US applications and issues of the same intellectual property (IP). All are committed, both personally and formally, to the Global Access Policy ( http://globalaccess.gatesfoundation.org/) of The Bill & Melinda Gates Foundation, which is directed at ensuring access to the product and technology in very low resource settings, as in low and middle income countries. No other authors identify any potentially competing interests. The authors have no consultancy arrangements or products in development. The three authors who are inventors of the patented device do not anticipate receiving any money for holding the patents. This situation is in part the consequence of our stated and agreed-upon commitment to the Global Access Policy of the Bill & Melinda Gates Foundation, which funded the work to develop Seattle-PAP. Other patents: BROAD-BAND, LOW FREQUENCY, HIGH-AMPLITUDE, LONG TIME DURATION, OSCILLATING AIRWAY PRESSURE BREATHING APPARATUS AND METHOD UTILIZING BUBBLES; Issued: February 26, 2013; European Letters Patent No. 2303373. Title: BROAD-BAND, LOW FREQUENCY, HIGH-AMPLITUDE, LONG TIME DURATION, OSCILLATING AIRWAY PRESSURE BREATHING APPARATUS UTILIZING BUBBLES; Issued: July 31, 2013; Issuance of Korea Letters Patent No. 10-1540948. Title: BROAD-BAND, LOW FREQUENCY, HIGH-AMPLITUDE, LONG TIME DURATION, OSCILLATING AIRWAY PRESSURE BREATHING APPARATUS AND METHOD UTILIZING BUBBLES; Filing Date: April 8, 2009; Issuance of New Zealand Letters Patent No. 588682. Title: MECHANICAL VENTILATOR USING TUBE DEPTHS IN WATER TO CONTROL AIRWAY PRESSURE AND BUBBLES TO ADD OSCILLATIONS IN AIRWAY PRESSURE; Issued: October 8, 2012; Australia Patent Application No. 2010241205. Title: BROAD-BAND, LOW FREQUENCY, HIGH-AMPLITUDE, LONG TIME DURATION, OSCILLATING AIRWAY PRESSURE BREATHING APPARATUS AND METHOD UTILIZING BUBBLES; Filed: April 8, 2009; Re: Issuance of Chinese Letters Patent No. 201310269076.X. Title: BROAD-BAND, LOW FREQUENCY, HIGH-AMPLITUDE, LONG TIME DURATION, OSCILLATING AIRWAY PRESSURE BREATHING APPARATUS AND METHOD UTILIZING BUBBLES; Issued: October 28, 2015; Canadian Patent Application No.: 2,720,976. Title: BROAD-BAND, LOW FREQUENCY, HIGH-AMPLITUDE, LONG TIME DURATION, OSCILLATING AIRWAY PRESSURE BREATHING APPARATUS AND METHOD UTILIZING BUBBLES; Re: Issuance of Vietnamese Letters Patent No. 13,756. Title: BROAD-BAND, LOW FREQUENCY, HIGH-AMPLITUDE, LONG TIME DURATION, OSCILLATING AIRWAY PRESSURE BREATHING APPARATUS AND METHOD UTILIZING BUBBLES; Issued: February 9, 2015. Title: BROAD-BAND, LOW FREQUENCY, HIGH-AMPLITUDE, LONG TIME DURATION, OSCILLATING AIRWAY PRESSURE BREATHING APPARATUS AND METHOD UTILIZING BUBBLES; Indian Patent Application No.: 7898/DELNP/2010; Filing Date: April 8, 2009. This does not alter our adherence to PLOS ONE policies on sharing data and materials as detailed online in the guide for authors.

                Author information
                http://orcid.org/0000-0003-4759-9623
                Article
                PONE-D-17-05426
                10.1371/journal.pone.0193807
                5874011
                29590143
                f43a4fb2-157a-40b3-8706-73f0c4be45a4
                © 2018 Welty et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 2 March 2017
                : 18 February 2018
                Page count
                Figures: 7, Tables: 5, Pages: 21
                Funding
                Funded by: funder-id http://dx.doi.org/10.13039/100000865, Bill and Melinda Gates Foundation;
                Award ID: OPP1094124
                Award Recipient :
                Funded by: funder-id http://dx.doi.org/10.13039/100000865, Bill and Melinda Gates Foundation;
                Award ID: OPP1094124
                Award Recipient :
                The work described was supported by OPP1094124 (TNH, CVS) from The Bill & Melinda Gates Foundation ( www.gatesfoundation.org). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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                Custom metadata
                All relevant data are available at the Figshare repository at the following URL: https://doi.org/10.6084/m9.figshare.5031413.v1. Data are also available from Globus sharing services from the Seattle-PAP shared endpoint: https://www.globus.org/app/transfer?origin_id=e1c6b3d9-6d04-11e5-ba46-22000b92c6ec&origin_path=%2Fopt%2Fglobusdata%2Fla-lstanb%2F&destination_id=38aedcec-9f95-11e6-b0dd-22000b92c261.

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