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      Effects of a valved infant-bottle with ergonomic teat on the coordination of sucking, swallowing, and respiration in late-preterm infants. The Safe Oral Feeding randomized Trial

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          Abstract

          Introduction

          Breastfeeding naturally enables the coordination of sucking, swallowing, and respiration patterns for safe feeding. When breastfeeding is not possible a feeding device that releases milk in response to intra-oral vacuum could potentially offer improved coordination of sucking, swallowing, and breathing patterns compared to conventional devices. The aim of the study is to evaluate the effect of a valved infant-bottle with an ergonomic teat compared to a standard infant-bottle.

          Methods

          This unblinded randomized controlled trial focused on late preterm infants fed by bottle for at least three meals over the day, admitted to the Neonatal Unit of Sant’Anna Hospital (Turin, Italy). Infants were randomized to be fed with a valved infant-bottle with an ergonomic teat (B-EXP arm) or with a standard infant-bottle (B-STD arm). Monitoring included a simultaneous synchronized recording of sucking, swallowing and respiration. The main outcome was the swallowing/breathing ratio.

          Results

          Forty infants (20 B-EXP arm; 20 B-STD arm) with a median gestational age of 35.0 weeks (IQR 35.0–36.0 weeks) completed the study. Four infants were censored for the presence of artifacts in the polygraphic traces. The median swallowing/breathing ratio was 1.11 (1.03–1.23) in the B-EXP arm and 1.75 (1.21–2.06) in the B-STD ( p = .003). A lower frequency of swallowing events during the inspiratory phase of breathing was observed in B-EXP arm compared with B-STD arm ( p = 0.013).

          Discussion

          The valved infant-bottle with an ergonomic teat improves the coordination of sucking-swallowing-respiration and limits the risk of inhalation reducing the frequency of swallowing during the inspiratory phase.

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          Most cited references21

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          CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

          The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience
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            Neonatal anthropometric charts: the Italian neonatal study compared with other European studies.

            This was a nationwide prospective study carried out in Italy between 2005 and 2007, involving 34 centers with a neonatal intensive care unit. The study reports the Italian Neonatal Study charts for weight, length, and head circumference of singletons born between 23 and 42 gestational weeks, comparing them with previous Italian data and with the most recent data from European countries. Single live born babies with ultrasound assessment of gestational age within the first trimester, and with both parents of Italian origin. Only fetal hydrops and major congenital anomalies diagnosed at birth were excluded. The reference set consists of 22,087 girls and 23,375 boys. At each gestational age, boys are heavier than girls by about 4%. Later-born neonates are heavier than firstborn neonates by about 3%. The effects of sex and birth order on length and head circumference are milder. No differences were observed between babies born in central-north Italy and southern Italy. A large variability emerged among European neonatal charts, resulting in huge differences in the percentage of Italian Neonatal Study neonates below the 10th centile, which is traditionally used to define small-for-gestational-age babies. In the last 2 decades prominent changes in the distribution of birth weight emerged in Italy and in the rest of Europe, in both term and preterm neonates. The existing European neonatal charts, based on more or less recent data, were found to be inappropriate for Italy. Until an international standard is developed, the use of national updated reference charts is recommended.
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              The maturation and coordination of sucking, swallowing, and respiration in preterm infants.

              Our objectives were to establish normative maturational data for feeding behavior of preterm infants from 32 to 36 weeks of postconception and to evaluate how the relation between swallowing and respiration changes with maturation. Twenty-four infants (28 to 31 weeks of gestation at birth) without complications or defects were studied weekly between 32 and 36 weeks after conception. During bottle feeding with milk flowing only when infants were sucking, sucking efficiency, pressure, frequency, and duration were measured and the respiratory phase in which swallowing occurs was also analyzed. Statistical analysis was performed by repeated-measures analysis of variance with post hoc analysis. The sucking efficiency significantly increased between 34 and 36 weeks after conception and exceeded 7 mL/min at 35 weeks. There were significant increases in sucking pressure and frequency as well as in duration between 33 and 36 weeks. Although swallowing occurred mostly during pauses in respiration at 32 and 33 weeks, after 35 weeks swallowing usually occurred at the end of inspiration. Feeding behavior in premature infants matured significantly between 33 and 36 weeks after conception, and swallowing infrequently interrupted respiration during feeding after 35 weeks after conception.
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                Author and article information

                Contributors
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                Journal
                Front Pediatr
                Front Pediatr
                Front. Pediatr.
                Frontiers in Pediatrics
                Frontiers Media S.A.
                2296-2360
                11 January 2024
                2024
                : 12
                : 1309923
                Affiliations
                [ 1 ]Neonatal Intensive Care Unit, Department of Public Health and Pediatrics, University of Turin , Turin, Italy
                [ 2 ]Department of Obsterics and Gynecology, Città Della Salute e Della Scienza di Torino , Turin, Italy
                Author notes

                Edited by: Isadora Beghetti, University of Bologna, Italy

                Reviewed by: Chantal Lau, Baylor College of Medicine, United States

                Ranjith Kamity, New York University, United States

                [* ] Correspondence: Francesco Cresi francesco.cresi@ 123456unito.it
                [ † ]

                These authors have contributed equally to this work and share first authorship

                Abbreviations B-EXP, experimental valved infant-bottle; B-STD, standard infant-bottle; E-Sw, swallowing events during expiration; I-Sw, swallowing events during inspiration; P-Sw, swallowing events during respiratory pause; RCT, randomized controlled trial; SOFT, Safe Oral Feeding Randomized Trial.

                Article
                10.3389/fped.2024.1309923
                10808751
                29222a79-177f-4020-b75a-eea216e50535
                © 2024 Cresi, Maggiora, Capitanio, Bovio, Borla, Cosimi, Enrietti, Faggiano, Loro, Rovei, Runfola, Scrufari, Taglianti, Vignali, Peila and Coscia.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 08 October 2023
                : 02 January 2024
                Page count
                Figures: 4, Tables: 2, Equations: 0, References: 21, Pages: 0, Words: 0
                Funding
                Funded by: Department of Sciences of Public Health and Pediatrics, University of Turin, Italy
                Award ID:  
                The author(s) declare financial support was received for the research, authorship, and/or publication of this article.
                Artsana s.p.a. (Italy) supported the study with an unrestricted research grant to the Department of Sciences of Public Health and Pediatrics, University of Turin, Italy.
                Categories
                Pediatrics
                Original Research
                Custom metadata
                Neonatology

                oral feeding,bottle,cardiorespiratory events,sucking behaviour,feeding behaviour,feeding skills

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