17
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Patterned frequency-modulated oral stimulation in preterm infants: A multicenter randomized controlled trial

      research-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Objective

          To evaluate the effect of patterned, frequency-modulated oro-somatosensory stimulation on time to full oral feeds in preterm infants born 26–30 weeks gestation.

          Study design

          This is a multicenter randomized controlled trial. The experimental group (n = 109) received patterned, frequency-modulated oral stimulation via the NTrainer system through a pulsatile pacifier and the control group (n = 101) received a non-pulsatile pacifier. Intent-to-treat analysis (n = 210) was performed to compare the experimental and control groups and the outcomes were analyzed using generalized estimating equations. Time-to-event analyses for time to reach full oral feeds and length of hospital stay were conducted using Cox proportional hazards models.

          Results

          The experimental group had reduction in time to full oral feeds compared to the control group (-4.1 days, HR 1.37 (1.03, 1.82) p = 0.03). In the 29–30 weeks subgroup, infants in the experimental group had a significant reduction in time to discharge (-10 days, HR 1.87 (1.23, 2.84) p < 0.01). This difference was not observed in the 26–28 weeks subgroup. There was no difference in growth, mortality or morbidities between the two groups.

          Conclusions

          Patterned, frequency-modulated oro-somatosensory stimulation improves feeding development in premature infants and reduces their length of hospitalization.

          Trial registration

          ClinicalTrials.gov NCT01158391

          Related collections

          Most cited references67

          • Record: found
          • Abstract: found
          • Article: not found

          Target ranges of oxygen saturation in extremely preterm infants.

          Previous studies have suggested that the incidence of retinopathy is lower in preterm infants with exposure to reduced levels of oxygenation than in those exposed to higher levels of oxygenation. However, it is unclear what range of oxygen saturation is appropriate to minimize retinopathy without increasing adverse outcomes. We performed a randomized trial with a 2-by-2 factorial design to compare target ranges of oxygen saturation of 85 to 89% or 91 to 95% among 1316 infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. The primary outcome was a composite of severe retinopathy of prematurity (defined as the presence of threshold retinopathy, the need for surgical ophthalmologic intervention, or the use of bevacizumab), death before discharge from the hospital, or both. All infants were also randomly assigned to continuous positive airway pressure or intubation and surfactant. The rates of severe retinopathy or death did not differ significantly between the lower-oxygen-saturation group and the higher-oxygen-saturation group (28.3% and 32.1%, respectively; relative risk with lower oxygen saturation, 0.90; 95% confidence interval [CI], 0.76 to 1.06; P=0.21). Death before discharge occurred more frequently in the lower-oxygen-saturation group (in 19.9% of infants vs. 16.2%; relative risk, 1.27; 95% CI, 1.01 to 1.60; P=0.04), whereas severe retinopathy among survivors occurred less often in this group (8.6% vs. 17.9%; relative risk, 0.52; 95% CI, 0.37 to 0.73; P<0.001). There were no significant differences in the rates of other adverse events. A lower target range of oxygenation (85 to 89%), as compared with a higher range (91 to 95%), did not significantly decrease the composite outcome of severe retinopathy or death, but it resulted in an increase in mortality and a substantial decrease in severe retinopathy among survivors. The increase in mortality is a major concern, since a lower target range of oxygen saturation is increasingly being advocated to prevent retinopathy of prematurity. (ClinicalTrials.gov number, NCT00233324.) 2010 Massachusetts Medical Society
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Hospital discharge of the high-risk neonate.

            (2008)
            This policy statement updates the guidelines on discharge of the high-risk neonate first published by the American Academy of Pediatrics in 1998. As with the earlier document, this statement is based, insofar as possible, on published, scientifically derived information. This updated statement incorporates new knowledge about risks and medical care of the high-risk neonate, the timing of discharge, and planning for care after discharge. It also refers to other American Academy of Pediatrics publications that are relevant to these issues. This statement draws on the previous classification of high-risk infants into 4 categories: (1) the preterm infant; (2) the infant with special health care needs or dependence on technology; (3) the infant at risk because of family issues; and (4) the infant with anticipated early death. The issues of deciding when discharge is appropriate, defining the specific needs for follow-up care, and the process of detailed discharge planning are addressed as they apply in general to all 4 categories; in addition, special attention is directed to the particular issues presented by the 4 individual categories. Recommendations are given to aid in deciding when discharge is appropriate and to ensure that all necessary care will be available and well coordinated after discharge. The need for individualized planning and physician judgment is emphasized.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Calculating Postnatal Growth Velocity in Very Low Birth Weight (VLBW) Premature Infants

              Objective Currently, there is no standardized approach to the calculation of growth velocity (GV; g/kg/day) in hospitalized very low birth weight (VLBW) infants. Thus, differing methods are used to estimate GV, resulting in different medical centers and studies reporting growth results that are difficult to compare. The objective of this study was to compare actual GV calculated from infant daily weights during hospitalization in a Neonatal Intensive Care Unit (NICU) with estimated GV using two mathematical models that have previously been shown to provide good estimated GVs in extremely low birth weight infants: an exponential model (EM) and a 2-Point model (2-PM). Study Design Daily weights from 81 infants with birth weights of 1000–1499g were used to calculate actual GV in daily increments from two starting points: (1) birth and (2) day of life of regaining birth weight. These daily GV values were then averaged over the NICU stay to yield overall NICU GV from the two starting points. We compared these actual GV with estimated GV calculated using the EM and 2-PM methods. Results The mean absolute difference between actual and EM estimates of GV demonstrated <1% error for 100% of infants from both starting points. The mean absolute difference between actual and 2-PM estimates demonstrated <1% error for only 38% and 44% of infants from birth and regaining birth weight, respectively. The EM was unaffected by decreasing BW and increasing length of NICU stay, while the accuracy of the 2-PM was diminished significantly (p<.001) by both factors. Conclusions In contrast to the 2-PM, the EM provides an extremely accurate estimate of growth velocity in larger VLBW infants, and its accuracy is unaffected by common infant factors. The EM has now been validated for use in all VLBW infants to assess growth and provides a simple-to-use and consistent approach.
                Bookmark

                Author and article information

                Contributors
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: Project administrationRole: SupervisionRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: InvestigationRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: InvestigationRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: InvestigationRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: InvestigationRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: Data curationRole: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: Formal analysisRole: Writing – review & editing
                Role: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: Project administrationRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: InvestigationRole: MethodologyRole: Project administrationRole: SupervisionRole: 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 February 2019
                2019
                : 14
                : 2
                : e0212675
                Affiliations
                [1 ] Pediatrics—Neonatology, Santa Clara Valley Medical Center, San Jose, CA, United States of America
                [2 ] Stanford University School of Medicine, Palo Alto, CA, United States of America
                [3 ] Pediatrics—Neonatology, Children's Hospital at Montefiore-Weiler Division, Albert Einstein College of Medicine, Bronx, NY, United States of America
                [4 ] Pediatrix Medical Group, North Central Baptist Hospital, San Antonio, TX, United States of America
                [5 ] Pediatrics–Neonatology, Baylor College of Medicine, San Antonio, TX, United States of America
                [6 ] Pediatrics–Neonatology, Cook Children's Medical Center, Fort Worth, TX, United States of America
                [7 ] Pediatrics–Neonatology, Children's Hospital at Montefiore-Wakefield Division, Albert Einstein College of Medicine, Bronx, NY, United States of America
                [8 ] aVenture Consulting, LLC, Leawood, KS, United States of America
                [9 ] Neonatology, Montefiore Medical Center-Weiler, Bronx, New York, United States of America
                [10 ] Neonatology, Montefiore Medical Center-Wakefield, Bronx, New York, United States of America
                KU Leuven, BELGIUM
                Author notes

                Competing Interests: DT was an employee of Innara Health, Inc. during the second half of the study period. DT coordinated the clinical trial conducted at the five participating centers, monitored the progress of the study and critically reviewed the manuscript. The other authors have no conflicts of interest to disclose. DT is an employee of a Venture consulting LLC. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

                Author information
                http://orcid.org/0000-0002-5970-6791
                http://orcid.org/0000-0001-8769-2369
                Article
                PONE-D-18-23685
                10.1371/journal.pone.0212675
                6394921
                30817764
                681f1c22-e2dd-4250-835f-ae7f54bd0539
                © 2019 Song 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
                : 22 August 2018
                : 30 January 2019
                Page count
                Figures: 4, Tables: 3, Pages: 15
                Funding
                This study was sponsored by Innara Health Inc., Olathe, Kansas, United States, http://www.innarahealth.com/. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
                Categories
                Research Article
                People and Places
                Population Groupings
                Age Groups
                Children
                Infants
                People and Places
                Population Groupings
                Families
                Children
                Infants
                Medicine and Health Sciences
                Pediatrics
                Medicine and Health Sciences
                Women's Health
                Maternal Health
                Breast Feeding
                Medicine and Health Sciences
                Pediatrics
                Neonatology
                Breast Feeding
                Biology and Life Sciences
                Physiology
                Respiratory Physiology
                Medicine and Health Sciences
                Physiology
                Respiratory Physiology
                Biology and Life Sciences
                Physiology
                Physiological Processes
                Ingestion
                Swallowing
                Medicine and Health Sciences
                Physiology
                Physiological Processes
                Ingestion
                Swallowing
                Medicine and Health Sciences
                Clinical Medicine
                Clinical Trials
                Randomized Controlled Trials
                Medicine and Health Sciences
                Pharmacology
                Drug Research and Development
                Clinical Trials
                Randomized Controlled Trials
                Research and Analysis Methods
                Clinical Trials
                Randomized Controlled Trials
                Medicine and Health Sciences
                Health Care
                Health Statistics
                Morbidity
                People and Places
                Population Groupings
                Professions
                Medical Personnel
                Nurses
                Medicine and Health Sciences
                Health Care
                Health Care Providers
                Nurses
                Custom metadata
                All relevant data is available from the Dryad database (DOI: 10.5061/dryad.rg57q6m).

                Uncategorized
                Uncategorized

                Comments

                Comment on this article