We determined changes in functional feeding skills and growth after one year of intraoral appliance therapy in dysphagic children. Twenty children, 4.2-13.1 years of age (average 8.3 +/- 0.9 years), participated in this study. Children wore the appliance daily. Phase I of treatment (6 months) aimed primarily at stabilizing the mandible and phase II aimed at facilitating ingestive skills. A control period of 6 months preceded treatment. Functional feeding skills improved significantly during phase I beyond changes seen during the control period. Further significant improvement occurred in chewing during phase II. All children significantly gained weight (kg) during the control period, as well as during the two treatment phases. This weight gain was sufficient for children to maintain their growth trajectory. There was also significant growth in height (cm). This growth spurt was characterized by marginal catch-up. Jaw stabilization was a major contributor to the significant improvement in functional feeding skills. Weight gain cannot be attributed to intervention because it occurred during the control period and was the same in magnitude through both treatment phases. However, it permitted a period of growth in stature which previously had been described only after tube feeding.
BACKGROUND Trauma-induced coagulopathy (TIC) substantially contributes to mortality in bleeding trauma patients. OBJECTIVE The aim of the study was to administer fibrinogen concentrate in the prehospital setting to improve blood clot stability in trauma patients bleeding or presumed to bleed. DESIGN A prospective, randomised, placebo-controlled, double-blinded, international clinical trial. SETTING This emergency care trial was conducted in 12 Helicopter Emergency Medical Services (HEMS) and Emergency Doctors’ vehicles (NEF or NAW) and four trauma centres in Austria, Germany and Czech Republic between 2011 and 2015. PATIENTS A total of 53 evaluable trauma patients aged at least 18 years with major bleeding and in need of volume therapy were included, of whom 28 received fibrinogen concentrate and 25 received placebo. INTERVENTIONS Patients were allocated to receive either fibrinogen concentrate or placebo prehospital at the scene or during transportation to the study centre. MAIN OUTCOME MEASURES Primary outcome was the assessment of clot stability as reflected by maximum clot firmness in the FIBTEM assay (FIBTEM MCF) before and after administration of the study drug. RESULTS Median FIBTEM MCF decreased in the placebo group between baseline (before administration of study treatment) and admission to the Emergency Department, from a median of 12.5 [IQR 10.5 to 14] mm to 11 [9.5 to 13] mm ( P = 0.0226), but increased in the FC Group from 13 [11 to 15] mm to 15 [13.5 to 17] mm ( P = 0.0062). The median between-group difference in the change in FIBTEM MCF was 5 [3 to 7] mm ( P < 0.0001). Median fibrinogen plasma concentrations in the fibrinogen concentrate Group were kept above the recommended critical threshold of 2.0 g l −1 throughout the observation period. CONCLUSION Early fibrinogen concentrate administration is feasible in the complex and time-sensitive environment of prehospital trauma care. It protects against early fibrinogen depletion, and promotes rapid blood clot initiation and clot stability. TRIAL REGISTRY NUMBERS EudraCT: 2010-022923-31 and ClinicalTrials.gov: NCT01475344.
To determine the impact of intraoral appliance (ISMAR) therapy on functional feeding skills and growth, children with cerebral palsy and moderate dysphagia were followed a full year after termination of one year of ISMAR therapy. Seventeen children, 6.6-15.4 years old (mean age = 10.2 +/- 3.0 years), were divided into two groups: group A (n = 9) continued to wear the appliance and group B (n = 8) no longer wore the appliance. Generalized estimating equations (GEE) were used to test differences between the two groups over time while accounting for the dependence for the repeated within-subject measurements. No significant differences were found in the 7 domains of functional feeding. Significant time x group interactions for weight (kg and z-score 0.01 < p < 0.05) were found. However, post hoc analyses showed that there were no significant differences in weight changes between the two groups at either 18 or 24 months of followup. These results suggest that during a one-year period of followup, maturation was equally effective as ISMAR therapy.
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