CONTROLLED STUDY OF LINEAR GROWTH IN ASTHMATIC CHILDREN DURING TREATMENT WITH INHALED GLUCOCORTICOSTEROIDS

PEDIATRICS ◽  
1994 ◽  
Vol 94 (2) ◽  
pp. 270-270
Author(s):  
Christopher Randolph
Keyword(s):  
School Children ◽  
Growth Velocity ◽  
Linear Growth ◽  
Lower Leg ◽  
Mild Asthma ◽  
Controlled Study ◽  
Double Blind ◽  
Significant Difference ◽  
Inhaled Budesonide ◽  
The Impact

Purpose of the Study. To determine the impact of short term inhaled budesonide on linear growth in school children with mild asthma. Study Population. Forty-three school children with mild asthma. Methods. A randomized double blind parallel group study with three dose groups of 200, 400, and 800 µg of budesonide per day administered with a 750-mL spacer (Nebuhaler). Each group received budesonide for 8 consecutive weeks. Placebo was given 4 weeks before or after budesonide. Findings. Compared with placebo, children treated with 800 µg of budesonide had a statistically significant lower leg growth velocity by 0.26 mm/week (P < .0012; t = 5.0; df = 11; 95% confidence interval, 0.14 to 0.37 mm/week). There was no statistically significant difference in the growth velocity between 200 or 400 µg of budesonide treatments and placebo. Reviewer's Comments. This study was conducted with knemometry, a method utilized in measuring the length of the lower leg with apparent high reproducibility and accuracy. Unfortunately, the correlation between growth of the lower leg and chronic growth is undear. Several steroid studies in the past have indicated that budesonide up to levels of 800 µg does not interfere with long term growth. Thus, the impact of the study is unclear at present. Clearly, a longer term study is necessary to determine the outcome of these children. Additionally, it would be important to see the impact of budesonide in chronic asthma with greater severity, which itself may interfere with growth.

Controlled Study of Linear Growth in Asthmatic Children During Treatment With Inhaled Glucocorticosteroids

PEDIATRICS ◽  
1992 ◽  
Vol 89 (5) ◽  
pp. 839-842
Author(s):  
Ole D. Wolthers ◽  
Søren Pedersen
Keyword(s):  
Growth Velocity ◽  
Linear Growth ◽  
Placebo Treatment ◽  
Controlled Study ◽  
Group 14 ◽  
Double Blind ◽  
Asthmatic Children ◽  
Parallel Group ◽  
Significant Difference ◽  
Inhaled Budesonide

Linear growth was investigated with weekly knemometry in a population of 43 schoolchildren with mild asthma treated with inhaled budesonide. The design was a randomized, double-blind, parallel group study with three dose groups of 200, 400, and 800 µg of budesonide per day. Each dose group received budesonide for 8 consecutive weeks. Placebo was given for either 4 weeks before or after budesonide treatment. Twelve children in the 200-µg group, 14 in the 400-µg group, and 12 in the 800-µg group completed the 12-week study period. There was no significant difference in mean growth velocity among the three dose groups during placebo treatment. Compared with placebo (growth velocity: 0.39 mm/wk), mean lower leg growth velocity was reduced with 0.26 mm/wk (P < .001, t = 5.0, df = 11; 95% confidence interval 0.14 to 0.37 mm/wk) in children treated with 800 µg of budesonide. There was no statistically significant difference in growth velocity between 200- or 400-µg budesonide treatments and placebo. These data indicate that inhaled budesonide can be safely used in doses up to 400 µg/d in schoolchildren with asthma.

scholarly journals 630. Emergence of Colistin Resistance in the OVERCOME Trial: Impact of Combination Therapy with Meropenem

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S418-S419
Author(s):  
Jason M Pogue ◽  
Michael J Rybak ◽  
Kyle Stamper ◽  
Dror Marchaim ◽  
Visanu Thamlikitkul ◽  
...  
Keyword(s):  
Infection Type ◽  
Therapeutic Option ◽  
Controlled Trial ◽  
Severity Of Illness ◽  
Controlled Study ◽  
Independent Contractor ◽  
Double Blind ◽  
Resistance Development ◽  
Significant Difference ◽  
The Impact

Abstract Background Colistin (COL) remains an important therapeutic option for carbapenem-resistant (CR) Gram-negative bacilli (GNB). COL is often utilized in combination with meropenem (MEM), in part due to concerns regarding the development of COL resistance with monotherapy. We recently completed a randomized controlled trial comparing outcomes in patients receiving COL + placebo to those receiving COL + MEM; herein we present data on the emergence of COL resistance in this trial. Methods OVERCOME was an international, multicenter, randomized, double-blind, placebo-controlled study comparing COL and COL + MEM for the treatment of bloodstream infection and/or pneumonia due to CR GNB. Subjects were included in the modified intent to treat population (mITT) if their enrollment pathogen had a COL MIC ≤2 mg/L, as determined by broth microdilution (BMD). Daily blood and/or respiratory samples were obtained in patients per protocol until two consecutive negatives were obtained or the end of study treatment. All subsequent isolates were evaluated for COL resistance via BMD, defined as MIC ≥ 4 mg/L. Results Of the 425 patients in the mITT population, 380 (191 COL; 189 COL + MEM) were evaluable for the endpoint of COL resistance development. The median age of the cohort was 70, 38% were female, 47% were white, and 45% were Asian. 70% had an index infection of pneumonia, 68% were in the intensive care unit at the onset of their infection, and A. baumannii was the most common pathogen (78% of patients). Baseline characteristics, infection type, severity of illness, and index pathogen were similar amongst treatment arms. No significant difference in resistance development was seen between the COL and COL + MEM groups overall (12% vs. 8%; p = 0.31), or in any subgroup (Table). In patients with A. baumannii, there was a trend towards decreased resistance development with COL + MEM (13.3% vs 7.5%; p = 0.13). Conclusion We were unable to identify a significant difference in resistance emergence between treatment arms, but given the low incidence of this outcome, were underpowered to do so. The impact of COL + MEM on preventing emergence of COL resistance in A. baumannii warrants further clinical study. Disclosures Jason M Pogue, PharmD, BCPS, BCIDP, Merck (Consultant)QPex (Consultant)Shionogi (Consultant)Utility Therapeutics (Consultant)VenatoRX (Consultant) Michael J. Rybak, PharmD, MPH, PhD, Paratek Pharmaceuticals (Research Grant or Support) Emmanuel Roilides, MD, PhD, FIDSA, FAAM, FESCMID, Merck Sharp & Dohme Corp. (Consultant, Grant/Research Support) Matthew Sims, MD, PhD, Astra Zeneca (Independent Contractor)Diasorin Molecular (Independent Contractor)Epigenomics Inc (Independent Contractor)Finch (Independent Contractor)Genentech (Independent Contractor)Janssen Pharmaceuticals NV (Independent Contractor)Kinevant Sciences gmBH (Independent Contractor)Leonard-Meron Biosciences (Independent Contractor)Merck and Co (Independent Contractor)OpGen (Independent Contractor)Prenosis (Independent Contractor)Regeneron Pharmaceuticals Inc (Independent Contractor)Seres Therapeutics Inc (Independent Contractor)Shire (Independent Contractor)Summit Therapeutics (Independent Contractor)

scholarly journals A synbiotic intervention modulates meta-omics signatures of gut redox potential and acidity in elective caesarean born infants

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Christophe Lay ◽  
Collins Wenhan Chu ◽  
Rikky Wenang Purbojati ◽  
Enzo Acerbi ◽  
Daniela I. Drautz-Moses ◽  
...  
Keyword(s):  
Risk Factor ◽  
Gut Microbiome ◽  
Reference Group ◽  
Mode Of Delivery ◽  
Controlled Study ◽  
Double Blind ◽  
Lipopolysaccharide Biosynthesis ◽  
Infant Gut Microbiome ◽  
Stool Samples ◽  
The Impact

Abstract Background The compromised gut microbiome that results from C-section birth has been hypothesized as a risk factor for the development of non-communicable diseases (NCD). In a double-blind randomized controlled study, 153 infants born by elective C-section received an infant formula supplemented with either synbiotic, prebiotics, or unsupplemented from birth until 4 months old. Vaginally born infants were included as a reference group. Stool samples were collected from day 3 till week 22. Multi-omics were deployed to investigate the impact of mode of delivery and nutrition on the development of the infant gut microbiome, and uncover putative biological mechanisms underlying the role of a compromised microbiome as a risk factor for NCD. Results As early as day 3, infants born vaginally presented a hypoxic and acidic gut environment characterized by an enrichment of strict anaerobes (Bifidobacteriaceae). Infants born by C-section presented the hallmark of a compromised microbiome driven by an enrichment of Enterobacteriaceae. This was associated with meta-omics signatures characteristic of a microbiome adapted to a more oxygen-rich gut environment, enriched with genes associated with reactive oxygen species metabolism and lipopolysaccharide biosynthesis, and depleted in genes involved in the metabolism of milk carbohydrates. The synbiotic formula modulated expression of microbial genes involved in (oligo)saccharide metabolism, which emulates the eco-physiological gut environment observed in vaginally born infants. The resulting hypoxic and acidic milieu prevented the establishment of a compromised microbiome. Conclusions This study deciphers the putative functional hallmarks of a compromised microbiome acquired during C-section birth, and the impact of nutrition that may counteract disturbed microbiome development. Trial registration The study was registered in the Dutch Trial Register (Number: 2838) on 4th April 2011.

scholarly journals Interactions of Oxysterols with Atherosclerosis Biomarkers in Subjects with Moderate Hypercholesterolemia and Effects of a Nutraceutical Combination (Bifidobacterium longum BB536, Red Yeast Rice Extract) (Randomized, Double-Blind, Placebo-Controlled Study)

Nutrients ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 427
Author(s):  
Stefania Cicolari ◽  
Chiara Pavanello ◽  
Elena Olmastroni ◽  
Marina Del Puppo ◽  
Marco Bertolotti ◽  
...  
Keyword(s):  
Bifidobacterium Longum ◽  
Density Lipoprotein ◽  
Lipoprotein Cholesterol ◽  
Mass Spectrometry Analysis ◽  
Abdominal Circumference ◽  
Controlled Study ◽  
Red Yeast Rice ◽  
Double Blind ◽  
Red Yeast ◽  
The Impact

Background: Oxysterol relationship with cardiovascular (CV) risk factors is poorly explored, especially in moderately hypercholesterolaemic subjects. Moreover, the impact of nutraceuticals controlling hypercholesterolaemia on plasma levels of 24-, 25- and 27-hydroxycholesterol (24-OHC, 25-OHC, 27-OHC) is unknown. Methods: Subjects (n = 33; 18–70 years) with moderate hypercholesterolaemia (low-density lipoprotein cholesterol (LDL-C:): 130–200 mg/dL), in primary CV prevention as well as low CV risk were studied cross-sectionally. Moreover, they were evaluated after treatment with a nutraceutical combination (Bifidobacterium longum BB536, red yeast rice extract (10 mg/dose monacolin K)), following a double-blind, randomized, placebo-controlled design. We evaluated 24-OHC, 25-OHC and 27-OHC levels by gas chromatography/mass spectrometry analysis. Results: 24-OHC and 25-OHC were significantly correlated, 24-OHC was correlated with apoB. 27-OHC and 27-OHC/total cholesterol (TC) were higher in men (median 209 ng/mL and 77 ng/mg, respectively) vs. women (median 168 ng/mL and 56 ng/mg, respectively); 27-OHC/TC was significantly correlated with abdominal circumference, visceral fat and, negatively, with high-density lipoprotein cholesterol (HDL-C). Triglycerides were significantly correlated with 24-OHC, 25-OHC and 27-OHC and with 24-OHC/TC and 25-OHC/TC. After intervention, 27-OHC levels were significantly reduced by 10.4% in the nutraceutical group Levels of 24-OHC, 24-OHC/TC, 25-OHC, 25-OHC/TC and 27-OHC/TC were unchanged. Conclusions: In this study, conducted in moderate hypercholesterolemic subjects, we observed novel relationships between 24-OHC, 25-OHC and 27-OHC and CV risk biomarkers. In addition, no adverse changes of OHC levels upon nutraceutical treatment were found.

scholarly journals Safe and persistent growth-promoting effects of vosoritide in children with achondroplasia: 2-year results from an open-label, phase 3 extension study

2021 ◽  
Author(s):  
Ravi Savarirayan ◽  
Louise Tofts ◽  
Melita Irving ◽  
William R. Wilcox ◽  
Carlos A. Bacino ◽  
...  
Keyword(s):  
Growth Velocity ◽  
Bone Growth ◽  
Growth Factor Receptor ◽  
Extension Study ◽  
Controlled Study ◽  
Open Label ◽  
Phase 3 ◽  
Double Blind ◽  
Pathogenic Variants ◽  
Growth Promoting

Abstract Purpose Achondroplasia is caused by pathogenic variants in the fibroblast growth factor receptor 3 gene that lead to impaired endochondral ossification. Vosoritide, an analog of C-type natriuretic peptide, stimulates endochondral bone growth and is in development for the treatment of achondroplasia. This phase 3 extension study was conducted to document the efficacy and safety of continuous, daily vosoritide treatment in children with achondroplasia, and the two-year results are reported. Methods After completing at least six months of a baseline observational growth study, and 52 weeks in a double-blind, placebo-controlled study, participants were eligible to continue treatment in an open-label extension study, where all participants received vosoritide at a dose of 15.0 μg/kg/day. Results In children randomized to vosoritide, annualized growth velocity increased from 4.26 cm/year at baseline to 5.39 cm/year at 52 weeks and 5.52 cm/year at week 104. In children who crossed over from placebo to vosoritide in the extension study, annualized growth velocity increased from 3.81 cm/year at week 52 to 5.43 cm/year at week 104. No new adverse effects of vosoritide were detected. Conclusion Vosoritide treatment has safe and persistent growth-promoting effects in children with achondroplasia treated daily for two years.

Exploring the Impact of Interaction Modality on Students’ Learning Performance

2021 ◽  
pp. 073563312110272
Author(s):  
Neila Chettaoui ◽  
Ayman Atia ◽  
Med Salim Bouhlel
Keyword(s):  
User Interfaces ◽  
Teaching Method ◽  
Learning Performance ◽  
Controlled Study ◽  
Embodied Interaction ◽  
Multimodal Learning ◽  
Tangible User Interfaces ◽  
Embodied Learning ◽  
Significant Difference ◽  
The Impact

Embodied learning pedagogy highlights the interconnections between the brain, body, and the concrete environment. As a teaching method, it provides means of engaging the physical body in multimodal learning experiences to develop the students’ cognitive process. Based on this perspective, several research studies introduced different interaction modalities to support the implementation of an embodied learning environment. One such case is the use of tangible user interfaces and motion-based technologies. This paper evaluates the impacts of motion-based, tangible-based, and multimodal interaction merging between tangible interfaces and motion-based technology on improving students’ learning performance. A controlled study was performed at a primary school with 36 participants (aged 7 to 9), to evaluate the educational potential of embodied interaction modalities compared to tablet-based learning. The results highlighted a significant difference in the learning gains between all groups, as determined by one-way ANOVA [F (3,32) = 6.32, p = .017], in favor of the multimodal learning interface. Findings revealed that a multimodal learning interface supporting richer embodied interaction that took advantage of affording the power of body movements and manipulation of physical objects might improve students’ understanding of abstract concepts in educational contexts.

Abstract TP146: Vagus Nerve Stimulation Paired With Rehabilitation To Improve Upper Limb Function

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Jesse Dawson ◽  
Theresa J Kimberley ◽  
Gerard E Francisco ◽  
Patricia Smith ◽  
Steven C Cramer ◽  
...  
Keyword(s):  
Vagus Nerve ◽  
Upper Extremity ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Human Study ◽  
Controlled Study ◽  
Eligibility Criteria ◽  
Double Blind ◽  
Upper Limb Function ◽  
Significant Difference

Introduction: Vagus Nerve Stimulation (VNS) paired with rehabilitation induces movement specific plasticity in rat motor cortex and improves forepaw function in a rat ischemic model compared to rehabilitation alone. A 20 subject first-in-human study in the UK indicated acceptable safety and feasibility of this approach in patients with arm weakness after stroke and showed a significant difference in favour of VNS paired with rehabilitation in the per-protocol analysis (Upper Extremity Fugl Meyer difference of 9.6 points for VNS vs. 3.0 Control; p = 0.038). We conducted a new, double-blind sham controlled study to further assess this technique. Methods: Subjects with chronic moderate to severe upper extremity hemiparesis secondary to ischemic stroke (Upper Extremity Fugl Meyer (UEFM) 20-50) were enrolled at four sites (3 US, 1 UK). After baseline assessments subjects were implanted with a vagus nerve stimulation device if all eligibility criteria were met. Following implantation, randomization was made to either paired VNS (1/2 second, 30 Hz., 0.8 mA, 100 uS stimulation with task-specific movement) or sham control (stimulation only on first 5 movements). All received the same intensive and task-specific rehabilitation and had 18 treatment sessions (2-hourly, 3 times a week for 6-weeks, approximately 50 repetitions per task and 300 to 400 repetition movements per session). Outcomes were assessed on the first and 30 th day following completion of the 6-week therapy course. Results: Sixteen patients (8 female) were implanted (8 VNS, 8 Control). Mean age (SD) was 63.2(6.9), with an average (SD) of 21.7 months (12.9) post stroke. One study related serious adverse event was reported (a wound infection that resolved with IV antibiotics). Blinded results (change in UEFM, WMFT, and UEFM responders for both groups) will be available and presented. Conclusions: A pivotal study of VNS paired with rehabilitation movements will be justified if preliminary results are confirmed.

scholarly journals Involvement of N-methyl-d-aspartate receptors in plasticity induced by paired corticospinal-motoneuronal stimulation in humans

2018 ◽  
Vol 119 (2) ◽  
pp. 652-661 ◽  
Author(s):  
Siobhan C. Dongés ◽  
Jessica M. D’Amico ◽  
Jane E. Butler ◽  
Janet L. Taylor
Keyword(s):  
Biceps Brachii ◽  
Motor Evoked Potentials ◽  
Controlled Study ◽  
Spinal Level ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Human Spinal Cord ◽  
Significant Difference ◽  
Antidromic Potentials ◽  
Dependent Mechanism

Plasticity can be induced at human corticospinal-motoneuronal synapses by delivery of repeated, paired stimuli to corticospinal axons and motoneurons in a technique called paired corticospinal-motoneuronal stimulation (PCMS). To date, the mechanisms of the induced plasticity are unknown. To determine whether PCMS-induced plasticity is dependent on N-methyl-d-aspartate receptors (NMDARs), the effect of the noncompetitive NMDAR antagonist dextromethorphan on PCMS-induced facilitation was assessed in a 2-day, double-blind, placebo-controlled experiment. PCMS consisted of 100 pairs of stimuli, delivered at an interstimulus interval that produces facilitation at corticospinal-motoneuronal synapses that excite biceps brachii motoneurons. Transcranial magnetic stimulation elicited corticospinal volleys, which were timed to arrive at corticospinal-motoneuronal synapses just before antidromic potentials elicited in motoneurons with electrical brachial plexus stimulation. To measure changes in the corticospinal pathway at a spinal level, biceps responses to cervicomedullary stimulation (cervicomedullary motor evoked potentials, CMEPs) were measured before and for 30 min after PCMS. Individuals who displayed a ≥10% increase in CMEP size after PCMS on screening were eligible to take part in the 2-day experiment. After PCMS, there was a significant difference in CMEP area between placebo and dextromethorphan days ( P = 0.014). On the placebo day PCMS increased average CMEP areas to 127 ± 46% of baseline, whereas on the dextromethorphan day CMEP area was decreased to 86 ± 33% of baseline (mean ± SD; placebo: n = 11, dextromethorphan: n = 10). Therefore, dextromethorphan suppressed the facilitation of CMEPs after PCMS. This indicates that plasticity induced at synapses in the human spinal cord by PCMS may be dependent on NMDARs. NEW & NOTEWORTHY Paired corticospinal-motoneuronal stimulation can strengthen the synaptic connections between corticospinal axons and motoneurons at a spinal level in humans. The mechanism of the induced plasticity is unknown. In our 2-day, double-blind, placebo-controlled study we show that the N-methyl-d-aspartate receptor (NMDAR) antagonist dextromethorphan suppressed plasticity induced by paired corticospinal-motoneuronal stimulation, suggesting that an NMDAR-dependent mechanism is involved.

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