Utility of a personalised Bronchiectasis Action Management Plan (BAMP) for children with bronchiectasis: protocol for a multicentre, double-blind parallel, superiority randomised controlled trial

IntroductionBronchiectasis is no longer considered rare or irreversible in children, yet it remains relatively under-researched and neglected in respiratory health globally. Bronchiectasis (including chronic suppurative lung disease) causes substantial morbidity for patients and significant impact on caregivers, especially during acute respiratory exacerbations. In other chronic respiratory diseases (eg, asthma), empowering consumers with an individualised plan for management of acute exacerbations improves clinical outcomes. However, in the absence of any such data specific to bronchiectasis, action management plans are rarely currently used in children or adults with bronchiectasis. We hypothesise that providing an individualised bronchiectasis action management plan (BAMP) to children with bronchiectasis reduces non-scheduled doctor consultations, compared with not having a BAMP.Methods and analysisThis multicentre, parallel, double-blind, randomised trial involving three urban Australian hospitals commenced in June 2018 and will include 198 children, aged <19 years with bronchiectasis who had 2 or more exacerbations in the previous 18 months. Children will be randomised to having an individualised BAMP or standard care (a decoy clinic letter). Primary caregivers will then be followed up monthly for 12 months. The primary outcome is the rate of acute non-scheduled doctor visits for respiratory exacerbations by 12 months. The main secondary outcomes are cough-specific quality of life scores at 6 and 12 months, overall exacerbation rate over 12 months, and proportion of children who received timely influenza vaccination by 30 May annually.Ethics and disseminationThe Human Research Ethics Committees of the Northern Territory Department of Health and Menzies School of Heath Research and Queensland Children’s Hospital approved the study. The results of the trial will be submitted for publication and the BAMP made available free online.Trial registration numberAustralia and New Zealand Clinical Trials Register ACTRN12618000604202.

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A multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation (the SHINE trial): a study protocol

BMJ Open ◽

10.1136/bmjopen-2020-039230 ◽

2020 ◽

Vol 10 (10) ◽

pp. e039230

Author(s):

Kate A Hodgson ◽

Louise S Owen ◽

Camille Omar Kamlin ◽

Calum T Roberts ◽

Susan M Donath ◽

...

Keyword(s):

Endotracheal Intubation ◽

Controlled Trial ◽

Randomised Trial ◽

Upper Airway ◽

Ethics Committees ◽

High Flow ◽

Successful Intubation ◽

Peripheral Oxygen Saturation ◽

Human Research Ethics ◽

Randomised Controlled

IntroductionNeonatal endotracheal intubation is an essential but potentially destabilising procedure. With an increased focus on avoiding mechanical ventilation, particularly in preterm infants, there are fewer opportunities for clinicians to gain proficiency in this important emergency skill. Rates of successful intubation at the first attempt are relatively low, and adverse event rates are high, when compared with intubations in paediatric and adult populations. Interventions to improve operator success and patient stability during neonatal endotracheal intubations are needed. Using nasal high flow therapy extends the safe apnoea time of adults undergoing upper airway surgery and during endotracheal intubation. This technique is untested in neonates.Methods and analysisThe Stabilisation with nasal High flow during Intubation of NEonates (SHINE) trial is a multicentre, randomised controlled trial comparing the use of nasal high flow during neonatal intubation with standard care (no nasal high flow). Intubations are randomised individually, and stratified by site, use of premedications, and postmenstrual age (<28 weeks’ gestation; ≥28 weeks’ gestation). The primary outcome is the incidence of successful intubation on the first attempt without physiological instability of the infant. Physiological instability is defined as an absolute decrease in peripheral oxygen saturation >20% from preintubation baseline and/or bradycardia (<100 beats per minute).Ethics and disseminationThe SHINE trial received ethical approval from the Human Research Ethics Committees of The Royal Women’s Hospital, Melbourne, Australia and Monash Health, Melbourne, Australia. The trial is currently recruiting in these two sites. The findings of this study will be disseminated via peer-reviewed journals and presented at national and international conferences.Trial registration numberACTRN12618001498280.

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Pelargonium sidoides root extract for the treatment of acute cough due to lower respiratory tract infection in adults: a feasibility double-blind, placebo-controlled randomised trial

BMC Complementary Medicine and Therapies ◽

10.1186/s12906-021-03206-4 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Merlin Willcox ◽

Catherine Simpson ◽

Sam Wilding ◽

Beth Stuart ◽

Dia Soilemezi ◽

...

Keyword(s):

Primary Care ◽

Controlled Trial ◽

Randomised Trial ◽

Acute Bronchitis ◽

Antibiotic Prescribing ◽

Root Extract ◽

Double Blind ◽

Double Blind Placebo ◽

Link Type ◽

Pelargonium Sidoides

Abstract Background Pelargonium sidoides DC (Geraniaceae) root extract, EPs®7630 or “Kaloba®”, is a widely used herbal remedy for respiratory infections, with some evidence of effectiveness for acute bronchitis. However, it is not yet widely recommended by medical professionals in the UK. There is a need to undertake appropriately designed randomised trials to test its use as an alternative to antibiotics. The aim was to assess the feasibility of conducting a double-blind randomised controlled trial of Pelargonium sidoides root extract for treatment of acute bronchitis in UK primary care, investigating intervention compliance, patient preference for dosage form and acceptability of patient diaries. Study design Feasibility double-blind randomised placebo-controlled clinical trial. Methods We aimed to recruit 160 patients with cough (≤ 21 days) caused by acute bronchitis from UK general practices. Practices were cluster-randomised to liquid or tablet preparations and patients were individually randomised to Kaloba® or placebo. We followed participants up for 28 days through self-reported patient diaries with telephone support and reviewed medical records at one month. Outcomes included recruitment, withdrawal, safety, reconsultation and symptom diary completion rates. We also assessed treatment adherence, antibiotic prescribing and consumption, mean symptom severity (at days 2–4 after randomisation) and time to symptom resolution. We interviewed 29 patients and 11 health professionals to identify barriers and facilitators to running such a randomised trial. Results Of 543 patients screened, 261 were eligible, of whom 134 (51%) were recruited and 103 (77%) returned a completed diary. Overall, 41% (41/100) of patients took antibiotics (Kaloba® liquid group: 48% [15/31]; placebo liquid group: 23% [6/26]; Kaloba® tablet group: 48% [9/21]; placebo tablet group: 50% [11/22]). Most patients adhered to the study medication (median 19 out of 21 doses taken in week 1, IQR 18–21 - all arms combined). There were no serious adverse events relating to treatment. Most patients interviewed found study recruitment to be straightforward, but some found the diary too complex. Conclusions It was feasible and acceptable to recruit patients from UK primary care to a double-blind placebo-controlled trial of herbal medicine (Kaloba®) for the treatment of acute bronchitis, with good retention and low data attrition. Trial registration HATRIC was registered on the ISRCTN registry (ISRCTN17672884) on 16 August 2018, retrospectively registered. The record can be found at http://www.isrctn.com/ISRCTN17672884.

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The effects of maternal and infant vitamin A supplementation on vitamin A status: a randomised trial in Kenya

British Journal Of Nutrition ◽

10.1017/s0007114507705019 ◽

2007 ◽

Vol 98 (2) ◽

pp. 422-430 ◽

Cited By ~ 25

Author(s):

R. A. Ayah ◽

D. L. Mwaniki ◽

P. Magnussen ◽

A. E. Tedstone ◽

T. Marshall ◽

...

Keyword(s):

Vitamin A ◽

Controlled Trial ◽

Randomised Trial ◽

Maternal Serum ◽

High Dose ◽

Serum Retinol ◽

Double Blind ◽

Vitamin A Supplementation ◽

Factors Affecting ◽

Vitamin A Status

Postpartum vitamin A supplementation of mothers and infants is recommended, but the efficacy has been questioned. In this double-blind, placebo-controlled trial, Kenyan mother–infant pairs were randomised to maternal vitamin A (400 000 IU) or placebo < 24 h postpartum, and infant vitamin A (100 000 IU) or placebo at 14 weeks. Milk retinol was determined at weeks 4, 14 and 26, and maternal and infant serum retinol at weeks 14 and 26. Infant retinol stores were assessed at week 26, using a modified relative dose response (MRDR) test. Among 564 women, serum retinol at 36 weeks gestation was 0·81 (sd 0·21) μmol/l, and 33·3 % were < 0·7 μmol/l. Maternal serum retinol was not different between groups, but milk retinol was higher in the vitamin A group: (0·67 v. 0·60 μmol/l; 0·52 v. 0·44 μmol/l; 0·50 v. 0·44 μmol/l at 4, 14 and 26 weeks, respectively). When expressed per gram fat, milk retinol was higher in the vitamin A group only at 4 weeks. Infant serum retinol was not different between groups. However, although most infants had deficient vitamin A stores (MRDR>0·06 %) at 26 weeks, vitamin A to infants, but not mothers, resulted in a lower proportion of infants with deficient vitamin A stores (69 v. 78 %). High-dose postpartum vitamin A supplementation failed to increase serum retinol and infant stores, despite modest effects on milk retinol. Infant supplementation, however, increased stores. There is a need for a better understanding of factors affecting absorption and metabolism of vitamin A.

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Efficacy and safety of HX 110-A and HX 110-B in promoting respiratory health: An 8-week, randomized, double-blind, parallel group, placebo-controlled trial

10.21203/rs.2.22178/v1 ◽

2020 ◽

Author(s):

Jung-Kyu Lee ◽

Bumjo Oh ◽

Seo-Young Yoon ◽

Tae Yun Park ◽

Eun Young Heo ◽

...

Keyword(s):

Lung Function ◽

Respiratory Disease ◽

Respiratory Symptoms ◽

Respiratory Health ◽

Controlled Trial ◽

Clinical Pathology ◽

Double Blind ◽

Parallel Group ◽

Anti Inflammatory ◽

Experimental Group

Abstract Background HX110-A and HX110-B are compound extracts based on radix adenophorae and rhizoma dioscoreae, respectively, which have anti-inflammatory activity. There are limited data on whether they may help improve respiratory conditions including lung function. Therefore, in this trial, we will evaluate the effectiveness and safety of the use of HX110-A and HX110-B for the treatment of respiratory health in adults with mild respiratory symptoms. Methods/design This will be an 8-week, randomized, double-blind, parallel group, placebo-controlled trial with three arms. Adults more than 40 years old with persistent respiratory symptoms will be enrolled. Patients with definite respiratory disease or with a history of recent intake of antioxidants or anti-inflammatory agents will be excluded. Study subjects will be assigned at a 1:1:1 ratio into the following three arms: controls, experimental group 1 (HX110-A), and experimental group 2 (HX110-B). Control or experimental foods will be administered for 8 weeks, and follow-up will be up to 12 weeks. The primary outcome will be total antioxidant capacity. Secondary outcomes will be inflammatory indexes, respiratory symptoms, lung function, quality of life, and fatigue level. Safety outcomes will be assessed by monitoring adverse events and vital signs, and through clinical pathology tests. Conclusion We hope that this trial will reveal the effectiveness and safety of HX110-A and/or HX110-B for medical purposes in adults with respiratory symptoms. The results should clarify if active intake of specific foods with these functional compounds may promote respiratory health in adults without definite respiratory disease.

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CoMET: a protocol for a randomised controlled trial of co-commencement of METformin as an adjunctive treatment to attenuate weight gain and metabolic syndrome in patients with schizophrenia newly commenced on clozapine

BMJ Open ◽

10.1136/bmjopen-2017-021000 ◽

2018 ◽

Vol 8 (3) ◽

pp. e021000 ◽

Cited By ~ 5

Author(s):

Dan Siskind ◽

Nadia Friend ◽

Anthony Russell ◽

John J McGrath ◽

Carmen Lim ◽

...

Keyword(s):

Metabolic Syndrome ◽

Body Weight ◽

Weight Gain ◽

Controlled Trial ◽

Adjunctive Treatment ◽

Double Blind ◽

Human Research Ethics ◽

Increased Risk ◽

Point Body ◽

Randomised Controlled

IntroductionClozapine, while effective in treatment refractory schizophrenia, is associated with significant weight gain, heart disease and increased risk of type 2 diabetes mellitus (T2DM). Although there is evidence for weight loss with metformin for people with obesity who are already taking clozapine, there have been no published trials that have investigated the effect of metformin in attenuating weight gain at the time of clozapine initiation.Methods and analysisA 24-week double-blind placebo-controlled trial of concomitant prescription of metformin at clozapine commencement. Eighty-six people being commenced on clozapine will be randomised to placebo or metformin (variable dose, up to 2 g/day). The primary outcome is comparative end point body weight, between the placebo and metformin groups. Secondary outcomes are comparative rates of conversion to T2DM, alteration of metabolic syndrome parameters, proportion gaining >5% body weight and changes in diet and appetite. We will additionally examine biomarkers associated with change in weight among trial participants.Ethics and disseminationEthics approval was granted by the Metro South Human Research Ethics Committee HREC/17/QPAH/538-SSA/17/QPAH/565. We plan to submit a manuscript of the results to a peer-reviewed journal, and present results at conferences, consumer forums and hospital grand rounds.Trial registration numberACTRN12617001547336; Pre-results.

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Chewing gum to treat postoperative nausea and emesis in female patients (CHEWY): rationale and design for a multicentre randomised trial

BMJ Open ◽

10.1136/bmjopen-2018-027505 ◽

2019 ◽

Vol 9 (6) ◽

pp. e027505

Author(s):

Jai Darvall ◽

Britta Sylvia von Ungern-Sternberg ◽

Sabine Braat ◽

David Story ◽

Andrew Davidson ◽

...

Keyword(s):

General Anaesthesia ◽

Postoperative Nausea ◽

Controlled Trial ◽

Randomised Trial ◽

Ethics Committees ◽

Complete Response ◽

Chewing Gum ◽

Female Patients ◽

Patient Dissatisfaction ◽

Randomised Controlled

IntroductionPostoperative nausea, retching and vomiting (PONV) remains one of the most common side effects of general anaesthesia, contributing significantly to patient dissatisfaction, cost and complications. Chewing gum has potential as a novel, drug-free alternative treatment. We aim to conduct a large, definitive randomised controlled trial of the efficacy and safety of peppermint-flavoured chewing gum to treat PONV in the postanaesthesia care unit (PACU). If chewing gum is shown to be as effective as ondansetron, this trial has the potential to significantly improve outcomes for tens of millions of surgical patients around the world each year.Methods and analysisThis is a prospective, multicentre, randomised controlled non-inferiority trial. 272 female patients aged ≥12 years having volatile anaesthetic-based general anaesthesia for breast or laparoscopic surgery will be randomised. Patients experiencing nausea, retching or vomiting in PACU will be randomised to 15 min of chewing gum or 4 mg intravenous ondansetron. The primary outcome (complete response) is cessation of PONV within 2 hours of administration, with no recurrence nor rescue medication requirement for 2 hours after administration.Ethics and disseminationThe Chewy Trial has been approved by the Human Research Ethics Committees at all sites. Dissemination will be via international and national anaesthesia conferences, and publication in the peer-reviewed literature.Trial registration numberACTRN12618000429257; Pre-results.

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Vitamin C to pregnant smokers persistently improves infant airway function to 12 months of age: a randomised trial

European Respiratory Journal ◽

10.1183/13993003.02208-2019 ◽

2020 ◽

Vol 56 (6) ◽

pp. 1902208 ◽

Cited By ~ 1

Author(s):

Cindy T. McEvoy ◽

Lyndsey E. Shorey-Kendrick ◽

Kristin Milner ◽

Diane Schilling ◽

Christina Tiller ◽

...

Keyword(s):

Vitamin C ◽

Repeated Measures ◽

Controlled Trial ◽

Randomised Trial ◽

Analysis Of Covariance ◽

Secondary Outcome ◽

Double Blind ◽

Smoking Cessation Counselling ◽

Airway Function ◽

Pregnant Smokers

BackgroundVitamin C (500 mg·day−1) supplementation for pregnant smokers has been reported to increase newborn pulmonary function and infant forced expiratory flows (FEFs) at 3 months of age. Its effect on airway function through 12 months of age has not been reported.ObjectiveTo assess whether vitamin C supplementation to pregnant smokers is associated with a sustained increased airway function in their infants through 12 months of age.MethodsThis is a pre-specified secondary outcome of a randomised, double-blind, placebo-controlled trial that randomised 251 pregnant smokers between 13 and 23 weeks of gestation: 125 to 500 mg·day−1 vitamin C and 126 to placebo. Smoking cessation counselling was provided. FEFs performed at 3 and 12 months of age were analysed by repeated-measures analysis of covariance.ResultsFEFs were performed in 222 infants at 3 months and 202 infants at 12 months of age. The infants allocated to vitamin C had significantly increased FEFs over the first year of life compared to those allocated to placebo. The overall increased flows were 40.2 mL·s−1 for at FEF75 (75% of forced vital capacity (FVC)) (adjusted 95% CI for difference 6.6–73.8; p=0.025); 58.3 mL·s−1 for FEF50 (10.9–105.8; p=0.0081); and 55.1 mL·s−1 for FEF25–75 (9.7–100.5; p=0.013).ConclusionsIn offspring of pregnant smokers randomised to vitamin C versus placebo, vitamin C during pregnancy was associated with a small but significantly increased airway function at 3 and 12 months of age, suggesting a potential shift to a higher airway function trajectory curve. Continued follow-up is underway.

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The Effects of Clinical Hypnosis versus Neurolinguistic Programming (NLP) before External Cephalic Version (ECV): A Prospective Off-Centre Randomised, Double-Blind, Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2012/626740 ◽

2012 ◽

Vol 2012 ◽

pp. 1-6 ◽

Cited By ~ 3

Author(s):

Joscha Reinhard ◽

Swati Peiffer ◽

Nicole Sänger ◽

Eva Herrmann ◽

Juping Yuan ◽

...

Keyword(s):

Medical Care ◽

Success Rate ◽

Controlled Trial ◽

Randomised Trial ◽

External Cephalic Version ◽

Control Group ◽

Amniotic Fluid Index ◽

Double Blind ◽

Standard Medical Care ◽

Clinical Hypnosis

Objective. To examine the effects of clinical hypnosis versus NLP intervention on the success rate of ECV procedures in comparison to a control group.Methods. A prospective off-centre randomised trial of a clinical hypnosis intervention against NLP of women with a singleton breech fetus at or after 370/7(259 days) weeks of gestation and normal amniotic fluid index. All 80 participants heard a 20-minute recorded intervention via head phones. Main outcome assessed was success rate of ECV. The intervention groups were compared with a control group with standard medical care alone ().Results. A total of 42 women, who received a hypnosis intervention prior to ECV, had a 40.5% (), successful ECV, whereas 38 women, who received NLP, had a 44.7% () successful ECV (). The control group had similar patient characteristics compared to the intervention groups (). In the control group () 27.3% () had a statistically significant lower successful ECV procedure than NLP () and hypnosis and NLP ().Conclusions. These findings suggest that prior clinical hypnosis and NLP have similar success rates of ECV procedures and are both superior to standard medical care alone.

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RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis

European Respiratory Journal ◽

10.1183/13993003.02052-2017 ◽

2018 ◽

Vol 51 (1) ◽

pp. 1702052 ◽

Cited By ~ 81

Author(s):

Anthony De Soyza ◽

Timothy Aksamit ◽

Tiemo-Joerg Bandel ◽

Margarita Criollo ◽

J. Stuart Elborn ◽

...

Keyword(s):

Cystic Fibrosis ◽

Incidence Rate Ratio ◽

Controlled Trial ◽

Randomised Trial ◽

Phase Iii ◽

Efficacy And Safety ◽

Dry Powder ◽

Effective Treatment Option ◽

Double Blind ◽

Treatment Regimens

We evaluated the efficacy and safety of ciprofloxacin dry powder for inhalation (DPI) in patients with non-cystic fibrosis bronchiectasis, two or more exacerbations in the previous year and pre-defined bacteria in sputum.In this phase III, double-blind, placebo-controlled trial, patients were randomised 2:1 to twice-daily ciprofloxacin DPI 32.5 mg or placebo in two treatment regimens consisting of on/off treatment cycles of 14 or 28 days for 48 weeks. The primary end-points were time to first exacerbation and frequency of exacerbations.A total of 416 patients were randomised to the 14-day on/off regimen (ciprofloxacin DPI (n=137) and placebo (n=68)) or the 28-day on/off regimen (ciprofloxacin DPI (n=141) and placebo (n=70)). Ciprofloxacin DPI 14 days on/off significantly prolonged time to first exacerbationversuspooled placebo (median time >336versus186 days; hazard ratio 0.53, 97.5% CI 0.36–0.80; p=0.0005) and reduced the frequency of exacerbations compared with matching placebo by 39% (mean number of exacerbations 0.6versus1.0; incidence rate ratio 0.61, 97.5% CI 0.40–0.91; p=0.0061). Outcomes for ciprofloxacin DPI 28 days on/off were not statistically significantly different from placebo. The safety profile of ciprofloxacin DPI was favourable.Ciprofloxacin DPI was well tolerated and has the potential to be an effective treatment option in non-cystic fibrosis bronchiectasis.

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Iron status and inherited haemoglobin disorders modify the effects of micronutrient powders on linear growth and morbidity among young Lao children in a double-blind randomised trial

British Journal Of Nutrition ◽

10.1017/s0007114519001715 ◽

2019 ◽

Vol 122 (8) ◽

pp. 895-909 ◽

Cited By ~ 2

Author(s):

Sonja Y. Hess ◽

K. Ryan Wessells ◽

Guy-Marino Hinnouho ◽

Maxwell A. Barffour ◽

Kanokwan Sanchaisuriya ◽

...

Keyword(s):

Iron Status ◽

Controlled Trial ◽

Randomised Trial ◽

Double Blind ◽

Adverse Health Outcomes ◽

Modifying Factors ◽

Micronutrient Powder ◽

Haemoglobin Disorders ◽

Clinically Significant ◽

The Impact

AbstractSome studies found that providing micronutrient powder (MNP) causes adverse health outcomes, but modifying factors are unknown. We aimed to investigate whether Fe status and inherited Hb disorders (IHbD) modify the impact of MNP on growth and diarrhoea among young Lao children. In a double-blind controlled trial, 1704 children of age 6–23 months were randomised to daily MNP (with 6 mg Fe plus fourteen micronutrients) or placebo for about 36 weeks. IHbD, and baseline and final Hb, Fe status and anthropometrics were assessed. Caregivers provided weekly morbidity reports. At enrolment, 55·6 % were anaemic; only 39·3 % had no sign of clinically significant IHbD. MNP had no overall impact on growth and longitudinal diarrhoea prevalence. Baseline Hb modified the effect of MNP on length-for-age (LAZ) (P for interaction = 0·082). Among children who were initially non-anaemic, the final mean LAZ in the MNP group was slightly lower (–1·93 (95 % CI –1·88, –1·97)) v. placebo (–1·88 (95 % CI –1·83, –1·92)), and the opposite occurred among initially anaemic children (final mean LAZ –1·90 (95 % CI –1·86, –1·94) in MNP v. –1·92 (95 % CI –1·88, –1·96) in placebo). IHbD modified the effect on diarrhoea prevalence (P = 0·095). Among children with IHbD, the MNP group had higher diarrhoea prevalence (1·37 (95 % CI 1·17, 1·59) v. 1·21 (95 % CI 1·04, 1·41)), while it was lower among children without IHbD who received MNP (1·15 (95 % CI 0·95, 1·39) v. 1·37 (95 % CI 1·13, 1·64)). In conclusion, there was a small adverse effect of MNP on growth among non-anaemic children and on diarrhoea prevalence among children with IHbD.

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