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BReastfeeding Attitude and Volume Optimization (BRAVO) trial: study protocol for a randomized controlled trial.

ABSTRACT: A growing body of evidence shows the short-term benefits of breastfeeding, which include protection against infections, allergies, and lung diseases. However, evidence on the long-term benefits of breastfeeding is scarce and often conflicting. The BReastfeeding Attitude and Volume Optimization (BRAVO) trial is designed to study the effect of breastfeeding on early signs of later chronic diseases, particularly cardiovascular, respiratory, and metabolic risks later in life. In addition, the effectiveness of breastfeeding empowerment in promoting breastfeeding will also be evaluated.This study is an ongoing randomized trial in Jakarta, Indonesia, that began in July 2012. Pregnant women are being screened for their breastfeeding plan in the third trimester, and those with low intention to breastfeed are randomly allocated to either receiving an add-on breastfeeding-optimization program or usual care. Primary outcomes include breastfeeding rate, lung function, and blood pressure during the first year of life and vascular/cardiac characteristics, which will be measured at the age of 4 to 5 years. Child growth and infection/illness episodes are measured, whereas cognitive testing is planned for the children at 5 years of age.To date, 784 women (80 %) have been randomized of the 1,000 planned, with satisfactory completeness of the 1-year follow up (90.1 %). Included mothers are of lower socioeconomic status and more often have blue-collar jobs, similar to what was observed in the pilot study.ClinicalTrials.gov, NCT01566812 . Registered on 27 March 2012.

SUBMITTER: Savitri AI

PROVIDER: S-EPMC4890480 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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BReastfeeding Attitude and Volume Optimization (BRAVO) trial: study protocol for a randomized controlled trial.

Savitri Ary I AI Idris Nikmah S NS Indawati Wahyuni W Saldi Siti Rizny F SR Amelia Dwirani D Baharuddin Mohammad M Sastroasmoro Sudigdo S Grobbee Diederick E DE Uiterwaal Cuno S P M CS

Trials 20160602 1

<h4>Background</h4>A growing body of evidence shows the short-term benefits of breastfeeding, which include protection against infections, allergies, and lung diseases. However, evidence on the long-term benefits of breastfeeding is scarce and often conflicting. The BReastfeeding Attitude and Volume Optimization (BRAVO) trial is designed to study the effect of breastfeeding on early signs of later chronic diseases, particularly cardiovascular, respiratory, and metabolic risks later in life. In a ...[more]

PMID: 27250730

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Project description:ObjectivesBRAVO (British Randomized Controlled Trial of AV and VV Optimization) is a multicenter, randomized, crossover, noninferiority trial comparing echocardiographic optimization of atrioventricular (AV) and interventricular delay with a noninvasive blood pressure method.BackgroundCardiac resynchronization therapy including AV delay optimization confers clinical benefit, but the optimization requires time and expertise to perform.MethodsThis study randomized patients to echocardiographic optimization or hemodynamic optimization using multiple-replicate beat-by-beat noninvasive blood pressure at baseline; after 6 months, participants were crossed over to the other optimization arm of the trial. The primary outcome was exercise capacity, quantified as peak exercise oxygen uptake. Secondary outcome measures were echocardiographic left ventricular (LV) remodeling, quality-of-life scores, and N-terminal pro-B-type natriuretic peptide.ResultsA total of 401 patients were enrolled, the median age was 69 years, 78% of patients were men, and the New York Heart Association functional class was II in 84% and III in 16%. The primary endpoint, peak oxygen uptake, met the criterion for noninferiority (pnoninferiority = 0.0001), with no significant difference between the hemodynamically optimized arm and echocardiographically optimized arm of the trial (mean difference 0.1 ml/kg/min). Secondary endpoints for noninferiority were also met for symptoms (mean difference in Minnesota score 1; pnoninferiority = 0.002) and hormonal changes (mean change in N-terminal pro-B-type natriuretic peptide -10 pg/ml; pnoninferiority = 0.002). There was no significant difference in LV size (mean change in LV systolic dimension 1 mm; pnoninferiority < 0.001; LV diastolic dimension 0 mm; pnoninferiority <0.001). In 30% of patients the AV delay identified as optimal was more than 20 ms from the nominal setting of 120 ms.ConclusionsOptimization of cardiac resynchronization therapy devices by using noninvasive blood pressure is noninferior to echocardiographic optimization. Therefore, noninvasive hemodynamic optimization is an acceptable alternative that has the potential to be automated and thus more easily implemented. (British Randomized Controlled Trial of AV and VV Optimization [BRAVO]; NCT01258829).

Project description:Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening. Adenoma detection rate is a marker of high quality colonoscopy and a high adenoma detection rate is associated with a lower incidence of interval cancers. Several technological advancements have been explored to improve adenoma detection rate. A new device called Endocuff Vision™ has been shown to improve adenoma detection rate in pilot studies.This is a prospective, multicenter, randomized controlled trial comparing the adenoma detection rate in patients undergoing Endocuff Vision™-assisted colonoscopy with standard colonoscopy. All patients above 18 years of age referred for screening, surveillance, or diagnostic colonoscopy who are able to consent are invited to the study. Patients with absolute contraindications to colonoscopy, large bowel obstruction or pseudo-obstruction, colon cancer or polyposis syndromes, colonic strictures, severe diverticular segments, active colitis, anticoagulant therapy, or pregnancy are excluded. Patients are randomized according to site, age, sex, and bowel cancer screening status to receive Endocuff Vision™-assisted colonoscopy or standard colonoscopy on the day of procedure. Baseline data, colonoscopy, and polyp data including histology are collected. Nurse assessment of patient comfort and patient comfort questionnaires are completed post procedure. Patients are followed up at 21 days and complete a patient experience questionnaire. This study will take place across seven NHS Hospital Trusts: one in London and six within the Northern Region Endoscopy Group. A maximum of 10 colonoscopists per site will recruit a total of 1772 patients, with a maximum of four bowel screening colonoscopists permitted per site.This is the first trial to evaluate the adenoma detection rate of Endocuff Vision™ in all screening, surveillance, and diagnostic patient groups. This timely study will guide clinicians as to the role of Endocuff Vision™ in routine colonoscopy.ISRCTN11821044.

Project description:BACKGROUND: The number of people with diabetes is increasing worldwide, especially in developing South Asian countries. Therefore, preventing diabetes at the early stages has become an important issue. Recent clinical trials, systematic reviews, and meta-analysis have shown that zinc has beneficial effects on glycemic and metabolic control in those with diabetes. The present study is designed to evaluate the effects of zinc supplementation on glycemic control and other metabolic parameters in those with pre-diabetes. METHODS/DESIGN: The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 12 months at the Faculty of Medicine, University of Colombo, Sri Lanka. The study has been approved by the Ethics Review Committee of Faculty of Medicine, University of Colombo (EC/11/189). A total of 200 adults (age 18-60 years) with pre-diabetes will be recruited for the study. They will be stratified according to age, gender, and body mass index and randomly assigned into the test and placebo groups on a 1:1 ratio. The zinc capsules, each weighing 456 mg, will contain the following ingredients:zinc sulfate monohydrate 55.096 mg (elemental zinc 20 mg), lactose monohydrate 399.504 mg, and stearic acid 1.400 mg. The placebo capsule with the same weight will be comprised of lactose monohydrate 454.600 mg and stearic acid 1.400 mg. The subjects will receive either zinc 20 mg capsules or placebo daily for a period of 12 months. The study drugs will be double blinded to both investigators and subjects. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 3 month (visit 2), 6 month (visit 3), and 12 month (visit 4). The following primary outcome measures will be evaluated:fasting plasma glucose (FPG), post oral glucose tolerance test (OGTT), serum insulin, HbA1c, total/low-density lipoprotein (LDL)/high-density lipoprotein (HDL) cholesterol, triglycerides, serum zinc, and appetite using a visual analog scale. Secondary outcome measures include: blood pressure, anthropometry, and dietary assessment using a validated food frequency questionnaire. Data will be analyzed using SPSS v16. DISCUSSION: The present protocol will aim to establish the beneficial effects of zinc supplementation on disease progression in those with pre-diabetes and also establish its effectiveness in the prevention of diabetes mellitus. TRIAL REGISTRATION: Sri Lanka Clinical Trial Registry: SLCTR/2012/010.

Project description:IntroductionComplete recovery after surgery depends on psychological factors such as preoperative information, expectations, and surgery-associated anxiety. Prior studies have shown that even a short preoperative psychological intervention aiming at optimized expectations (EXPECT) can improve postoperative outcomes in coronary artery bypass patients. However, this intervention may benefit only a small subgroup of heart surgery patients since implementing preoperative psychological interventions into the daily clinical routine is difficult due to the additional time and appointments. It is unclear whether the EXPECT intervention can be shortened and whether heart valve patients would also benefit from interventions that optimize patients' expectations. The multicenter ValvEx trial aims (i) to adapt an effective preoperative psychological intervention (EXPECT) to make it brief enough to be easily integrated into the preoperative routine of heart valve patients and (ii) to examine if the adapted preoperative psychological intervention improves the subjectively perceived illness-related disability (PDI) up to 3 months after surgery.Materials and analysisIn two German university hospitals, N = 88 heart valve patients who undergo heart surgery are randomized into two groups [standard of care (SOC) vs. standard of care plus interventional expectation manipulation (SOC and EXPECT)] after baseline assessment. Patients in the EXPECT group additionally to standard of care participate in the preoperative psychological intervention (30-40 min), focusing on optimizing expectations and have two booster-telephone calls (4 and 8 weeks after the surgery, approx. 15 min). Both groups have assessments again on the evening before the surgery, 4 to 6 days, and 3 months after the surgery.DiscussionThe trial demonstrates excellent feasibility in the clinical routine and a high interest by the patients.Ethics and disseminationThe Ethics Committees of the Department of Medicine of the Philipps University of Marburg and the Department of Medicine of the University of Giessen approved the study protocol. Study results will be published in peer-reviewed journals and presented at congresses.Clinical trial registrationClinicalTrials.gov, identifier NCT04502121.

Project description:The use of nicotine replacement therapy before quitting smoking is called nicotine preloading. Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking (quit day) aiming to reduce withdrawal symptoms and craving. However, other, more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after. Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward. A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed.This is a study protocol for a multicenter, non-blinded, randomized controlled trial based in the United Kingdom, enrolling 1786 smokers who want to quit, funded by the National Institute for Health Research, Health Technology Assessment program, and sponsored by the University of Oxford. Participants will primarily be recruited through general practices and smoking cessation clinics, and randomized (1:1) either to use 21 mg nicotine patches, or not, for four weeks before quitting, whilst smoking as normal. All participants will be referred to receive standard smoking cessation service support. Follow-ups will take place at one week, four weeks, six months and 12 months after quit day. The primary outcome will be prolonged, biochemically verified six-month abstinence. Additional outcomes will include point prevalence abstinence and abstinence of four-week and 12-month duration, side effects, costs of treatment, and markers of potential mediators and moderators of the preloading effect.This large trial will add substantially to evidence on the effectiveness of nicotine preloading, but also on its cost effectiveness and potential mediators, which have not been investigated in detail previously. A range of recruitment strategies have been considered to try and compensate for any challenges encountered in recruiting the large sample, and the multicentre design means that knowledge can be shared between recruitment teams. The pragmatic study design means that results will give a realistic estimate of the success of the intervention if it were to be rolled out as part of standard smoking cessation service practice.Current Controlled Trials ISRCTN33031001. Registered 27 April 2012.

Project description:BACKGROUND:The impact of Goal Directed Fluid Therapy (GDFT) based on the non-invasive Pleth Variability Index (PVI) on clinical outcome after abdominal surgery has only sparingly been explored. The purpose of this study was to compare the effect of intraoperative GDFT guided by PVI to a control group using esophageal Doppler on the incidence of complications and length of hospital stay after major abdominal surgery. We hypothesized that there would be no difference between the groups. METHODS:This was a randomized controlled trial in a Swedish university hospital between November 2011 and January 2015; 150 patients scheduled for open abdominal surgery lasting 2 h or more were included. Exclusion criteria included hepatic resection or severe cardiac arrhythmia. The patients were randomized 1:1 to either the intervention group or the control group. The intervention group received intraoperative GDFT by administering fluid boluses of 3 ml/kg tetrastarch aiming at a PVI value below 10%, while GDFT in the control group aimed for optimization of stroke volume as assessed with esophageal Doppler. Blinded observers assessed complications until postoperative day 30 using pre-defined definitions, as well as length of hospital stay. RESULTS:One hundred and-fifty patients were randomized and 146 patients were available for the final data analysis. Median duration of surgery was 3 h. A total of 64 complications occurred in the PVI group (N?=?74) and 70 in the Doppler group (N?=?72) (p?=?0.93). Median (IQR) length of stay was 8.0 (8.0) days in the PVI group and 8.0 (9.5) in the Doppler group (P?=?0.57). CONCLUSIONS:No difference in clinical outcome, as defined by number of postoperative complications, and length of hospital stay, was found when goal directed fluid therapy was applied using PVI as an alternative to esophageal Doppler. PVI appears to be an acceptable alternative to esophageal Doppler for goal directed fluid therapy during major open abdominal surgery. TRIAL REGISTRATION:Clinicaltrials.gov NCT01458678 . Date of first registration October 20, 2011.

Project description:BackgroundPhotoplethysmography with a digital sensor (ClearSight, Edwards Lifesciences, Irvine, CA, USA) connected to a dedicated monitor (EV 1000, Edwards Lifesciences) was recently proposed for use in performing hemodynamic optimization during surgery. The objective of this study is to evaluate the effect of photoplethysmography on the incidence of postoperative complications compared with the conventional hemodynamic algorithm, which uses mean arterial pressure.Methods/designThe hemodynamic optimization using photoplethysmography (PANEX3) trial is a monocentric, randomized, single-blind, controlled, two parallel arm, superiority trial, randomizing 160 patients with an intermediate risk of postoperative complications after colorectal surgery. Informed consent will be obtained from all participants. The hemodynamic optimization is conducted using a specified hemodynamic algorithm either with photoplethysmography (the photoplethysmography group) or with conventional mean arterial pressure (the control group). The anesthesiologist performed a 1:1 randomization the day before surgery using a scratch card, which is available 24/7. The randomization sequence is generated using permutated blocks. Both the patients and surgeons are blinded to the allocation group. The primary outcome is the incidence of at least one postoperative complication during the 30 days following surgery. Two independent experts, who were blinded to the group allocations, validate the complication for each patient using an a priori classification. The secondary outcomes are to study the total number of postoperative complications, the real length of hospital stays, and the postoperative mortality between each group.DiscussionThe PANEX3 trial is the first randomized controlled study conducted to investigate whether perioperative hemodynamic optimization using photoplethysmography during colorectal surgery could decrease the incidence of patients having at least one postoperative complication.Trial registrationClinicalTrials.gov Identifier: NCT02343601.

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BReastfeeding Attitude and Volume Optimization (BRAVO) trial: study protocol for a randomized controlled trial.

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BReastfeeding Attitude and Volume Optimization (BRAVO) trial: study protocol for a randomized controlled trial.

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