scholarly journals Neonatal azithromycin administration to prevent infant mortality: study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e031162 ◽  
Author(s):  
Ali Sie ◽  
Mamadou Bountogo ◽  
Eric Nebie ◽  
Mamadou Ouattara ◽  
Boubacar Coulibaly ◽  
...  
Keyword(s):  
Single Dose ◽  
Randomised Controlled Trial ◽  
San Francisco ◽  
Child Mortality ◽  
Controlled Trial ◽  
Hypertrophic Pyloric Stenosis ◽  
Institutional Review Boards ◽  
Infantile Hypertrophic Pyloric Stenosis ◽  
All Cause Mortality ◽  
Randomised Controlled

IntroductionBiannual mass azithromycin distribution to children aged 1–59 months has been shown to reduce all-cause mortality. Children under 28 days of age were not treated in studies evaluating mass azithromycin distribution for child mortality due to concerns related to infantile hypertrophic pyloric stenosis (IHPS). Here, we report the design of a randomised controlled trial to evaluate the efficacy and safety of administration of a single dose of oral azithromycin during the neonatal period.Methods and analysisTheNouveaux-nés et Azithromycine: une Innovation dans le Traitement des Enfants(NAITRE) study is a double-masked randomised placebo-controlled trial designed to evaluate the efficacy of a single dose of azithromycin (20 mg/kg) for the prevention of child mortality. Newborns (n=21 712) aged 8–27 days weighing at least 2500 g are 1:1 randomised to a single, directly observed, oral dose of azithromycin or matching placebo. Participants are followed weekly for 3 weeks after treatment to screen for adverse events, including IHPS. The primary outcome is all-cause mortality at the 6-month study visit.Ethics and disseminationThis study was approved by the Institutional Review Boards at the University of California, San Francisco in San Francisco, USA (Protocol #18-25027) and the Comité National d’Ethique pour la Recherche in Ouagadougou, Burkina Faso (Protocol #2018-10-123). The findings of this trial will be presented at local, regional and international meetings and published in open access peer-reviewed journals.Trial registration numberNCT03682653; Pre-results.

scholarly journals Single-dose versus 7-day-dose metronidazole for the treatment of trichomoniasis in women: an open-label, randomised controlled trial

2018 ◽  
Vol 18 (11) ◽  
pp. 1251-1259 ◽  
Author(s):  
Patricia Kissinger ◽  
Christina A Muzny ◽  
Leandro A Mena ◽  
Rebecca A Lillis ◽  
Jane R Schwebke ◽  
...  
Keyword(s):  
Single Dose ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Open Label ◽  
Randomised Controlled

scholarly journals ‘Reducing Delays In Vaccination’ (REDIVAC) trial: a protocol for a randomised controlled trial of a web-based, individually tailored, educational intervention to improve timeliness of infant vaccination

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e027968 ◽  
Author(s):  
Amanda F Dempsey ◽  
Nicole Wagner ◽  
Komal Narwaney ◽  
Jennifer Pyrzanowski ◽  
Bethany M Kwan ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Vaccination Status ◽  
Institutional Review Boards ◽  
Vaccine Preventable Diseases ◽  
Infant Vaccination ◽  
The Usa ◽  
Secondary Outcomes ◽  
Randomised Controlled ◽  
The University

IntroductionIncreasing numbers of children are failing to receive many recommended vaccines, which has led to significant outbreaks of vaccine-preventable diseases in the USA and worldwide. A major driver of undervaccination is parental vaccine hesitance. Prior research demonstrates that mothers are the primary decision maker for infant vaccination, and that their vaccination attitudes form primarily during pregnancy and early in their infant’s life.Methods and analysisThis manuscript describes the protocol for an ongoing three-armed randomised controlled trial done at Kaiser Permanente Colorado (KPCO). The trial aims to test the efficacy of provided tailored, individualised information via the Internet to pregnant and new mothers versus untailored information versus usual care on the timeliness of infant vaccination. The primary outcome to be assessed is vaccination status, which is a dichotomous outcome (up to date vs not) assessed at age 200 days, reflecting the time when infants should have completed the first set of vaccine provided (at age 2, 4 and 6 months). Infants with one or more age-appropriate recommended vaccines at least 30 days delayed are categorised as not up to date whereas all other infants are considered up to date. Secondary outcomes include vaccination status at age 489 days, reflecting receipt of recommended vaccines at age 12–15 months, as well as vaccination attitudes, hesitancy and intention. Vaccination data will be derived from the electronic medical record and the state immunisation registry. Other secondary outcomes will be assessed by online surveys.Ethics and disseminationThe study activities were approved by the Institutional Review Boards of the University of Colorado, KPCO and the University of Michigan. Results will be disseminated through peer-reviewed manuscripts and conference presentations.Trial registration numberNCT02665013; Pre-results.

scholarly journals Rationale and design of the HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) Trial: a protocol for an international randomised controlled trial evaluating early surgery for hip fracture patients

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e028537 ◽  
Author(s):  
Flavia K Borges ◽  
Mohit Bhandari ◽  
Ameen Patel ◽  
Victoria Avram ◽  
Ernesto Guerra-Farfán ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Hip Fracture ◽  
Randomised Controlled Trial ◽  
Standard Care ◽  
Perioperative Complications ◽  
Public Awareness ◽  
Controlled Trial ◽  
Early Surgery ◽  
All Cause Mortality ◽  
Randomised Controlled

IntroductionAnnually, millions of adults suffer hip fractures. The mortality rate post a hip fracture is 7%–10% at 30 days and 10%–20% at 90 days. Observational data suggest that early surgery can improve these outcomes in hip fracture patients. We designed a clinical trial—HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) to determine the effect of accelerated surgery compared with standard care on the 90-day risk of all-cause mortality and major perioperative complications.Methods and analysisHIP ATTACK is a multicentre, international, parallel group randomised controlled trial (RCT) that will include patients ≥45 years of age and diagnosed with a hip fracture from a low-energy mechanism requiring surgery. Patients are randomised to accelerated medical assessment and surgical repair (goal within 6 h) or standard care. The co-primary outcomes are (1) all-cause mortality and (2) a composite of major perioperative complications (ie, mortality and non-fatal myocardial infarction, pulmonary embolism, pneumonia, sepsis, stroke, and life-threatening and major bleeding) at 90 days after randomisation. All patients will be followed up for a period of 1 year. We will enrol 3000 patients.Ethics and disseminationAll centres had ethics approval before randomising patients. Written informed consent is required for all patients before randomisation. HIP ATTACK is the first large international trial designed to examine whether accelerated surgery can improve outcomes in patients with a hip fracture. The dissemination plan includes publishing the results in a policy-influencing journal, conference presentations, engagement of influential medical organisations, and providing public awareness through multimedia resources.Trial registration numberNCT02027896; Pre-results.

scholarly journals Single dose v two‐dose antenatal anti‐D prophylaxis: a randomised controlled trial

2019 ◽  
Vol 211 (6) ◽  
pp. 261-265 ◽  
Author(s):  
Scott W White ◽  
Janice C Cheng ◽  
Blagica Penova‐Veselinovic ◽  
Carol Wang ◽  
Melanie White ◽  
...  
Keyword(s):  
Single Dose ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Randomised Controlled

scholarly journals Integrated Sustainable Childhood Pneumonia and Infectious Disease Reduction in Nigeria (INSPIRING) Through Whole System Strengthening in Jigawa, Nigeria: Study Protocol For a Cluster Randomised Controlled Trial

2021 ◽  
Author(s):  
Carina King ◽  
Rochelle Burgess ◽  
Ayobami Bakare ◽  
Funmilayo Shittu ◽  
Julius Salako ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Health System ◽  
Child Mortality ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Health System Strengthening ◽  
Economic Evaluations ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
Whole Systems

Abstract BackgroundChild mortality remains unacceptably high, with Northern Nigeria reporting some of the highest rates globally (e.g. 192/1000 live births in Jigawa State). Coverage of key protect and prevent interventions, such as vaccination and clean cooking fuel use, are low. Additionally, knowledge, care-seeking and health system factors are poor. Therefore, a whole systems approach is needed for sustainable reductions in child mortality.MethodsThis is a cluster randomised controlled trial, with integrated process and economic evaluations, conducted from January 2021 – September 2022. The trial will be conducted in Kiyawa Local Government Area, Jigawa State, Nigeria, with an estimated population of 230,000. Clusters are defined as primary government health facility catchment areas (n=33). The 33 clusters will be randomly allocated (1:1) in a public ceremony, and 32 clusters included in the impact evaluation. The trial will evaluate a locally adapted ‘whole systems strengthening’ package of three evidence-based methods: community men’s and women’s groups; Partnership Defined Quality Scorecard; healthcare worker training, mentorship and provision of basic essential equipment and commodities. The primary outcome is mortality of children aged 7 days to 59 months. Mortality will be recorded prospectively using a cohort design, and secondary outcomes measured through baseline and endline cross-sectional surveys. Assuming the following, we will have a minimum detectable effect size of 30%: a) baseline mortality of 100 per 1000 livebirths; b) 4,480 compounds with 3 eligible children per compound; c) 80% power; d) 5% significance; e) intra-cluster correlation of 0.007; f) coefficient of variance of cluster size of 0.74. Analysis will be by intention-to-treat, comparing intervention and control clusters, adjusting for compound and trial clustering. DiscussionThis study will provide robust evidence of the effectiveness and cost-effectiveness of community-based participatory learning and action, with integrated health system strengthening and accountability mechanisms, to reduce child mortality. The ethnographic process evaluation will allow for a rich understanding of how the intervention works in this context. However, we encountered a key challenge in calculating the sample size, given the lack of timely and reliable mortality data, and the uncertain impacts of the COVID-19 pandemic. Trial registrationISRCTN 39213655, registered 11th December 2019

scholarly journals Baseline Demographics Of Cow’s Milk Allergic Infants Recruited To A Randomised Controlled Trial Of Single-Dose Challenge With Cow’s Milk

2019 ◽  
Vol 143 (2) ◽  
pp. AB162
Author(s):  
Yvonne M. d'Art ◽  
Aideen M. Byrne ◽  
John Fitzsimons ◽  
Audrey DunnGalvin ◽  
Jonathan O'B. Hourihane
Keyword(s):  
Single Dose ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cow’S Milk ◽  
Cow's Milk ◽  
Randomised Controlled

scholarly journals Transmission reduction and prevention with HPV vaccination (TRAP-HPV) study protocol: a randomised controlled trial of the efficacy of HPV vaccination in preventing transmission of HPV infection in heterosexual couples

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e039383
Author(s):  
Aaron MacCosham ◽  
Mariam El-Zein ◽  
Ann N Burchell ◽  
Pierre-Paul Tellier ◽  
François Coutlée ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Hpv Vaccine ◽  
Controlled Trial ◽  
Hpv Vaccination ◽  
Hpv Infection ◽  
Institutional Review Boards ◽  
Heterosexual Couples ◽  
Transmission Reduction ◽  
Hpv Types ◽  
Randomised Controlled

IntroductionHuman papillomavirus (HPV) is a causal agent of malignancies including cervical, vulvar, vaginal, penile, anal and oropharyngeal cancer, as well as benign conditions such as anogenital warts. HPV vaccination protects individuals against infections with the target HPV types and their clinical outcomes. However, little is known about the protection an immunised individual confers to their sexual partner or its impact on HPV transmission dynamics. In this context, the Transmission Reduction and Prevention with HPV vaccination (TRAP-HPV) study was designed to determine the efficacy of an HPV vaccine in reducing transmission of genital and oral HPV infection in sexual partners of vaccinated individuals.Methods and analysisThe TRAP-HPV study is an ongoing randomised controlled trial among heterosexual couples living in Montreal, Canada. Sexually active couples, aged between 18 and 45 years, who have been in a relationship no longer than 6 months are considered eligible. Participants are independently randomised to receive either the intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention–intervention, intervention–placebo, placebo–intervention and the placebo–placebo. Participants provide genital (vaginal/penile) and oral samples at baseline and five follow-up visits over a 1-year duration. Linear Array HPV genotyping is used to detect 36 HPV types. Cox proportional hazard regression models will be used to estimate the effect of vaccination on HPV transmission.Ethics and disseminationThe TRAP-HPV study received ethical approval by institutional review boards McGill University, Concordia University and Centre Hospitalier de l’Université de Montréal. Before enrolment, all participants provide informed written consent. Results will be published in peer-reviewed journals and presented at national and international conferences. The generated empirical evidence could be used in mathematical models of vaccination to inform policymakers in Canada and elsewhere.Trial registration numberNCT01824537.

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