There are about 620 clinical studies being (or have been) conducted in Bangladesh. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Continuous Positive Airway Pressure (CPAP) is a common form of support for patients admitted to Intensive Care Units (ICUs) of industrialized countries with respiratory distress (1). Nasal CPAP (NCPAP) is effective in correcting hypoxemia and contributes to reducing the number of children requiring endo-tracheal intubation and mechanical ventilation (2). CPAP is most frequently delivered to neonates using conventional mechanical ventilators, and thus there is minimal or no cost saving. There are other ways of delivering CPAP, such as Bubble-CPAP, which requires a source of gas flow (typically 6-8 L/ minute in a neonate), an air-oxygen blender, a humidifier and a T-piece.(3). The expiratory arm is inserted in a bottle of water and the level of CPAP delivered is equivalent to the length of the expiratory tubing that remains under water. Robust equipment is now available at a fraction of the cost of mechanical ventilators. Bubble-CPAP has potential advantages over the mechanical ventilation, such as lower cost, ease of application by nursing staff, lower risk of complications, and has been proposed as an inexpensive method of delivering CPAP in developing countries (3). High flow air/oxygen mix is useful in reducing the indication of mechanical ventilation (4); however, there is a lack of randomized studies comparing it with bubble CPAP or with standard flow O2 supplementation by nasal prongs. High flow air/oxygen mix uses flows of 2 litre per kg per minute of blended air/oxygen mix, usually with a low fraction of inspired oxygen (say 25-40%). It is easy to apply, but requires additional equipment to standard oxygen therapy, and closer monitoring. "High flow" delivers uncertain levels of CPAP, so it is not clearly superior to bubble-CPAP, and there have been no controlled comparative trials of these two techniques. Pneumonia and malnutrition are two of the most common co-morbidities in children in developing countries (5). In hospitals in resource-poor settings, children with severe malnutrition and pneumonia often present with respiratory distress with or without severe hypoxaemia and impending respiratory failure (6). They initially receive O2 supplementation through nasal prong or face mask. Support from bubble CPAP might help to effectively treat hypoxaemia, improve respiratory function, avoid the need for mechanical ventilation and its complications, and reduce mortality. Almost half of the patients admitted in the intensive care unit of the Dhaka hospital of ICDDR,B present with hypoxaemia, many with impending respiratory failure. Children with pneumonia also invariably have severe malnutrition with or without diarrhoea (Chisti MJ, MMed thesis, unpublished data). They often need mechanical ventilation, with attendant costs, complications and high mortality rates. However, no published data are available about the use of bubble-CPAP in children with pneumonia and malnutrition and there have been no controlled trials of CPAP in developing countries. The Hypothesis is: In children with severe pneumonia and hypoxaemia the probability of treatment failure (see definition below) will be significantly lower when respiratory support is initially provided by bubble-CPAP or high-flow, humidified air/O2 mix by nasal prongs, compared to standard oxygen flow.
The purpose of this two part study is to test the safety and efficacy of Tafenoquine (with Cholorquine) as a radical cure for Plasmodium vivax (P.vivax) malaria relative to the control Chloroquine.Part 1 aims to select an efficacious and well tolerated dose that can be co-administered with Chloroquine. Part 2 will investigate the safety and efficacy of the selected dose (300 mg tafenoquine) in the treatment and radical cure of Plasmodium Vivax Malaria.
Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breastmilk antibodies, changes in gut microbiota, and genetic susceptibility. Primary Objective: to determine whether tropical enteropathy impairs the efficacy of oral polio and rotavirus vaccines in children in Bangladesh. Secondary Objectives: 1) to determine the impact of an inactivated polio vaccine (IPV) boost on the efficacy of oral polio vaccine and 2) to determine the efficacy of oral rotavirus vaccine to prevent rotavirus diarrhea The polio and rotavirus randomized clinical trials are embedded as secondary objectives within the exploratory study of tropical enteropathy. The primary and secondary outcome measures are relevant to the randomized clinical trials.
A randomized controlled trial to assess the safety and efficacy of azithromycin combination therapy for use in severe malaria. This pilot trial will be conducted in uncomplicated malaria patients in southeastern Bangladesh.
Because the artemisinins are the most potent antimalarial drugs, the reduction in parasite numbers is rapid. Therefore, early measures of reducing parasite counts are needed. This study will look at conventional markers of parasite reduction e.g. parasite clearance time, parasite reduction ratio, and the time to achieve a fall of 50%, 90% and 99% of the pre-treatment parasitaemia. Defining artemisinin resistance requires the use of artesunate (AS) alone because it is now appreciated that the partner drug in a combination treatment has a significant impact on the rate of parasite clearance. This study will dose patients for 3 days with AS alone (or longer until parasites clear) and measure the parasite count frequently in order to be able to define an accurate regression line of a graph of the natural logarithm of the parasite count (Y axis) versus time (X axis). This will be followed by a full course of an artemisinin combination therapy (ACT). Two different dose regimens of artesunate will be compared at all sites except those in western Cambodia, as unpublished observations from the Thai-Myanmar border suggest the standard lower daily dose of 2mg/kg may enable the earlier detection of low level resistance than a 4mg/kg daily dose.
When shallow tubewells replaced highly contaminated surface water as the primary source of drinking water in Bangladesh in the late 20th century, contemporary studies demonstrated no reduction in diarrheal disease with this improvement in water source. This lack of improvement in transitioning to tubewells is consistent with the lack of significant health gains observed in intervention studies focusing on water quality improvements at the source. In contrast, high quality intervention studies that improve water quality at the point of use through treatment of water in households show a 39% reduction in diarrhea. The primary objective of this study is within a typical setting in rural Bangladesh where households use shallow tubewell water for drinking. The investigators will randomly assign 1800 households who have a child between the ages of six months and two years to one of three groups. Group 1 will receive a safe water storage vessel with a lid and a narrow mouth/tap and Aquatabs, an effervescent water purification tablet that utilizes sodium dichloroisocyanurate (NaDCC) as the chlorine donor. Group 2 will only receive a safe water storage vessel with a lid and a narrow mouth/tap. Group 3 will receive no water intervention and continue their standard habits and practices. Every month a field research assistant will visit each participating household and collect information on the prevalence of diarrhea among children between the ages of six months and two years, as well as children between the ages of two and five years if present in the household. Diarrhea prevalence in the 48 hours and 7 days preceding the visit will be recorded. The investigators will compare the longitudinal prevalence of diarrhea between the following groups: (1) households that receive chlorine and storage container versus households that only receive storage container to assess the effect of chlorination, (2) households that only receive storage container versus households that receive no intervention to assess the effect of safe storage, and (3) households that receive chlorine and storage container versus households that receive no intervention to assess the combined effect of chlorination and safe storage. Hypothesis: Drinking water from shallow tubewells that are intermittently contaminated with enteric pathogens contributes importantly to diarrhea among children in rural Bangladesh.
a. To measure the amount of zinc absorbed from ZnBfR compared with the amount absorbed from CR and from CR fortified with added zinc, using the triple stable isotope tracer ratio technique in young children. Methods: Investigators will measure the amount of zinc absorbed from ZnBfR compared to that absorbed from a conventional Bangladeshi rice (Diet-CR) (control). They will also compare the zinc absorption from ZnBfR with that from zinc-fortified conventional rice (Diet-CR+Z). The study will be a cross-over, randomized, controlled clinical study. Forty-four children aged 36-59 mo of either sex will be recruited from the same community as mentioned before, and participants will be individually randomized, in equal numbers, to one of the two comparison groups, A and B. During an initial one-day acclimatization period, the participants will receive the conventional rice-based diet three times a day, to confirm that participants will accept the study diets and adhere to the study procedures. On study days 2 and 4, in comparison group A, participants will receive either the Diet-ZBfR or Diet-CR based on the random assignments, and participants will receive Diet-CR or Diet ZBfR, respectively, on days 3 and 5 (i.e., the diet not received on days 2 and 4), Likewise, in comparison group B, the participants will receive either Diet-ZBfR or Diet-CR+Z on days 2 and 4 based on the random assignments, and participants will receive Diet-CR+Z or the Diet-ZBfR, respectively, on days 3 and 5 (i.e., the diet not received on days 2 and 4). Investigators will use zinc stable isotope tracer techniques to measure the fractional absorption of zinc, in which tracer:tracee ratios will be measured in spot urine samples following administration of an intravenously administered tracer (68Zn) and one of two oral tracers (70Zn, 67Zn) provided with test meals over a four-day period. Outcome measures/variables: Intake of total dietary zinc (TDZ) and phytate for each subject will be calculated during the clinical study. Fractional absorption of zinc (FAZ) will be determined from the isotopic ratios obtained in urine samples using the following equation, which shows, as an example, the calculation that will be used for zinc absorption from the diet traced with 67Zn: FAZ = 67Zn tracer:tracee ratio / 68Zn tracer:tracee ratio * (68Zn dose given IV / 67Zn dose given orally) Total absorbed zinc (TAZ) for each child will be calculated as follows: TAZ (mg/d) = TDZ (mg/d) * FAZ
The purpose of this study is to conduct and evaluate the feasibility and effectiveness of a mass cholera vaccination program to reduce diarrhea due to Vibrio cholerae in a high incidence urban area. This study will also evaluate the feasibility of adding a household hand washing and safe drinking water promotion intervention to a cholera vaccine program and the overall impact of this combination on decreasing the incidence of diarrhea due to Vibrio cholerae.
Child undernutrition remains a highly prevalent condition in low and middle income countries and a major portion of the global burden of childhood malnutrition is found in South Asia with an estimated 74 million children living with chronic malnutrition (stunted growth) in this region. This burden of malnutrition accounts for approximately 50% of under five child deaths in developing countries. The risk of child death is also related to the severity of malnutrition and progressively increases the more the child's growth deviates from WHO Growth Standard, e.g. children with height-for-age <-3 Z scores from the standard have a four fold increased mortality risk compared to children within one Z score of the growth standard mean. Underweight in children for 18.7% of the global disability-adjusted life years in children less than five years of age. Childhood malnutrition is a pervasive problem in Bangladesh with 43% of children less than five years stunted in 2004 and 38% in urban child populations. An establish approach to promoting appropriate breastfeeding practices is through the use of local peer counsellors to provide information and to support to mothers. A recent study has conducted on pioneering research on this approach in Bangladesh.. The main aim of the study is to use a Cluster Randomized Control Trial (CRCT) to collect high-level evidence of whether peer counselling of women to promote appropriate breastfeeding and complementary feeding can improve feeding practices, child growth and reduce the prevalence of malnutrition in their children. The investigators will use a community-based Cluster Randomized Control Trial (CRCT) to examine the impact of a peer counselling infant feeding education program starting in the third trimester of pregnancy to one year after delivery, to improve child feeding practices, child growth and reduce the prevalence of malnutrition in their children. This will result in two study groups. The outcome assessments will be made on a cohort of infant-mother dyads measured at baseline and at follow up visits because the investigators expect a likely high correlation between baseline and follow up outcome measures, thus making this approach the most efficient study design. Outcome assessments will be conducted with all the mother-infant pairs recruited in the community clusters in the study, with an expected total of 1950 mother-infant days (975 in each treatment group). The peer counseling education will be offered to eligible pregnant women identified by household surveys over 3 months in each community cluster in the intervention group. Using a similar approach to recruitment, a cohort of mother-infant dyads, who will receive standard maternal and child health care programs, will be identified in the control clusters. Data will be collected on anthropometry, feeding practices and hygiene and caring practices etc. The investigators will report the results for 2-sided 5% tests for the primary trial outcome. Secondary analyses will examine each outcome variable (stunting, height-for-age, feeding patterns, and mean nutrient intakes) taking account of the repeated measurements within children by using separate mixed models. The investigators will use linear mixed models for continuous outcomes (e.g. height-for-age Z) and generalized linear mixed models for non-continuous outcomes (e.g. logistic mixed models for binary outcomes e.g. percentage exclusively breastfeeding). It is expected that the publications from this research will have substantial impact on child health and will help with the development of public health nutrition policies for children in South Asia and will be widely cited.
More than half of under-five deaths in Bangladesh occur in the first month of life (neonatal period), and a substantial proportion of these deaths are due to infections (sepsis). According to the recently formulated Bangladesh National Neonatal Health Strategy (NNHS), the Government of Bangladesh is committed to improve access to quality management of neonatal infections. The strategy emphasizes that health service providers at all levels acquire the skills for managing sepsis. Responding to the recommendations in the National Neonatal Health Strategy, this operations research seeks to evaluate alternative approaches for the management of neonatal sepsis in the community. The evaluation will focus on assessing intervention coverage, provider quality of care, and referral and referral compliance, and will undertake cost-benefit analysis of community-based neonatal sepsis management. The programme and evaluation will be within the existing health service delivery system in Bangladesh and is thus designed to inform the effective scaling up of neonatal sepsis management and contribute to the implementation of the NNHS. The interventions to be evaluated will be nested in the Maternal, Neonatal and Child Survival (MNCS) programme being implemented by the Government of Bangladesh, in partnership with and supported by UNICEF, and several national NGOs. This operations research is being implemented by the Government of Bangladesh in collaboration with UNICEF, SNL - Save the Children (USA), Bangladesh Perinatal Society, and ICDDR,B. It will take place in four MNCS programme upazilas, where 10 unions will be randomly selected for intervention and 10 unions will be comparison. The intervention consists of training of community health workers, village doctors and health facility workers on managing neonatal sepsis in addition to essential newborn care training. In the comparison areas the health workers will only receive essential newborn care training. The intervention and evaluation will continue for at least 18 months, with rolling surveys and two special surveys at 6 and 12 months into the project. The rolling surveys will look at intervention coverage, care-seeking, and referral and referral compliance, while the two special surveys will assess provider performance, referral compliance, and quality of care. In addition, the investigators will document implementation processes to understand what worked and what did not and why.