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.
This is an open-label, randomized, 2-arm clinical trial in healthy infants in Bangladesh. The primary purpose of the study is to assess the immunogenicity of measles-rubella (MR) vaccine when delivered at 6 months. In addition, the study will establish the equality of MR vaccine seroconversion administered at 9 months following administration of an earlier MR vaccine dose at 6 months of age compared to MR vaccine dose administered at 9 months without previous MR vaccination. This study will also provide additional data on safety and tolerance of MR vaccine given at 6 months, and impact of maternal antibodies on immunogenicity of MR vaccine at 6 months. - Primary objectives: 1. To assess immunogenicity of MR vaccine at 6 months of age 2. To assess immunogenicity of MR vaccine at 9 months of age among children without prior measles and rubella vaccination, compared with MR vaccine immunogenicity among those who had a prior MR vaccination at 6 months of age - Secondary objectives 1. To assess the frequency of adverse reactions following administration of MR vaccine at 6 months 2. To compare the immunogenicity of the MR vaccine first dose administered at 6 months vs at 9 months. 3. To assess the proportion of mothers with undetectable, detectable and protective levels of measles and rubella antibodies 4. To determine the extent of variation in measles antibodies in women of child bearing age in a population with a long standing measles vaccination program 5. To determine the extent of variation in rubella antibodies in women of child bearing age in a population where rubella vaccine have been recently introduced 6. To determine if variation in antibody levels in infants at 6 months is predominately explained by variation in starting antibody levels in the mother in this population 7. To estimate the half-life of decay of measles and rubella antibodies in infants
Background (brief): 1. Burden: The uniqueness of each child is tremendously influenced by interaction between nature and nurture during critical period of brain development that promotes foundation of brain architecture through neuronal connections. 2. Knowledge gap: Young children in Bangladesh are prone to multiple physiological and psycho-social risk factors e.g. poverty, maltreatment, malnutrition, disease, parental illiteracy, maternal depression and lack of stimulation, all of which are preventable. Little is reported about any comprehensive package of development that addresses most of these early childhood risks and promotes optimum early childhood development (ECD). 3. Relevance: The aim of this study is to develop and evaluate an integrated, low cost, and feasible center based approach that focuses on positive parenting of children during early life that will promote early stimulation, minimize childhood maltreatment, boost up of maternal self-esteem and healthy thinking and improve health and nutritional (HN) status of children. Hypothesis (if any): This integrated intervention will promote maternal child-care practices and mental health that will finally improve their children's growth, micro-nutrient status, early brain development compared to control group. Objectives: To see the effect of an integrated intervention (ECD + HN) on growth, micro-nutrient status, child development along with effect on maternal child-care practices and mental health. Methods: Randomly selected 2 groups will be identified as intervention and control (150 mothers' from15 clusters in each group). Mothers of 8-23 months old children living in slums and practice harsh child-disciplining will be identified as study population. The mothers of intervention (ECD+HN) group will receive fortnightly group sessions for 11 months that will include combined messages on a) psycho-social stimulation, b) positive parenting to prevent child maltreatment and c) cognitive behavioral therapy (CBT) for positive thinking, d) health and nutrition messages and e) 15 micro-nutrient sprinkle supplement.(90 sachets of over 6 month-period). The control group will only receive the usual health messages provided by the government. Outcome measures/variables: - Children's cognitive, motor, language and socio-emotional development; anthropometry; hemoglobin and micro-nutrient status (serum vitamin B12, iron and folic acid) - Mother s' parenting practices, depressive symptoms, self-esteem and child-maltreatment.
Infant feeding practices and nutritional status among children is interrelated and link is well established. Incidence of malnutrition sharply rises during 6-9 months of age in most of the developing countries which coincide with the period of complimentary feeding (CF). This prospective randomized trial will be implemented in ongoing health and demographic surveillance system of Matlab, ICDDR,B and will be nested into an ongoing maternal and child health services area. Area of community health workers (four blocks) will be divided into two pairs and each pair will be randomly assigned into intervention or control groups. The eligible and consented mother-infant newborn will be recruited either into an intervention or control groups based on the areas of the paired block. The mothers and family members of the intervention area will receive intensive counseling on complementary feeding practices through community health workers. In total about 360 mother-infant pair will be recruited in the study for each site. Data on children's anthropometry (weight and lengths), information on complementary feeding practices and related covariates will be collected through trained research staffs. Data will be evaluated on reduction of burden of malnutrition (stunting, underweight, wasting) and complimentary feeding index between intervention and control groups.
The study compares two lengths of medication therapy (a shortened versus a prolonged dual antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the successfully treatment for coronary heart disease with a drug covered stent (metallic tube). This comparison will be done in patients who, compared to the average patient, are more likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are within the current medical recommendations. The aim of this study is to help improve further standard antiplatelet duration guidelines.
Background: There is no reliable method for vitamin A (VA) assessment for infants and young children. Serum VA concentration is not an authenticate indicator of VA status, while existing deuterium- VA isotope dilution methods to determine the whole body VA status require 3 weeks and not applicable for infants and children. The investigator's research group recently developed a new simplified equation to measure VA pool size in 4-5 days, correlated with compartmental model-predicted value and estimate VA pool size in adults with high precision. In this study, we validate the method in healthy infants and infants with an inflammatory condition. Hypothesis: Whole-body VA status in infant and children can be estimated without accounting for the fractional catabolic rate in the context of an inflammatory condition Specific Objectives: In this study, the investigators propose to determine the early time point equation for assessing VA pool size in infants with or without inflammatory condition using model-based compartmental analysis from the fraction of oral dose-derived 13C10-VA and 13C4-VA in plasma over time. Methods: A total of 183 infants (9-18 mo of age) will participate in this study in the following two phases of the "Super Kid study" that ensure no more than 2 venous blood samples from each infant, even though multiple time points (at least 4 subjects / time-point) over a 28-day study period will be available for mathematical modeling. In this study, investigators will use two different stable isotopic vitamin A e.g., 13C10-retinyl acetate and 13C4-retinyl acetate. 400 μg of these isotopes, dissolved in 0.5 mL of sunflower oil, will be provided directly into the infant's mouth by using a direct replacement pipette. Mothers will be asked to breastfeed their infant after oral dosing to enhance absorption of the labeled vitamin A. Specific activity of 13C10- and 13C4- retinyl acetate in the blood samples will be measured by liquid chromatography-tandem mass spectrometry (LC/MS/MS). Dietary and morbidity questionnaires will be used. Investigators will also use PENTA vaccines as a means to induce controlled inflammation (closely mimic to natural infection). PENTA is a combination of five different vaccine antigens (Hepatitis B (HBV)/ Haemophilus influenza type b (Hib) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)). This vaccination is beneficial to the infants since the World Health Organization recommends a booster vaccination dose. At the end of the study, PENTA vaccines will also be provided to the study infants in the "no-vaccine" group. (A) 115 infants will be enrolled randomly into 16 groups of them 40 infants will be in the first group, while other infants will be assigned in the other 15 groups (n=5/group). On day 0 (at 0h), all infants (n=115) will receive an oral dose of 13C10-retinyl acetate. Blood samples (5 mL) will be taken from 6h to 16th day of dosing at 9 different time-points. On day 16 (at 0h), randomly selected 50% infants (n=20) in the first group, as well as 30 infants in the other 6 groups, will receive PENTA vaccines, while the other 50% infants (n=20) in the first Group, as well as 45 infants in the other 9 groups, will receive no vaccines. 24 hours after vaccination (On day 17) a finger-prick blood sample will be obtained from the infants in the vaccinated group to measure CRP (QuikRead go, Orion, Finland). Infants who do not develop inflammation (CRP> 5mg/L) after PENTA vaccination will be excluded from the study. On day 17 (at 0h), all infants (n=115) will receive another oral dose of 13C4-retinyl acetate. Blood samples (5mL) will be collected from day 16 to day 28 at 11 different time-points for each of the vaccinated and non-vaccinated infants. This study will also assess the absorption of isotopic retinol by determining in total excreted stool up to 72 h post isotope dosing in a subsample of infants (B) 68 infants will be enrolled in this phase. Of them, 28 infants will be assigned randomly into 7 groups (n=4/group). They will receive PENTA vaccines on day -1, and the next day (day 0) they will receive an oral dose of 13C4-retinyl acetate. Blood samples (5mL) will be collected from day 1 to day 28 at 8 different time points. In a separate design, 40 infants will receive an oral dose of 13C10-retinyl acetate on day 0 and blood samples (5mL) will be collected on day 4. On day 7 they all will receive another oral dose of 13C4-retinyl acetate (400 μg, dissolved in 0.5 mL of sunflower oil). On day 10, infants will receive PENTA vaccines (n=30) or no vaccine (n=10) and 1-day after vaccination, blood samples (5 mL) will be obtained from infants who develop inflammation (CRP> 5mg/L) in the vaccine group and also from infants in the control group (day 11). Outcome measures: The early time point equation for assessing VA pool size in a group of infants with or without inflammation
Rotavirus is the leading cause of diarrhea in children worldwide. Oral rotavirus vaccines work remarkably well in high-income countries, but for unclear reasons they underperform in low-income countries. A double-blind, randomized control trial will be performed to evaluate whether using a higher dose of a currently licensed vaccine (Rotarix, GlaxoSmithKline) can improve immune responses among infants in Dhaka, Bangladesh. Infants will be randomized 1:1 to receive either a standard or a double dose of Rotarix at 6 and 10 weeks of life. Infants will be assessed for fecal vaccine shedding and serum rotavirus-specific IgA responses to determine vaccine immunogenicity.
This study is to test the usability of a new pulse oximeter probe designed for children 0-5 years.
This is a research study of an experimental (investigational) live attenuated Shigella sonnei vaccine (WRSS1) to find a dose of the vaccine that is safe, tolerable, and develops an immune response. Shigella causes bloody and watery diarrhea, and infants and children living in developing countries experience the greatest consequences of this disease.
This study will be conducted to evaluate the effect of vitamin B12 and vitamin B6 in delaying the onset and reducing the incidence and severity of Vincristine Induced Peripheral Neuropathy (VIPN) in Acute Lymphoblastic Leukemia (ALL) patient.
The purpose of this community-based randomized controlled trial is to test whether the mCARE-II intervention package, delivered by the existing Government of Bangladesh community health workforce, will improve neonatal and perinatal survival in a rural setting in northwestern Bangladesh. mCARE-II is a digital health intervention, which incorporates automated workload scheduling, client prioritization and risk stratification, overdue service reminders and demand generation through client side reminder messaging. The intervention package focuses on the pregnancy and early postpartum period.