134 Clinical Trials for Various Conditions
The purpose of this study is to test various ways to help toddlers develop healthy eating and activity behaviors. Parents and toddlers, who participate in this research will be randomly assigned to either 1) continue their lifestyle behaviors for 10-weeks and then receive a health club membership for 1-month, 2) attend a health promotion playgroup together for 10 weeks, or 3) to attend an educational class for parents while toddlers are in childcare for 10-weeks. Physical measures of toddlers (height, weight, dietary intake, activity) will be collected. Parent-report surveys with questions about parenting, toddler diet, toddler temperament, food security status, demographic qualities, and satisfaction with group assignment will be collected. Last, the interactions between parents and toddlers will be observed and assessed during short play tasks via Zoom. All measures will be collected immediately upon signing up for the study (week 0), 10-weeks later (post), and 24-weeks after signing up for the study.
The goal of this study is to determine the feasibility and acceptability of two food preference learning approaches for toddlers that could serve as alternatives to mere repeated exposure to new or previously disliked foods. The target population is toddlers who score higher on food fussiness. The study is a two-group randomized controlled trial. Families will be randomized to 1 of 2 study groups: associative conditioning, or the child tasting vegetables alongside a palatable dip, or modeling, in which the child and parent taste vegetables together. Both groups will attend two laboratory visits, one before and one after a 4-week exposure period, and will be asked to complete 8 vegetable tastings in accordance with their assigned condition across the 4 intervention weeks. Key questions to be addressed are: * summarizing the feasibility and acceptability of the intervention strategies * assessing whether children's liking and intake of the target food increase from baseline to post-intervention
Young children rely on their foods and drinks for the nutrients they need to grow, like energy, protein, vitamins, and minerals. In addition to nutrients, there are substances in fruits, vegetables, milk and formula, called phytochemicals, that can support health. While researchers know more about the role of phytochemicals in adult health, researchers know surprisingly little about how phytochemicals can support health in young children. One group of phytochemicals are called the carotenoids. Carotenoids are responsible for the red, orange, and yellow colors in some fruits and vegetables. In adults, carotenoids can support visual function. Researchers also know that measuring levels of carotenoids in the blood or optically in the skin, can serve as an indirect measurement of what child and adults eat. The purpose of this study is to determine how a child's usual intake of carotenoids is related to their visual development and their blood and skin levels of carotenoids. The study involves 6 visits. For each visit, we will ask about the child's recent diet, will measure their body size, collect a blood sample, collect optical measurements of their skin, and will test how sharp their vision is.
The aim of the study is to investigate the growth of healthy toddlers fed with Toddler almond based nutritional drink (test) vs. a. formula that has been shown to support growth (control) in Healthy Toddlers
The purpose of the study is to train New York-based early childhood mental health consultants (ECMHCs) who will apply the Infant-Toddler Climate of Healthy Interactions for Learning and Development (I-T CHILD) tool as part of their standard practice. The study will evaluate I-T CHILD-informed early childhood mental health consultation in 100 New York State-licensed family day care and group family day care programs serving infants and toddlers in lower-income neighborhoods
Improving spoken language outcomes for children with hearing loss has important public health implications. This is a randomized clinical trial of 96 children with hearing loss that examines the effects of a parent-implemented early communication intervention on prelinguistic and spoken language outcomes. The study is open for national recruitment. Parents participate via video call with their child and receive technology to assist with virtual visits.
The goal of this study is to examine the effect of increasing children's intake of fiber and unsaturated fat, through daily servings of hummus and vegetables, on their microbiome profile.
The purpose of this study is to learn more about risk factors for autism by studying the behavior and brain functioning of toddlers with early communication delays and typically developing toddlers. Children 12 or 18 months of age with language delays (i.e., no words at 18 months, limited vocalizations at 12 months) and typically developing toddlers may be eligible to participate. This study will be conducted at the NIH Clinical Center in Bethesda, Maryland. There will be an initial screening evaluation that will include behavioral assessment. Eligible participants will then complete a baseline visit that includes an overnight sleep study that includes Electroencephalogram (EEG) test to measure brain electrical activity, and an MRI scan. Follow-up visits that include behavioral assessment will occur every 6-12 months, depending on age at study entry. The final study visit will occur at 36 months of age and will include behavioral assessment, sleep/EEG study, and MRI. There is no cost for participation. Compensation will be provided. To find out if your child qualifies or for more information, please call 301-451-7822 (TTY: 1-866-411-1010) or e-mail NIMH-ASD@mail.nih.gov. National Institute of Mental Health, National Institutes of Health, Department of Health \& Human Services.
This research is being done to test the effectiveness of an early intervention model for very young children at high risk for autism spectrum disorders (ASD) and their families. If children show improvement in this intervention, the investigators hope that the availability of public services of this type will be increased. Children between 11 months and 21 months old with Autism Spectrum Disorders, or with social and communication delays that indicate high risk for Autism Spectrum Disorders, and their parents may join the study. Treatment must start prior to the second birthday.
Background: Vitamin D plays a key role in calcium absorption in the gut and in skeletal development. Vitamin D deficiency is common, affecting an estimated one billion people worldwide, including developed countries. Vitamin D deficiency causes rickets, the most common non-communicable disease of childhood. Rickets causes poor growth and skeletal deformities and, at its most severe, seizures and death. Recent data suggest that children with rickets have an increased risk for developing diabetes mellitus. Screening for vitamin D deficiency is not commonly done. It is generally diagnosed only after symptoms of rickets have developed. Prevention and treatment is simple and inexpensive. Hence, early detection of vitamin D deficiency through screening would be beneficial. Studies are urgently needed to validate such screening tests. Calcium balance is tightly regulated in the body and calcium loss in the urine (measured by the urine calcium-to-creatinine ratio) is a sensitive indicator of reduced calcium absorption, such as in vitamin D deficiency. Objective and Hypotheses. The objective of this study is to evaluate the urine calcium-to-creatinine ratio as a noninvasive and inexpensive screening test for vitamin D deficiency. Our hypotheses are 1) that the urine calcium-to-creatinine ratio correlates with blood vitamin D levels in infants and toddlers at risk for vitamin D deficiency and 2) that this test can be used to screen for vitamin D deficiency. Potential Impact. A validated screening tool would allow for the detection of vitamin D deficiency before the development of rickets, decreasing the morbidity and mortality of this common disease.
This research is being done to test the effectiveness of two treatments aimed at increasing language and social skills in children with autism spectrum disorder. If children show improvement in these treatments, we hope that the availability of public services for minority and low income families will be increased. Minority and low income families with children between 22 and 33 months of age with Autism Spectrum Disorders may join.
This study will compare the effectiveness of two parent-based programs for helping young children at risk of autism.
In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 in a previous study (whose objectives \& outcome measures are presented in a separate protocol posting with NCT number =00471081) will be evaluated. The safety and immune response of a booster dose of vaccine GSK134612 administered at 5 years post-primary vaccination will also be evaluated. In addition, the immune response to a dose of vaccine GSK134612 administered to age-matched controls not previously given a meningococcal vaccine will be evaluated. This protocol posting has been updated further to protocol amendment 2, dated 28 october 2010. The sections impacted are summary, study design, outcome measures, intervention, and eligibility criteria.
Safety immune response of Novartis MenACWY-CRM conjugate vaccine when given to healthy toddlers
The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9 and 12 months of age.
This is an unblinded, feasibility study of an adapted positive parenting intervention to be carried out in a small sample (n=12 dyads) of young children with FASD and their primary caregiver in King County, WA.
The purpose of this study is to evaluate the safety and immunogenicity of PCV21 versus 20vPCV ( 20-valent pneumococcal conjugate vaccine, Prevnar 20) for catch-up vaccination in infants (7 to 11 MoA-Months of age), toddlers (12 to 23 MoA), and children/adolescents (2 to 5 YoA and 6 to 17 YoA-years of age).
The purpose of this study is to treat toddler obesity by improving the toddler nutritional environment. Parents will participate in a free internet nutrition program and may also take obesity medication. These measures may improve the parental nutritional environment and in turn, improve the toddler nutritional environment as well.
Background and Significance: Bifidobacterium longum subspecies infantis (B. infantis) and other infant associated Bifidobacterium (such as Bifidobacterium longum subspecies longum and Bifidobacterium breve) are known to be important bacteria in the infant gut microbiome. A lack of Bifidobacterium in the infant gut may lead to disordered development of the infant microbiome and immune system, which can contribute to the development of gastrointestinal issues, pathogenic infections, and immune-related conditions including allergic disease and autoimmune disorders. The investigators hypothesize that establishing Bifidobacterium in the infant gut through delivery of a synbiotic, containing bifidobacterium and human milk oligosaccharides (HMOs; Bifidobacterium's primary nutrient source) may modulate the microbiome and correct this disruption. Research Question: Does synbiotic supplementation on infants and toddlers of various ages alter the gut microbiome as measured by GI-tolerance, fecal microbiome composition, and fecal metabolic profile? Objectives: * Demonstrate shifts in microbiome composition and metabolism * Demonstrate tolerance by observing neutral or positive shifts in GI related behaviors Study Design Overview: Participants Infants aged 2-24 months will be enrolled to evaluate the ability of a synbiotic (human milk oligosaccharide + a Bifidobacterium blend (B. infantis, B. longum, and B. breve)) to modulate the gut microbiome. Infants will be randomly split into two cohorts, one that receives synbiotic supplementation and one that receives a placebo control (lactose). Initially, only ages 12-24 months will be enrolled (first 25 participants), and a safety review will be performed prior to enrolling younger infants. Cohorts * Cohort 1 (supplementation) participants will be aged 2 months to 24 months. They will receive synbiotic supplementation for 1 month. * Cohort 2 (no supplementation) participants will be aged 2 months to 24 months. Will receive placebo (lactose) over the course of 1 month. Design Caretakers will be recruited and screened using an online questionnaire to determine eligibility and cohort assignment. They will give consent using an online one-party consent form (Appendix 1). Participants will be distributed randomly between cohorts 1 and 2. Participants will be shipped the synbiotic or placebo (lactose) and a set of stool sampling kits. Calls with the participant will take place throughout the study as necessary to explain participant responsibilities and ensure compliance. Two sample types will be collected during the study, a full fecal sample and a DNA/RNA tube only. The full fecal sample will be collected at the beginning and end of supplementation and the DNA/RNA tube only will be collected at all other time points. Samples will be collected at supplementation start, one week after supplementation, four weeks after supplementation start (coinciding with the end of supplementation) and 6 weeks after supplementation start (coinciding with a 2 week washout period). Journals and questionnaires will be used for the duration of supplementation as well as 2 weeks before and after to assess the impact of supplementation. Laboratory Assessments: Stool samples will be obtained for each subject. The first sample will be taken before supplementation start. Additional samples will be collected: after 1 week of supplementation, after 1 month of supplementation, and after a 2 week period of no supplementation (a washout period). All samples will be collected at home and shipped back to Persephone Biosciences for processing. The initial sample and the sample after 4 weeks of supplementation will be full samples for metagenomic, metabolomic, and proteomic analysis. The 1 week after supplementation and 2 week post supplementation samples will be DNA/RNA tube samples for metagenomics only. Microbial whole genome sequencing, metabolite analysis, and immune profiling will be performed on stool from complete stool kits. Microbial whole genome sequencing alone will be performed on the DNA/RNA tube kits. Data Collection: Demographic data, general health information, diet and lifestyle information will be collected from the subjects (all self-reported). Journals and questionnaires will be used to evaluate the impact of the synbiotic.
This study will examine the relation between behavioral emotion regulation (ER) strategies at toddler age 3 to cognitive ER strategies in early adolescence as part of an ongoing longitudinal study of children\'s typical development. Aim 1 is to test whether self-soothing/caregiver-focused and distraction behavioral ER strategies at child age 3 predict avoidant and engaging cognitive ER strategies, respectively, at a follow-up assessment to be completed when children are 10-14 years old. In a completed wave of data collection, children\'s ER behaviors were elicited in laboratory tasks characterized by threat (novelty and uncertainty) at age 3. Avoidant and engaged cognitive ER strategies will be assessed by youth self-report, parent-report, and interviews with youth after they engage in new laboratory tasks characterized by mild threat. Hypothesis 1a: Self-soothing/caregiver-focused toddler behavioral ER strategies will predict avoidant cognitive strategies in early adolescence. Hypothesis 1b: The toddler behavioral ER strategy of distraction will predict engaged cognitive ER strategies in early adolescence. To provide additional developmental information, Aim 2 is to test whether child age at the follow up assessment (ranging 10-14 years) moderates the relation between behavioral ER strategies at age 3 and cognitive emotion regulatory strategies in early adolescence. Hypothesis 2: Because older children will have undergone more development underlying cognitive ER strategies, relations specified in Hypotheses 1a and 1b will strengthen across older ages. Finally, the Exploratory Aim is to test theoretically-supported individual (i.e., inhibited/fearful temperament) and environmental (i.e., family emotional environment) variables as potential mediators or moderators of the relation between behavioral ER strategies at age 3 and cognitive ER strategies in early adolescence. The investigators expect inhibited/fearful temperament to be involved in the link between behavioral ER strategies and avoidant cognitive ER strategies. The investigators expect the emotional family environment to be involved in linking behavioral ER strategies to both avoidant and engaged ER strategies.
The study will assess if toddlers show differences in stranger wariness according to race, temperament, social network diversity, and neighborhood diversity.
This study is a Phase III, randomized, single-blind, placebo-controlled, multi-center study to be conducted in healthy infants and toddlers which will be enrolled at approximately 6 months of age (Cohort 1) and approximately 12 months of age (Cohort 2). The primary objective of the study will be to assess non-inferiority of the RSV infant and toddler (RSVt) vaccine antibody response when administered concomitantly with routine pediatric vaccines at 6 months of age (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine \[Vaxelis® or Pentacel® and Recombivax HB®\] Prevnar 20®, and RotaTeq®), and 12 months of age (M-M-R II, VARIVAX, and Prevnar 20 or per local country recommendations) compared to when administered non-concomitantly.
Children with clefts exhibit difficulty with language and literacy compared to children without clefts. However, little is known about interventions to address these difficulties in the cleft population. This study will test the efficacy of a parent-focused dialogic book-sharing intervention for toddlers with isolated cleft palate. The study will use a randomized controlled trial (RCT) design and Intention to Treat (ITT) analyses. Child outcomes include expressive and receptive language. Parent outcomes of interest include the frequency and quality of shared reading interactions. To assess mechanisms of action, the study will test whether changes in child outcomes are mediated by changes in parents' behavior. Analyses will also explore heterogeneity in outcomes to determine whether the intervention is more effective in certain clinical or demographic sub-groups.
This study is a phase III, randomized, observer-blind, placebo-controlled, multinational, multi-center study to be conducted in approximately 6300 children 6 months to \< 22 months of age. The purpose of the study is to evaluate the efficacy, immunogenicity, and safety of Respiratory Syncytial Virus Toddler (RSVt) vaccine administered by intranasal route compared to placebo. Eligible participants will be randomized in a 1:1 ratio to receive 2 intranasal administrations of either the RSVt vaccine or placebo. Study duration will be 24 months for each participant. The safety follow-up will start after the first vaccination and up to the end of the study.
The study is a multi-center, multi-national, prospective surveillance study in which the study participants will not receive a study vaccine but will provide a baseline blood sample and be followed for acute respiratory disease during 6 months. The 6-month follow-up will occur for the most part during the Respiratory Syncytial Virus(RSV) season (based on enrollment timing and as per feasibility). A maximum of 1000 children from 6 to \< 22 months of age are planned to be enrolled in 5 to 10 countries, 1 to 2 sites per country, targeting approximately 100 participants per country. The purpose of the study is to assess the seroprevalence and incidence of RSV disease during the study period in the targeted countries and sites for a Phase III vaccine study.
The primary goal of this study is to examine rhythm sensitivity as a predictor of response to naturalistic developmental behavioral intervention (NDBIs) in autistic toddlers. Toddlers receive either Reciprocal Imitation Training (RIT), an evidence-based NDBI that supports children's imitation and social communication skills, or a music-enhanced version of RIT. Throughout their participation in the intervention, toddlers will complete study procedures of viewing naturalistic videos of infant-directed singing and other social scenes while eye gaze data is collected.
The goal of this study is monitor anesthetic depth of children undergoing propofol anesthesia using electroencephalography (EEG). The main questions it aims to answer are: 1. EEG spectral edge frequency (SEF95) readings where 50% of patients do not respond to three stimuli. 2. The propofol blood concentration that corresponds to each of the three EEG SEF95 readings Participants will undergo EEG monitoring, stimuli (placement of oral pacifier, electrical stimulation, and laryngoscopy), and blood collection.
The primary purpose of the study is to assess the shedding, transmission, and genetic stability of the live-attenuated RSVt vaccine after each intranasal vaccination (56 days apart) in infants and toddlers 6 to \< 24 months of age.
The goal of this collaborative R01 is to demonstrate the therapeutic value and community-wide implementability of an early intervention (EI) platform for toddlers with autism spectrum disorder (ASD) that is completely virtual, from recruitment through intervention. This platform-Early Social Interaction Mobile Coaching (ESI-MC) deploys individual telehealth sessions with coaching and feedback to help families embed intervention in everyday activities. Specifically, the investigators will conduct an effectiveness trial of ESI-MC to address the important question of whether starting evidence-based intervention earlier leads to better outcomes than starting later. The investigators will address this question by using a modified stepped wedge design and blended implementation research to analyze data obtained with ESI-MC start at 18, 24, or 30 months. The investigators will diagnostically ascertain 240 children from a pool of 360 18-month-olds with early signs of autism, 30 in each of 8 US regions (Central and SW Florida; Atlanta, GA; suburbs of Philadelphia, PA; New York City, NY; Cincinnati, OH; Chicago, IL; Seattle, WA; and Los Angeles, CA). Research participants will be recruited using a new virtual platform-My Baby Navigator-linking a new surveillance and screening tool, an app to upload video-recorded home observations and telehealth intervention sessions, and a package of educational resources. The 240 children will be randomly assigned to one of three ESI-MC timing groups. ESI-MC will be delivered by community-based early intervention providers (EIPs) currently working within the the early intervention system in the recruitment regions. The investigators will measure child active engagement and social communication change every 6 months as the primary outcome variables. Outcome measures of developmental level, autism symptoms, and adaptive behavior will be examined to measure differential treatment effects. Maximizing the use of mobile technology, ESI-MC offers the prospect of a community-viable, scalable and sustainable treatment to improve EI services for toddlers with ASD, particularly among minority and low-resource communities.
Improving social communication outcomes for toddler siblings of children with autism, who are at high risk for multiple language and communication deficits beyond autism, has important public health implications. The proposed study is a pilot sequential multiple random assignment trial of 44 high-risk siblings that examines the feasibility, acceptability, and preliminary effects of an adaptive intervention for social communication. Evaluating effective parent-mediated communication support strategies for toddlers at high-risk supports NIDCD's mission of behavioral research focused on disordered language development and the prevention of health impairments such as communication disorders.