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Developmental Delay clinical trials

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NCT ID: NCT02000284 Active, not recruiting - Clinical trials for Autism Spectrum Disorder

Mitochondrial Dysfunction in Autism Spectrum Disorder

Mito
Start date: October 16, 2012
Phase:
Study type: Observational

Researchers at Arkansas Children's Hospital Research Institute are conducting a study about mitochondrial function in children. The study involves up to 5 visits to Arkansas Children's Hospital with fasting blood draws, behavioral assessments, and/or questionnaires. This study is not currently recruiting, but continues to follow those who were enrolled. There is no cost for visits or study-related exams. For further information, please contact the program manager, Leanna Delhey, at ldelhey@uams.edu or 501-364-4519

NCT ID: NCT01975506 Completed - Developmental Delay Clinical Trials

Occupational Therapy in the Context of Head Start

Start date: November 2012
Phase: N/A
Study type: Observational

The purpose of this study is to identify the role of occupational therapy within Head Start programs. Representatives within Head Start will be asked to participate in a nationwide internet based survey identifying the amount and type of services provided within this area. The Model of Human Occupation (MOHO) will also be included in the study by identifying current use of the model and how it can be utilized in the future. In order to complete this study to the fullest extent, we must begin by defining the Model of Human Occupation as well as understanding the mission of the National Head Start Association. The vision of MOHO is to support practice that is focused on occupation, client centered, holistic, evidence-based, and complementary to other occupational therapy models. The mission of the National Head Start Association is to coalesce, inspire and support the Head Start field as a leader in early childhood development and education. This has lead researchers to perform the following study: An examination of occupational therapy in the context of Head Start.

NCT ID: NCT01660958 Completed - Developmental Delay Clinical Trials

Project Grow Smart: Intervention Trial of Multiple Micronutrients and Early Learning Among Infants in India

GrowSmart
Start date: August 2012
Phase: N/A
Study type: Interventional

Project Grow Smart evaluates the impact fortification with multiple micronutrient powders (MNP) vs. placebo (one vitamin) on child development (primary outcome) and on micronutrient status, growth, and morbidity (secondary outcomes) among young children in rural India (Nalgonda district of Telegana). There is an infant phase and a preschool phase; investigators, study team members, and participants are unaware of whether the fortification is MNP vs. placebo. The infant phase (enrollment age: 6-14 months) is a 4-cell factorial randomized trial (MNP vs. placebo and early learning vs. routine care), conducted through home visits. Sachets (MNP/placebo) are distributed to be mixed with food. The hypotheses in the infant phase are: 1) MNP leads to better development, growth, and micronutrient status; 2) Early learning leads to better development; 3) Integrated MNP plus early learning leads to better development through both additive and synergistic processes. Developmental evaluations and anthropometric measurements are conducted at baseline, mid-line (6 months), and end-line (12 months). Blood draws for micronutrient status are performed at baseline and endline. Morbidity measures are collected monthly using a morbidity form, modeled after the Demographic and Health Survey. The preschool phase (enrollment age: 30-48 months) is conducted in Anganwadi Centers (AWC) (preschools). AWC are classified as high or low stimulation, based on an objective observational rating system of the physical environment of the preschools and teacher-child interactions. Preschools are categorized into high/low-quality based on median split, followed by random assignment of MNP/placebo nested within high/low-quality preschools. The hypotheses in the preschool phase are: 1)MNP leads to better development, growth, and micronutrient status; 2) the effect of the MNP on preschoolers' development varies by the quality of the AWC, with stronger effects among preschoolers in high-quality AWCs. The intervention has been modified to coincide with the academic term (September-May). Evaluations are conducted at baseline (September) and end-line (prior to May), with an 8-month intervention period.

NCT ID: NCT01581489 Completed - Iron Deficiency Clinical Trials

Early Versus Delayed Cord Clamping at Term: Neurodevelopmental Outcomes in Swedish Infants at 4 Years of Age

Start date: April 2012
Phase:
Study type: Observational

Delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by increasing the infant's iron endowment at birth. Compared to early clamping, a delay in clamping in clamping of around 2-3 min provides an additional 25-40 mL of blood per kg of bodyweight to the newborn infant. The results of previous intervention studies on delayed clamping are mixed, and few have followed the infants beyond the perinatal period. All longer follow up studies have been performed in low income countries except for the investigators earlier study, showing less iron deficiency and improved iron stores after delayed cord clamping at 4 months of age. The main objective of the current study is to assess whether the time of cord clamping affects neurodevelopment at 4 years of age in a large sample of full-term, Swedish infants. The investigators hypothesis is that as delayed cord clamping improves iron stores at 4 months, this could affect the child's development positively.

NCT ID: NCT01517048 Completed - Obesity Clinical Trials

Brain-Derived Neurotrophic Factor in Obesity and Brain Function

Start date: January 9, 2012
Phase:
Study type: Observational

Background: - Prader-Willi syndrome (PWS) and MC4R genetic mutations are two conditions that can cause problems with appetite regulation. People with PWS often have behavior and thinking problems. People with MC4R mutations may have problems with attention. These problems may be related to Brain-Derived Neurotrophic Factor (BDNF), a protein that is important for brain development. Researchers want to study people with PWS and MC4R mutations to see how BDNF is involved in these conditions. Specifically, body weight and brain function will be studied, and compared with healthy volunteers. Objectives: - To study how BDNF affects body weight and brain function in people with PWS and MC4R mutations. Eligibility: - Individuals of any age who have Prader-Willi syndrome or MC4R genetic mutations. - Healthy volunteers of any age to act as control participants. Design: - Participants will be screened with a medical history and physical exam. Height, weight, and waist/hip circumferences will be measured. Blood samples will be taken for genetic and other tests. - Participants will fill out questionnaires about eating habits, pain perception, and sleep behavior. - Participants will keep a 3-day food diary to record all food and drinks eaten. - Tests and questionnaires will be given to study thinking, speech, movement, behavior, and mood. Some tests will be done on a computer; other tests will be on paper. Tests may also involve performing tasks with blocks and other objects. - Participants may have other tests as directed. These will include hot and cold sensitivity tests, imaging studies like x-rays, and measurements of body fat and water content. - Treatment will not be provided as part of this study.

NCT ID: NCT01452061 Completed - Clinical trials for Autism Spectrum Disorder

Evaluating the Validity of a Genetic Risk Assessment Tool in Identifying Autism Spectrum Disorder

Start date: January 2012
Phase: N/A
Study type: Observational

There are three purposes to this study. The first purpose is to evaluate the value of a genetic test in determining risk for autism spectrum disorder. Processing for genetic samples will be completed at the Cleveland Clinic using research equipment provided by IntegraGen. The second purpose is to identify genetic changes that may be associated with autism spectrum disorder or attention deficit/hyperactivity disorder. The third purpose is to examine whether genetic differences and changes may predict which individuals benefit from medicine used to treat attention problems or other psychiatric difficulties. Between 600-800 people are expected to participate in this study - approximately 300 individuals with an autism spectrum disorder, 75 individuals with attention deficit/hyperactivity disorder or another developmental or psychiatric disorder, 100 healthy siblings, and 125 unrelated individuals without a developmental or psychiatric disorder. Study procedures will vary based upon the specific group participants are suspected to fall into (autism, attention deficit/hyperactivity disorder, psychiatric concerns/developmental delay, healthy sibling, or unrelated healthy control). - All individuals will be asked to participate in a cheek swab (gently swabbing the inside of your cheek) to obtain cells used for genetic testing. Genetic material will be stored with identifiers such as numbers, letters or codes. - Parents or caregivers will be asked to complete questionnaires that examine medical and family history as well as current symptoms and quality of life for the participant. - Participants may undergo speech and language testing. This involves answering questions, looking at pictures or identifying items. - Information recorded in participant medical records will be reviewed and collected for this study.

NCT ID: NCT01426698 Completed - Developmental Delay Clinical Trials

18 Month Follow Up of Preterm Infants Enrolled in the Cord Clamping Study

18mo
Start date: August 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine differences in the long-term effects of immediate versus delayed cord clamping at birth on developmental outcomes of our study infants at 18-22 months corrected age.

NCT ID: NCT01351077 Completed - Developmental Delay Clinical Trials

CHICA Developmental Screening Study

Start date: May 2011
Phase: N/A
Study type: Interventional

Between 12 and 16% of children in the United States have a developmental disability. Research has demonstrated that early intervention programs are not only essential for improved outcomes in these children, but also cost-effective. As a result, there has been a push within the pediatric medical community to identify children with developmental delays or disabilities as early as possible. Currently, most pediatric primary care providers do not use standardized methods for developmental surveillance and screening. Instead they rely on intuition and clinical judgment which has been shown to have limitations when compared with standardized screening methods. Researchers and physician organizations such as the AAP have called on pediatric primary care providers to institute a standardized approach for the identification of developmental delays that includes both developmental surveillance and screening. In fact, the AAP recently published an algorithm for developmental surveillance and screening within a primary care setting. Physicians, however, cite several barriers to the implementation of these recommendations within their practices, including lack of time, lack of office staff, inadequate reimbursement, and language barriers. The investigators have developed a novel computer decision support system (CDSS) for implementing clinical guidelines and algorithms within pediatric practices called CHICA. The investigators believe that this CDSS has the potential to address the barriers cited in previous studies as obstacles specific to the implementation of developmental surveillance and screening within primary care practices. CDSS will allow for developmental surveillance and screening to fit within the workflow of a busy pediatric practice without requiring an additional investment of time on the part of the physician and without requiring additional office staff. The aims of this study are to (1) Expand and modify an existing computer-based decision support system (CHICA) to include the 2006 AAP developmental surveillance and screening algorithm; (2) Evaluate the effect of the CHICA system on the developmental surveillance and screening practices of four pediatric clinics; (3) Evaluate the effect of the CHICA system on referrals for developmental and medical evaluations as well as early developmental intervention/early childhood services for those children identified as having concerning developmental screening results; and (4) Develop a cohort of children with identified developmental disabilities that can be followed over time in order to look at the end results/effects of developmental screening

NCT ID: NCT01253083 Completed - Cerebral Palsy Clinical Trials

Mobility Training to Improve Motor Behavior in Toddlers With or at Risk for Cerebral Palsy: A Pilot Study

Start date: November 15, 2010
Phase: Phase 1
Study type: Interventional

Background: - People who have cerebral palsy often have difficulty walking and moving their legs. Cerebral palsy is sometimes not identified until a child is almost 2 years of age, which means that early motor skill development can be affected and can have repercussions for later development. Studies in adults with neurological injuries (e.g., stroke, spinal cord injury) have shown that it is important to start intensive therapy soon after the injury, and it may be true that starting intensive therapy at a young age will be helpful for children with cerebral palsy. Researchers are interested in testing the effectiveness of a special body weight support system for mobility training in young children who have or are at risk for cerebral palsy. Objectives: - To study the effectiveness of a mobility training program on the motor skills of young children who have or are at risk for cerebral palsy. Eligibility: - Children between 12 and 36 months of age who have delayed motor skills and either have been diagnosed with cerebral palsy or show evidence of spasticity or brain damage. Design: - This study involves two 6-week study phases: a baseline phase and a mobility training program. - Participants will be screened with a physical examination and medical history. - During the baseline phase, participants will have mobility testing sessions once every 2 weeks. These tests will measure motor development and ability, including ease and speed of walking. - Participants' parents/guardians will receive a mobility sensor for the child to wear at home for at least 6 hours (awake time) to measure activity and mobility levels outside of the testing sessions. - After 6 weeks of baseline testing, participants will have 6 weeks of mobility training for 30 minutes 3 days per week. Training will involve motor tasks with weight support, conducted by a pediatric physical therapist. Activities may include walking, climbing inclines or steps, or squatting to reach toys. All sessions will be videotaped. - To evaluate the effects of the therapy program, participants will have testing sessions every 2 weeks. - Parents/guardians will also complete questionnaires to provide feedback on the effectiveness of the therapy program.

NCT ID: NCT01207570 Completed - Cerebral Palsy Clinical Trials

Endermotherapy for Children With Developmental Disabilities

Start date: February 2010
Phase: Phase 2
Study type: Interventional

Children with developmental disabilities often sustain decreased range of motion in their extremities. The decrease in flexibility may be due to neuromuscular disorders such as spasticity or dystonia. Other causes may be imbalance in muscle strength surrounding a joint, leading to inappropriate habitual posture. Over time, muscle contracture may result for those muscle groups that are placed in a shortened position for an extended period of time. The most common site of muscle contractures among these children are gastrocnemius/soleus (lower limbs), and latissimus dorsi muscles (upper limbs). Muscle contractures can lead to further decline in functional abilities. Therefore, it is important to identify effective intervention strategies to enhance or maintain muscle flexibility in children with developmental dysfunctions. Commercially available endermotherapy device has been used to soften scar tissue following burn injuries. The mechanical stimulation applied may also have beneficial effects on relaxing the muscle tissue. The overall aim of the proposed study is to determine whether endermotherapy treatment has immediate effect in improving joint range of motion among children with developmental disabilities. The research hypothesis is that children in the endermotherapy group will have significantly more gain in ankle passive range of motion than those in the control group.