Clinical Research Directory

Electrophysiologic Sleep Phenotyping and Sleep-Dependent Neuro-maturation in Clinical and Healthy Pediatric Populations

Background: During the first few decades of life, the brain changes dramatically in shape and function. Sleep lets researchers measure these changes. Researchers want to create a database of sleep and neurodevelopmental data in a group of infants and children to learn more. Objective: To address a knowledge and data gap in the field of sleep and neurodevelopment in infants and children. Eligibility: Children ages 6 months to 76 months who may or may not be at risk for neurodevelopmental and neuropsychiatric disorders. Also, children ages 6 months to 8 years who have a referral for a sleep study. Design: Participants will have neurodevelopmental testing. They will have a medical, psychiatric, and family history. They will have a physical and neurological exam. They will be interviewed and complete surveys. They will give a cheek swab and/or blood sample. Some participants will have 1 study visit that lasts 2 days. Other participants will have up to 4 study visits. Each visit will last 2 days. Visits occur every 8 months to 1 year, for a total participation time of 2 years. Participants will have a 20-minute daytime electroencephalogram (EEG), if possible. This EEG session will be used to calibrate the machine for the overnight study. Participants will take part in an inpatient overnight sleep study. Electrodes will be placed on the participants. For young children, parents will help place the EEG leads. Other sensors may also be placed. A gauze cap will be placed on participants head to protect the leads and keep the participants from moving them. 'Lights out' will occur as close to participants bedtime as possible.

To Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth and Development, Incidence of Allergy and Immune Function in Infants

This study is a 180-day randomized, double-blind, placebo-controlled trial involving healthy infants and young children under 3 years of age with elevated allergy risk. Participants are randomized to receive either Bifidobacterium animalis subsp. lactis XLTG11 probiotic or placebo daily. The primary clinical outcomes assessed are incidence and day-level burden of allergic, respiratory, and gastrointestinal symptoms. To investigate potential mechanisms, fecal samples were collected pre- and post-intervention for shotgun metagenomic sequencing to analyze changes in gut microbiota composition, functional pathways (KEGG, COG, GO), and mucosal immune markers (β-defensin 2, LL-37, calprotectin, sIgA) associated with clinical improvements.

Outdoor Science Education and Child Well-being in Primary Schools: Protocol for a Cluster Randomized Controlled Trial on Learning, Connection to Nature, Eco-anxiety, and Stress

The goal of this randomized controlled trial is to learn if an outdoor science education intervention can improve primary school students' learning and well-being when compared to an indoor classroom-based science education intervention. The main questions it aims to answer are: * Will students who engage in outdoor science learning produce higher-quality observations of living organisms than students who receive instruction exclusively in an indoor, classroom-based context, when both groups are invited to make observations in an unfamiliar natural environment? * Does an outdoor education intervention embedded within the science curriculum contribute to children's connection to nature, eco-anxiety and stress? Participants will: * Receive a science education intervention 2h/week for a total of 5 weeks, either indoors or outdoors * Answer questionnaires before and after the intervention * Participate in a field day-trip after the intervention where they will be asked to observe living organisms.

Clinical Performance and Antibacterial Effect of Alkasite Bioactive Material in Restoring Pulpotomized Primary Molars

The study aims to evaluate the clinical performance of Cention-Forte (CF) material in the restoration of pulpotomized second primary molars compared to conventional stainless steel crowns (SSC), and also to assess the restorations' antibacterial effect on salivary cariogenic bacterial count.

Physical Activity Intervention

Obesity is a problem that affects almost every region of the world. In Chile, data indicate that the prevalence of obesity in preschool children aged 4 to 6 years is 58%, which increases as they reach adolescence and adulthood. The role played by physical inactivity in the development of obesity is so relevant that it has been established that in children it is one of the factors that most contributes to the development of obesity. Among factors that influence adherence to healthy lifestyles are motor competence (CM) and physical condition (CF); Both CM and CF are factors that generate an underlying mechanism that decreases the risk of obesity and promotes health. Health-related quality of life \[HRQoL\] refers to an individual's subjective perception of the impact of health status on their physical, psychological, and social functioning. Overweight and obesity influence HRQoL. Physical activity interventions applied from an early age have proven to be a useful means of preventing childhood obesity, being more effective when implemented in the school environment and is key to achieving long-term results. The ecological model of physical activity favors modifying active lifestyle behaviors including intrapersonal, interpersonal, organizational, community, physical-environmental and political factors. Using the ecological model, physical activity interventions have managed to increase the levels of physical activity since the child and the entire environment that surrounds him or her are involved, that is, they have included the biological and behavioral, along with the motivational, school, in addition to taking into account environmental, cultural and socioeconomic aspects. The general objective of the project is to determine the effect of a physical activity intervention based on the ecological model, in the improvement of obesity parameters and quality of life in preschoolers from 4 to 6 years old. The study is experimental through a cluster-randomized clinical trial; of pre and postest. The methodological approach is mixed. Physical Condition will be measured through the PREFIT battery with the following components: body composition (weight, waist circumference; hip circumference, BMI); Musculoskeletal capacity (upper body strength, lower body strength; speed/agility); Cardiorespiratory capacity. Motor competence will be measured through the Children's Movement Assessment Battery (MABC-2) with the following components: Manual dexterity; Marksmanship and catch; Balance. Health-related quality of life will be assessed through the KINDL-R questionnaire for parents, in the validated version in Spanish; Sedentary behaviour and physical activity ActiGraph wGT3X-BT accelerometers will be used. To determine the effect, statistical tests will be applied for intragroup analysis and intrasubject repeated measures, considering p \<.05 as significance. When statistically significant differences are found, the effect size will be calculated. In addition, the use of mixed regression models is contemplated where the models will be adjusted for baseline values and age. It is hypothesized that the physical activity intervention based on the ecological model will lead to a 3% decrease in body fat, improves anthropometric measurements, physical condition, improved competence and health-related quality of life.

Functional Training and Dynamic Play Exercise on Gross Motor Skills, Physical Fitness, and Balance in Healthy Children

This study aims to explore and compare two distinct approaches to physical activity: functional training and dynamic play exercises, focusing on their effects on children's gross motor skills, physical fitness and balance. A randomized clinical trial will be conducted. The study will be conducted at Primary school of Lahore in a total duration of 10 months. Sample size will be 38. There will be two groups. Non-probability convenient sampling techniques will be used. The sample having the following characteristics will be included; Age 7-10 years, Both genders, Cognition MMSE score \> 25, Class grades 2-5 , BMI between 5th - 85th percentiles, Able to stand and walk independently, PBBS score \> 40, TGMD-2 \> 13, TUDS \> 10 secs. The population having the following characteristics will be excluded from the study; Pes Planus \& Pes cavus, Scoliosis, Genu valgum, Genu varum, Juvenile Idiopathic Arthritis, Presence of Asthma, Acute orthopedic problem and any history of surgery past 6 months, visual, vestibular, or balance disorders. The tools that will be included in this study are: Pediatrics balance scale, Test for gross motor development (TGMD-2) and Time up and downstairs test (TUDS). SPSS version 27 will be used for data analyses.

Symptoms, Pulmonary Function, Muscle Strength, Exercise Capacity, and Frailty in Esophageal Atresia vs. Healthy Peers

Esophageal atresia is the most common congenital anomaly of the esophagus and is caused by abnormal development of the esophagus during intrauterine life. In children with esophageal atresia, structural abnormalities due to congenital anomalies and tracheoesophageal fistula, tracheomalacia, respiratory problems, recurrent respiratory tract infections, structural abnormalities, surgical interventions for repair and treatment, and decreased physical activity levels may negatively affect pulmonary function, effective coughing, muscle strength, exercise capacity, posture, motor function, and quality of life. This study aims to compare physical characteristics, body composition, pulmonary function and muscle strength, peak cough flow, posture assessment, peripheral muscle strength test, motor function, exercise capacity, physical activity level, fatigue, frailty and quality of life between children with esophageal atresia and their healthy peers.

Urdu Translation of Revised High-Level Mobility Assessment Tool (HiMAT) in Healthy Children

The ability to move with ease is labelled as mobility. Limitations in mobility are frequent, recovery of these skills is crucial for physical performance which gives children valuable social possibilities and has long-term advantages for their physical and mental health. The high-level mobility assessment tool (HiMAT) is a unidimensional performance to measure the degree of high-level mobility in traumatic brain injury patients. The revised HiMAT has been utilised recently in paediatric populations to assess clinical trial outcomes and measure high-level motor skills. Urdu translation of revised HiMAT will be executed by using forward backwards translation method. Two bilingual translators fluent in both Urdu and English languages will facilitate the researcher in the translation of the tool. This final translated version will be then tested for validity and reliability on all participants of the study. The psychometric properties of the tool will be assessed including reliability, internal consistency, and item discrimination.

Correlation of Gross Motor Movement, and Balance With Screen Time in Healthy Children

Gross motor function involves large muscle control for activities like walking, running, and sports, and is essential for balance and coordination. Excessive screen time may hinder gross motor development by reducing physical activity, affecting strength and coordination. Structured activities like free play and exercise are key to minimizing these effects. A cross-sectional study will be conducted over 10 months in public and private schools in Lahore. Children aged 7-10 will be included. Screen time will be assessed through demographic data, and gross motor skills evaluated using the TGMD-2. Exclusion criteria: PBS \< 20, TGMD-2 \< 30, recent orthopedic surgery, and MMSE \< 26. Data will be analyzed in SPSS v25 using descriptive statistics and correlation. This study explores the impact of screen time on children's physical development, particularly gross motor skills and balance

Nutrition and Cognitive Function in Preadolescents

This study is designed to evaluate cognitive function in preadolescents who have different body mass indexes.

Improvements in Daily Activity and Exercise in School Children: the ActChild Study

The goal of this clinical trial is to assess the health-related effects of an exercise intervention in children aged 5-8 years. Main research questions: * Does a municipality-driven exercise intervention improve physical activity levels in children? * Does a municipality-driven exercise intervention improve sleep parameters in children? * Does a municipality-driven exercise intervention improve eating behaviors in children? * Does a municipality-driven exercise intervention improve quality of life in children? Study Design: Participants will be assigned to either: * Intervention group: Attend 1-2 weekly sessions of 45-60 minutes of child-friendly exercise for 1 year. * Control group: Receive no intervention. Data Collection: Participants will: * Complete questionnaires at baseline, and at 1-year, 3-year, and 5-year follow-ups. * Wear accelerometers for 7 consecutive days at baseline, and at 1-year, 3-year, and 5-year follow-ups.

Plants Optimizing Development Study (PODS)

This study aims to conduct a randomized clinical trial to measure the effects of a 3-month daily mixed-soy food intervention vs. a control group receiving isocaloric foods on reproductive hormones, body composition, metabolic risk, fecal microbiota, and cognition among 8-11-year-old children. Additionally, this study will assess soy food intake immediately following participation in the clinical trial to determine changes in soy food acceptance in children.