Clinical trials

The goal of this observational study is to assess the impact of burn injury on cellular energetics in patients that have been admitted to the burn center at Arkansas Children's Hospital for burn care and require one or more procedures to clean, debride, and repair burn wounds will be eligible to participate in this study. During the study, we will collect the following information: * General background information such as date of birth, height, weight, and other basic information. * Medical information, such as: basic medical information, details of burn injury, vital signs on the day of surgery, medicines you take during your stay, and some clinical tests. * Blood, urine, and tissue during surgeries you have during your stay.

This study will compare bone mineral density in patients with severe hemophilia A receiving prophylaxis with emicizumab or efanesoctocog alfa. Participants will undergo assessments of bone mineral density, bone remodeling biomarkers, thrombin generation, plasmin generation, and joint health over a five-year period. The study aims to evaluate whether differences in prophylactic therapy are associated with differences in bone health outcomes.

This trial will determine whether adding ruxolitinib to a reduced intensity conditioning (RIC) regimen reduces the rate of graft failure following haploidentical (haplo) hematopoietic cell transplant (HCT) for children and young adults with sickle cell disease (SCD). This study will enroll and treat up to 24 participants. Recruitment is expected to last for about 2 years and participants will be followed for an additional 2 years post-HCT.

This clinical trial is examining the action and effects of several new drugs in the treatment of cystic fibrosis in children. In addition, several genetic factors are examined. The hope is that the ability to determine prior to treatment those individuals who will or will not respond to existing therapies will avoid needless risk of side effects and the high cost of a potentially ineffective treatment regimen. Understanding the way these drugs work in the body and the best way to study them is critical to expanding the use of these drugs to all patients with cystic fibrosis (CF).

The goal of this clinical trial is to learn how exercise and diet quality affect the health of adolescents with obesity. The main questions it aims to answer are: * Does exercise improve cardiometabolic health in adolescents with obesity? * Does enriching the diet with fruits and vegetables improve cardiometabolic health in adolescents with obesity? * Do exercise and a fruit and vegetable diet together provide greater health benefits than either one alone in adolescents with obesity? Researchers will compare four groups to see how exercise and diet impact health: * Standard Care Group: Receives the usual care for obesity. * Exercise Group: Receives weekly exercise coaching and participates in a 12-week exercise program. * Diet Group: Receives weekly dietary coaching and eats a diet enriched with fruits and vegetables for 12 weeks. * Combined Exercise and Diet Group: Receives both exercise and dietary programs, namely weekly exercise and dietary coaching, participation in a 12-week exercise program, and daily consumption of fruits and vegetables for 12 weeks. During the 12-week study, participants will attend three study visits to: * Provide blood, stool, and urine samples. * Answer questions about health, sleep, diet, and physical activity. * Undergo body scans to measure fat, lean, and bone mass. * Complete blood vessel function and liver fat content assessments. * Assess resting exergy expenditure. * Complete fitness tests. * Wear a fitness tracker to monitor physical activity and sleep patterns.

The goal of this clinical trial is to compare antifungal therapy duration in pediatric uncomplicated candidemia. The specific aims are: * Compare the desirability of outcome ranking in children with uncomplicated candidemia randomized to 7 additional days of antifungal therapy (standard-course) versus no additional antifungal therapy (short-course) after already receiving 7 days of echinocandin therapy. * Compare the 14-day desirability of outcome measure for subjects with a negative and those with a positive T2Candida® biomarker at day 7 of therapy within randomized groups. Participants meeting eligibility criteria will be approached and consented between day 5 and 7 of primary systemic antifungal therapy. On day 7 of primary systemic antifungal therapy, inclusion and exclusion criteria will again be reviewed for consented patients and those still eligible will be randomized 1:1 to the two study arms. Researchers will compare no additional antifungal therapy (short-course) versus 7 additional days of systemic antifungal therapy (standard-course) in pediatric patients with uncomplicated candidemia who have already received 7 days of primary systemic antifungal therapy to see if shorter durations are as effective as longer durations in treating uncomplicated candidemia.

The investigators want to learn how women's diets may impact breastfeeding outcomes. This study will help the investigators learn more about how diet and social factors like food access may impact mothers' health, breastfeeding, and their baby's health. Participants will attend a visit before birth, then 11 visits as their baby grows up. All visits will be remote using RedCap, phone or video call, text messaging or any other communication modalities of preference to the participant. The investigators will ask for personal information about participants' family, home, and finances, health literacy, medical history, current medications, pregnancy complications, mental health (depression, quality of life), confidence in breastfeeding, eating habits, and plan to feed their baby. After childbirth, the investigators will ask about participants' delivery and child's health, and request access to their child's medical records. Across all visits, the investigators will ask participants to measure their weight, height, blood pressure, activity and sleep, and child's length; the investigators will also ask them to ship urine, stool, and breast milk samples. The investigators will obtain a 24-hour feeding log for the child, as well as a log of what the mother ate and drank over 24 hours.

The goal of this observational study is to establish a clear vaccination protocol for pediatric patients (less than 21 years old) who have received treatment for B-cell Acute Lymphoblastic Leukemia/Lymphoma. The main study aims are: * Evaluate the persistence of protective immunity to routine childhood vaccinations in participants with B-ALL/Ly who have received blinatumomab. * To determine whether revaccination in participants with non-protective titers leads to restored humoral immunity. Researchers will compare results from participants who have received immunotherapy to those who have not received immunotherapy to see if immunotherapy versus other chemotherapeutic drugs adversely affect the protective immunity acquired through vaccination.

The long-term goal of this project is to learn whether a tailored physical activity program is practical, enjoyable, and helpful for families, and whether it has the potential to improve children's physical development and health. Before launching a large study, the research team completed several early phases to make sure the program met families' needs. First, a needs assessment was conducted with mothers to understand barriers to physical activity and what types of support would be most useful. Using this feedback, the program was refined and tested with three mother-child pairs over six weeks. Finally, there was an 18-week pilot randomized trial to examine feasibility and acceptability. Researchers are now conducting a larger randomized trial with up to 266 families. Half of the families are randomly assigned to receive the physical activity program, and half to a comparison group. The program combines fun, age-appropriate movement activities for children with practical support for parents. Sessions focus on building core movement skills such as jumping, balancing, running, and throwing, while also encouraging confidence, coordination, and enjoyment of being active. Activities can be adapted to each child's ability and home environment, making the program realistic for busy families. The program includes both in-person sessions and technology-based activities. In-person sessions provide hands-on support for learning new skills. Technology-based activities offer simple ideas families can use at home or during daily routines, such as hopping games, balance challenges, or quick movement breaks. Because parents in earlier phases wanted nutrition support, in-person sessions also includes a brief, child-friendly exposure to fruits and vegetables, along with simple recipes. A "Tasting Party" at the start of the program allows children to try different foods, and Veggie Meter scans at the beginning and end of the study help track changes in fruit and vegetable intake. Overall, this study will help determine whether a family-tailored physical activity program is a promising approach to improving physical activity, movement skills, and early health indicators in young children born to mothers with obesity.

Regular physical activity during pregnancy is safe and offers many health benefits for both mothers and their babies. Research over the past decade shows that exercise can help pregnant women gain a healthy amount of weight, lower their risk of gestational diabetes and high blood pressure, and reduce stress, anxiety, and symptoms of postpartum depression. Babies also benefit when their mothers are active, with lower risks of preterm birth, unhealthy birth size, and childhood obesity. Despite this strong evidence, very few exercise programs for pregnant women have been tested in real-world community settings, such as fitness centers, community health programs, or local organizations. Even fewer studies explain how these programs were delivered or what helped them succeed. Without this information, it is difficult for communities and health programs to offer exercise support that is both effective and practical for pregnant women. To address this gap, the research team adapted an evidence-based program called EXPECTING so it could be delivered by community organizations. Previous participants and community advisors helped to understand what changes were needed to make the program easier to offer while still keeping it safe and effective. The core parts of the program, including the type, amount, and intensity of aerobic and strength-building exercises, remained the same and are based on established pregnancy exercise guidelines. The adapted program, called COMMUNITY EXPECTING, includes both aerobic exercise and resistance training. The research team also developed specific supports to help community instructors deliver the program consistently and with confidence. All program components have already been tested in community settings and shown to be realistic, acceptable, and delivered as planned. This study will examine whether offering a structured exercise program in community settings helps pregnant women be more physically active than usual prenatal care alone. We will also assess whether the program can be delivered successfully and in a way that works for both participants and community providers. The results will help determine whether COMMUNITY EXPECTING is a practical approach for supporting healthy pregnancies in real-world settings.

There is reason to believe the current dietary reference intakes for dietary protein for children are too low. Furthermore, children with high levels of physical activity and fitness may require a higher requirement. To better understand the protein requirements in minimally and highly physically fit and active children 8-10 y old, investigators will use the indicator amino acid oxidation technique.

This is an 8 to14-week three-arm randomized controlled in children 8 to 12 years old. The main purpose of the study is to evaluate if stevia has benefits for weight control and metabolic function relative to caloric sweeteners, and whether it provides benefits in this regard similar to water.

This study is about preparing women with excessive weight to have better breastfeeding outcomes. By doing this study, the investigators hope to learn more about how hand expression of breast milk or colostrum during pregnancy can help prepare a mother to breastfeed after she has her baby and about how her diet affects the composition of her breast milk and her baby's growth and development.

The participants are being asked to take part in this clinical trial, a type of research study, because the participants are scheduled to receive or have recently received a hematopoietic cell transplant (HCT) or a solid organ transplant (SOT). Primary Objective To determine if pre-transplant screening for respiratory viral load predicts RVI within 1- year post-transplant among survivors. Secondary Objectives: * To develop and validate a classifier based on pre-transplant immunological profile predictive of developing an acute respiratory viral infection (aRVI), with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors. * To develop and validate a classifier based on Day +100 post-transplant immunological profiles predictive of developing an acute respiratory viral infection (aRVI),with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors .

The Expecting intervention as delivered in prior studies in a clinical setting is described in a previous approved IRB submission (Protocol 202954). The current project will seek to engage community stakeholders to translate Expecting to a community-delivered intervention and to test its acceptability, feasibility, and fidelity in a proof of principle study with 60 expecting mothers.

This single-arm pilot study will evaluate the feasibility and acceptability of a remotely delivered behavioral lifestyle intervention, adapted from the SmartMoms framework, to promote health gestational weight gain in pregnant women with overweight and obesity. Twelve to sixteen participants will receive weekly virtual motivational interview sessions with trained health coaches, review their daily weight data, step count, and continuous glucose monitoring data, and tailored guidance on physical activity and nutrition. Educational content will be delivered electronically, with peer support provided through a closed online group. A simulated (mock) control arm will be created post hoc from existing records for preliminary comparisons; all enrolled participants will receive the intervention.

The study aims to evaluate the accuracy of sleep trackers in children aged 2 to less than 18 years. Children undergoing polysomnography, the gold standard for assessing sleep quality and duration, at Arkansas Children's Hospital may be eligible to participate. Participants will be asked to wear sleep trackers on the day of their sleep test. The data collected from the sleep trackers will be compared with the polysomnography results to determine the devices' accuracy.

This research study is about how daily activities, behaviors, and fitness affect the health and function of blood cells and their mitochondria, which are the powerhouses of the cells. These small mitochondria inside the cells make energy, and are very important for the health of the body.

This study will help us learn more about how a mother's health during pregnancy may influence her child's growth and development later in life.

this study is aiming at learning more about primary ciliary dyskinesia (PCD) and tests that are used to diagnose this condition. One purpose of this study is to measure the level of nitric oxide in the nasal passages and examine how often the results correlate with other tests currently done to make the diagnosis.

This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive fungal infection (PIFI).

Intrauterine devices (IUDs) are a popular form of long-acting reversible contraception, with a high efficacy rate and few side effects. The insertion procedure for IUDs can be uncomfortable and painful. Sedation may be needed to improve patient comfort. The use of IUDs is increasing in the adolescent population, but perceived pain is a barrier to placement. Propofol is a commonly used agent for pediatric procedural sedation, but it has no analgesic properties. Ketorolac, a nonsteroidal anti-inflammatory drug, has been shown to reduce pain in adults and improve patient satisfaction when used prior to IUD placement.. The current study aims to determine if ketorolac, given in combination with propofol for IUD placement in adolescents, can improve comfort during placement and reduce pain following the procedure. Enrolled patients will receive ketorolac or placebo, in addition to propofol, for IUD placement. By comparing the outcomes of these two groups of patients, we can gain a better understanding of the optimal approach to sedation for IUD insertion in adolescents.