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Children clinical trials

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NCT ID: NCT06069492 Recruiting - Children Clinical Trials

Randomized Controlled Trial for Wheat Oral Immunotherapy

WOIT-RCT
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

IgE-mediated wheat allergy is a growing allergy problem in children, and affected children can predict with immediate-type allergic reactions to the extent of anaphylactic shock. Current diagnostic methods based on crude wheat extract are inaccurate and unreliable. Besides, these children are managed by a passive "wait-and-see" approach that reflect the natural history of wheat allergy. Nonetheless, a significant proportion of wheat-allergic children have persistent disease until school-age and adolescence. There is an unmet need for designing effective and safe immunotherapeutic strategy for wheat allergy. This study aims to investigate performance of allergy tests based on crude wheat and wheat allergens as measured using both quantitative and functional IgE-based assays for diagnosing IgE-mediated wheat allergy; and to compare efficacy and safety of different dosages of wheat oral immunotherapy (OIT) for treating these paediatric patients. For the initial part, this study will recruit children with immediate-onset adverse reactions after wheat ingestion for different allergy tests, with their wheat allergy ascertained by the gold-standard double-blind, placebo-controlled food challenge. The investigators will then recruit the wheat-allergic children into a randomized, double-blind, parallel-group clinical trial with low-dose and standard-dose wheat OIT for 12 months. The main outcomes include the diagnostic performance of different conventional and novel allergy tests for challenge-confirmed wheat allergy and the rates of desensitization and sustained unresponsiveness achieved by the two dosing regimens of wheat OIT.

NCT ID: NCT06034639 Recruiting - Children Clinical Trials

AI Based Multi-modal Parameter of Peripheral Blood Cells (MMPBC) Predicts Survival Risk in Critically Ill Children

Start date: March 1, 2023
Phase:
Study type: Observational

This study aims to investigate whether an AI prediction model based on blood cell multi-modal data can achieve early warning of survival risk in critically ill children through a large-scale multi-center cohort of critically ill children.

NCT ID: NCT05915026 Recruiting - Children Clinical Trials

A Study to Learn How Gadoquatrane Moves Into, Through, and Out of the Body and How Safe it is in Children (From Birth to <18 Years), Who Will Undergo a Contrast Enhanced MRI (Quanti Pediatric)

Start date: August 16, 2023
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to help children under the age of 18 with any known or suspected problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI). MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient's vein to perform a "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve their evaluation. The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd), which is needed for the increase in signal intensity and contrast in MRI. The gadolinium in these contrast agents is caged in a molecule (chelate complex). Researchers are developing new contrast agents with a lower amount of Gd needed per CE-MRI investigation. Gadoquatrane is one of these new contrast agents. It has been tested in several studies previously. The main purpose of this study is to learn how gadoquatrane moves into, through, and out of the body and how safe it is in children. The researchers will measure the amount of gadoquatrane in the blood at different time points after a single injection. The participants will undergo an MRI examination and receive gadoquatrane once at a dose of 0.04 mmol Gd/kg (corresponding to 0.1 mL/kg). It is injected into the participant's vein (also called an intravenous injection) during the MRI examination. Each participant will be in the study for between 8 and 38 days with up to 5 doctor visits, including the screening phase of up to 28 days with no more than 2 visits. Once a participant has received the injection of gadoquatrane, the remaining study duration is 7 (±1) days. At the start or during the study, the doctors and their study team will: - check the weight and height of the participant, - ask for information including age and medical history, - take participants' blood samples, - ask participants and/or their guardians questions about medicines they are taking, - check blood pressure, heart rate and body temperature, - check the area where the participants had the intravenous injection, - do pregnancy tests in girls of childbearing age, - review the MRI scans obtained in the study and decide on the diagnosis - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

NCT ID: NCT05781295 Recruiting - Children Clinical Trials

Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology

PEDIALOCK
Start date: January 19, 2024
Phase: N/A
Study type: Interventional

Interest of a Taurolidine lock at each catheter closure in the primary prevention of catheter-related endoluminal infection in paediatric oncology. Multicentric, controlled, randomized and double-blind label study.

NCT ID: NCT05767983 Recruiting - Healthy Clinical Trials

Effect of Dairy on Cognitive Performance in Children

Start date: October 18, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effects of dairy consumption on short-term cognitive performance, subjective mood and emotions, and glycemic response in healthy children aged 9 - 14 years. The investigators hypothesize that the consumption of dairy products as a mid-morning snack will improve mood and cognitive performance in children. Furthermore, the investigators hypothesize that all dairy products consumed as a mid-morning snack will imbue more benefits on mood and cognitive performance over 2-hours compared to fruit juice or snack skipping.

NCT ID: NCT05688371 Recruiting - Children Clinical Trials

Dexmedetomidine Plus Low Dose Morphine Versus Standard Dose of Morphine in PCA in Children .

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

The treatment of perioperative pain in children has been a topic of great interest to pediatricians, pediatric surgeons, and anesthesiologists for many years. Opioids are the most common analgesics used to manage acute postoperative pain in children and adults

NCT ID: NCT05529056 Recruiting - Myopia Clinical Trials

Study of Atropine Therapeutic Effect on Myopic Progression

STAMP
Start date: May 25, 2022
Phase: Phase 3
Study type: Interventional

This study is to evaluate the therapeutic effect and safety of LPTAT in children with myopia.

NCT ID: NCT05466097 Recruiting - Obesity Clinical Trials

Polygenic Risk Score to Predict Weight Loss Intervention in Children With Obesity

Start date: June 1, 2022
Phase:
Study type: Observational [Patient Registry]

Children with obesity are prone to suffering from metabolic diseases, which undoubtedly increases the burden of public health. Since obesity is a multiple gene disease, a comprehensive approach using polygenic risk scores (PRS), rather than individual genetic variant, may be a more appropriate method. The aim of the study was to establish a polygenic risk score model to assess differences to assess differences in weight loss treatment outcomes.

NCT ID: NCT05457283 Recruiting - Clinical trials for Chronic Kidney Disease

A Study to Learn More About How Safe the Study Treatment Finerenone is in Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age With Chronic Kidney Disease and Proteinuria

FIONA OLE
Start date: November 8, 2022
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine. The kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and/or proteinuria. These include "angiotensin-converting enzyme inhibitors" (ACEI) and "angiotensin receptor blockers" (ARB). Both ACEI and ARB can help improve kidney function by reducing the activity of the renin-angiotensin-aldosterone system (RAAS). The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can impair the ability of the kidneys to work properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system. The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB. So, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function. The main purpose of this study is to learn how safe the treatment is when used of finerenone in addition to an ACEI or ARB in long-term. To see how safe the treatment is, the study team will collect information on medical problems which are also known as "treatment emergent adverse events" (TEAEs). And they will also collect levels of an electrolyte called potassium in the blood by taking blood samples, and measure blood pressure during the study. The secondary purpose of this study is to learn how well long-term use of finerenone can reduce the amount of protein in the participants' urine and benefit kidney function when taken with standard of care. To see how the treatment works, the study team will collect participants' urine samples to assess urinary albumin-to-creatinine ratio (UACR) and urinary protein-to-creatinine ratio (UPCR), which are important assessments for calculating the level of protein in the urine. Researchers will also collect blood samples to analyze serum creatinine and calculate estimated glomerular filtration rate (eGFR). A significant decline in eGFR indicates worsening kidney function. The study will include participants who had previously participated in FIONA study (NCT05196035). The participants will be aged from 1 year up to 18 years. The participants will be in the study for approximately 19 months. They will take study treatment for up to 18 months and will be follow up for 1 month. During this period, at least 12 visits are planned for patients who newly start finerenone, and at least 8 visits for patients who already received finerenone. In the visit, the study team will: - have their blood pressure, heart rate, temperature, height and weight measured - have blood and urine samples taken - have physical examinations - have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart) - answer questions about their medication and whether they have any adverse events, or have their parents or guardian's answer - answer questions about how they are feeling, or have their parents or guardian's answer - answer question about how they like the study medication, or have their parents or guardian's answer The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The doctors will check the participants' health about 30 days after the participants take their last treatment.

NCT ID: NCT05337670 Recruiting - Children Clinical Trials

Probiotics Regulates Skin Care in Children

Start date: May 31, 2021
Phase: N/A
Study type: Interventional

Probiotics, a component that is generally referred to as a living microorganism or a microorganism present in a host. Most studies have shown that probiotics can regulate immune function in the body. Many studies have attempted to understand whether the use of probiotics can prevent allergic diseases or not.