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Child, Only clinical trials

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NCT ID: NCT06426147 Not yet recruiting - Infections Clinical Trials

L-citrulline to Improve Adverse Outcomes in Admitted Children (EChiLiBRiST, Clinical Trial 2, Inpatients)

Start date: January 1, 2025
Phase: N/A
Study type: Interventional

In low and middle-income countries, children admitted to hospital are not similarly ill, and do not all have a comparable prognosis. In fact, understanding at first encounter their risk of developing adverse outcomes (including mortality) could allow a more focused management and the tailoring of specific interventions to decrease in hospital mortality, and post discharge adverse longer-term outcomes. This clinical trial, part of the EChiLiBRiST larger project ("Development and validation of a quantitative point-of-care test for the measurement of severity biomarkers to improve risk stratification of fever syndromes and enhance child survival") has the two-fold objective of: 1. Assessing whether a POINT-OF-CARE rapid triaging test (PoC RTT) based on the quantitative measurement at the bedside of the "prognostic" biomarker sTREM-1 (soluble-triggering receptor expressed on myeloid cells 1) can reliably identify those admitted children with a higher risk of adverse outcomes; and 2. Assessing whether the therapeutic intervention (the L-arginine precursor, L-Citrulline, key in the nitric oxide biosynthesis), administered orally for 28 days to those children aged 1-<60 months identified as "moderate-to-high risk" by the prognostic biomarker can improve outcomes as compared to those receiving an indistinguishable placebo. This second objective will be assessed in a prospective multi-country, multi-site, individually randomised, two-arm, placebo-controlled, double blind clinical trial involving ~888 children 1-<60m of age admitted to hospital and determined to be at high risk of adverse outcomes by their baseline sTREM-1 levels. The trial will compare the efficacy of a twice-daily dose of L-citrulline syrup vs placebo (200-300mg/kg/day depending on weight-band; for 28 days) in reducing adverse outcomes in children with severe disease. The trial will be running independently but in parallel in two high-mortality settings in Mozambique and in Ethiopia.

NCT ID: NCT06422338 Not yet recruiting - Child, Only Clinical Trials

A Rapid Triage Test to Improve Risk-stratification of Febrile Children (EChiLiBRiST, Clinical Trial 1, Outpatients)

Start date: December 1, 2024
Phase: N/A
Study type: Interventional

The overall aim of the study is to provide evidence that introducing soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) evaluation at triaging (first clinical assessment), in combination with IMCI-based guidelines (SoC), is a viable strategy to enhance rapid and accurate identification of febrile children at increased risk of life-threatening infections compared to IMCI-based strategies alone (SoC), and to demonstrate whether this results in enhanced decisions of admission/referral vs discharge, and enhanced overall health outcome of children with acute fever in sub-Saharan Africa.

NCT ID: NCT06364280 Not yet recruiting - Critical Illness Clinical Trials

Pediatric Prehospital Airway Resuscitation Trial

Pedi-PART
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

This study is a Phase 3, multi-center, Bayesian Adaptive Sequential Platform Trial testing the effectiveness of different prehospital airway management strategies in the care of critically ill children. Emergency Medical Services (EMS) agencies affiliated with the Pediatric Emergency Care Applied Research Network (PECARN) will participate in the trial. The study interventions are strategies of prehospital airway management: [BVM-only], [BVM followed by SGA] and [BVM followed by ETI]. The primary outcome is 30-day ICU-free survival. The trial will be organized and executed in two successive stages. In Stage I of the trial, EMS personnel will alternate between two strategies: [BVM-only] or [BVM followed by SGA]. The [winner of Stage I] will advance to Stage II based upon results of Bayesian interim analyses. In Stage II of the trial, EMS personnel will alternate between [BVM followed by ETI] vs. [Winner of Stage I].

NCT ID: NCT06350513 Not yet recruiting - Anxiety Clinical Trials

The Effect of Animated Movies and Storybooks on Fear and Anxiety Levels in Children With Type 1 Diabetes

Start date: March 25, 2024
Phase: N/A
Study type: Interventional

This study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes.

NCT ID: NCT06299267 Not yet recruiting - Child, Only Clinical Trials

The Effect of Dual Task on Manual Skill Performance in Children and Adolescents

Dual-task
Start date: October 15, 2024
Phase: N/A
Study type: Interventional

The aim of the study is to investigate the effect of dual-task conditions on manual dexterity performance in typically developing young people and children between the ages of 7-18. MATERIAL AND METHOD: - Demographic information, dominant extremity will be noted and the evaluation will begin by applying the Physical Activity Questionnaire for Children. - The evaluations will primarily evaluate the child's performance on a single cognitive task - The cognitive task will be the n-back task (counting down task) to be applied in accordance with the level of the child or adolescent. - Using the Visual Analogue Scale (VAS), participants will be asked to score the difficulty of the cognitive task as a number between 0 and 10. - the 9-Hole Test will be applied and the times will be recorded by asking to write a given paragraph. - Dual task evaluations will be administered by giving a simultaneous cognitive task while administering the -9-Hole Test and writing a paragraph. - In order to reveal the dual-task cost (DTC), dual-task performance will be subtracted from single-task performance and the difference will be calculated in seconds. As a result of this study, manual dexterity performance and cognitive performance in single-task conditions in typically developing children and adolescents will be revealed. Additionally, changes in this performance will be detected in dual-task situations.

NCT ID: NCT06291012 Not yet recruiting - Clinical trials for Community-acquired Pneumonia

Stopping Pneumonia Antibiotherapy Regimen Early

SPARE
Start date: September 1, 2024
Phase: Phase 4
Study type: Interventional

The hypothesis for this trial is that an antibiotic strategy for the management of non-severe community-acquired alveolar pneumonia in children aged 3 to 59 months, including amoxicillin 80-100 mg/kg/day for at least 3 days in case of rapid response and 5 days in case of delayed response, would not be inferior to current French recommendations (antibiotic therapy for 5 days in case of rapid response and 7 days in case of delayed response) in terms of treatment of failure rate at 7 days.

NCT ID: NCT06237894 Not yet recruiting - Postoperative Pain Clinical Trials

Multisensory Stimulation on Postoperative Pain, Physiological Parameters and Fear in Children

Start date: June 15, 2024
Phase: N/A
Study type: Interventional

It is known that non-pharmacological methods are effective in reducing pain in children and that they increase the effectiveness of drugs when used together with analgesics. Non-pharmacological methods are preferred because they are easy to apply and cheap, and they reduce the need for drug administration and thus the risk of side effects. Knowing the impact of pain and associated fear on children, developing appropriate pain control strategies is both a medical and ethical responsibility. Reviewing the literature, there is little scientific evidence that multisensory stimulation is an effective intervention in reducing pain and fear after surgery in children. When the studies on the effect of multisensory stimulation on pain and fear in childhood are examined, it is seen that the studies mostly aim to reduce pain and fear in the neonatal period or before surgery. It is thought that it is an important limitation that multisensory stimulation, which is an effective method for reducing pain and fear in childhood, does not examine its direct effects on postoperative pain, physiological parameters and fear after surgical procedures in children. In this context, the aim of the study is to examine the effect of multisensory stimulation on postoperative pain, physiological parameters and fear in children after the surgical procedure.

NCT ID: NCT05943587 Not yet recruiting - Chronic Pain Clinical Trials

The Development and Evaluation of Pain Neuroscience Education in Children

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

The International Association for the Study of Pain and The International Classification of Diseases (ICD) 11 define chronic pain as pain lasting more than 3 months, regardless of the cause. For children and adolescents, chronic pain is an extremely terrible and suffering problem. Periods of persistent pain negatively affect the child's participation in school and recreational activities, leading to academic problems and social exclusion. Moreover, children are at increased risk of experiencing chronic pain problems in adulthood. Because of these difficulties children with chronic pain should be treated as soon as possible. Pain Neuroscience Education (PNE) is an educational approach used in chronic pain rehabilitation. The purpose of PNE is to change individual's perception of pain. The most fundamental and crucial aspect of PNE is educating patients about the underlying causes of their pain. The primary purpose of the project is to conduct a modified Delphi survey to obtain and synthesize expert opinions on PNE materials. The second aim of this study is to investigate the effect of PNE on pain, quality of life and participation in children with chronic pain and compare it with the standard treatment program.

NCT ID: NCT05806983 Not yet recruiting - Cancer Clinical Trials

Evaluation of the Efficiency of the Technology-Based Psychosocial Empowerment Program Program

Start date: September 2023
Phase: N/A
Study type: Interventional

This research was planned to evaluate the effectiveness of the technology-based psychosocial empowerment program for home care for children aged 8-18 years with cancer and their parents as a parallel-group randomized controlled study design.The required institutional permission and ethics committee approval was received.The study group of the study consisted of 72 children and parents (intervention group [n=36], control group [n=36]). Data were collected using the descriptive features form, the General Self-Efficacy Scale-Pediatric Cancer Version, the State and Trait Anxiety Inventory for Children, the Pediatric Cancer Coping Scale, the General Self-Efficacy Scale for parents, the Problem-Solving Scale, and the Cope and Adaptatıon Process Scale. The data were stored in the SPSS 25 program.

NCT ID: NCT05566951 Not yet recruiting - Cancer Clinical Trials

Technology-Based Psychosocial Empowerment Program for Home Care of Children With Cancer and Their Parents

Start date: September 2023
Phase: N/A
Study type: Interventional

This research was planned to evaluate the effectiveness of the technology-based psychosocial empowerment program for home care for children aged 8-18 years with cancer and their parents as a parallel-group randomized controlled study design.The required institutional permission and ethics committee approval was received.The study group of the study consisted of 72 children and parents (intervention group [n=36], control group [n=36]). Data were collected using the descriptive features form, the General Self-Efficacy Scale-Pediatric Cancer Version, the State-Trait Anxiety Inventory for Children, the Pediatric Cancer Coping Scale, the General Self-Efficacy Scale for parents, the Problem Solving Inventory, and the Psychological Resilience Scale for Parents of Children with Cancer. The data were stored in the SPSS 25 program.