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Child clinical trials

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NCT ID: NCT06320626 Recruiting - Child Clinical Trials

Pharmacokinetic-guided Dosing of Emicizumab

DosEmi
Start date: September 8, 2022
Phase: Phase 4
Study type: Interventional

The goal of this multicentre, prospective, open-label, cross-over clinical study is to determine whether individualized PK-guided dosing of emicizumab is non-inferior to conventional dosing of emicizumab in the prevention of bleeding in congenital haemophilia A patients.

NCT ID: NCT06315699 Recruiting - Child Clinical Trials

Clemastine Fumarate in the Treatment of Neurodevelopmental Delays in Williams Syndrome

Start date: March 20, 2024
Phase: Phase 3
Study type: Interventional

This study focuses on therapeutic targets for cognitive, motor, and social impairments in Williams syndrome by reversing brain myelin defects caused by GTF2I. The primary objective of the study was to test and evaluate the initial efficacy and safety of Clomastine fumarate in the treatment of Williams syndrome.

NCT ID: NCT06312410 Not yet recruiting - Child Clinical Trials

The VIA Family 2.0 - a Family Based Intervention for Families With Parental Mental Illness

Start date: March 18, 2024
Phase: N/A
Study type: Interventional

VIA Family 2.0 - a Family Based Intervention for families with parental mental illness Background: Children born to parents with mental illness have consistently been shown to have increased risks for a range of negative life outcomes including increased frequencies of mental disorders, somatic disorders, poorer cognitive functioning, social, emotional and behavioral problems and lower quality of life. Further these children are often overlooked by both society and mental health services, although they represent a potential for prevention and early intervention. A collaboration between researchers and clinicians from two regions, the Capital Region and the North Region Denmark has been established as the Research Center for Family Based Interventions. The research center is an umbrella for a series of research activities, all focusing on children and adolescents in families with parental mental illness. Method: A large randomized, controlled trial (RCT) for families with parental mental illness will be conducted in order to evaluate the effect of a two-year multidisciplinary, holistic team intervention (the VIA Family 2.0 team intervention) against treatment as usual (TAU). Inclusion criteria will be biological children 0-17 of parents with any mental disorder treated in the secondary sector at any time of their life and receiving treatment in primary or secondary sector within the previous three years. A total of 870 children or approx. 600 families will be included from two sites. Primary outcomes will be changes in child well being, parental stress, family functioning and quality of the home environment, . Time plan: The RCT will start including families from March 1st, 2024 to Dec 2025 (or later if needed). All families will be assessed at baseline and at end of treatment, i.e. after 24 months and after 36 months. Baseline data will inform the intervention team about each family's needs, problems, and motivation. TAU will be similar in the two regions, which means three family meetings and option for children to participate in peer groups. Challenges: final funding is being applied for. Recruitment of families can be challenging but we have decades of experience in conducting research in the field. Since both the target group, their potential problems and the intervention is complex, primary outcome is difficult to determine.

NCT ID: NCT06255548 Completed - Anxiety Clinical Trials

Immersive Virtual Reality and Music During Circumcision in Children

Start date: August 20, 2022
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to examine the effectiveness of immersive virtual reality (IVR) and music on children's anxiety, fear, and pain levels during circumcision surgery. The main question[s] it aims to answer are: 1. Are immersive virtual reality and music interventions effective in reducing children's anxiety and fear levels during circumcision surgery? 2. Are immersive virtual reality and music interventions effective in reducing children's pain levels during circumcision surgery? There were three groups in the study: control group (n:24), immersive virtual reality group (n:24), and music group (n:24). The control group did not undergo any intervention and only the routine procedure of the clinic was performed. The participants in the immersive virtual reality group played an interactive video game. The participants in the music group listened to music of their preference.

NCT ID: NCT06252766 Completed - Child Clinical Trials

A Clown Accompanying Children During Blood Collection

Start date: December 15, 2023
Phase: N/A
Study type: Interventional

Children may be exposed to acute and chronic illnesses during their development and may experience negative emotions and They may be exposed to experiences. For the purpose of diagnosis and treatment in a child admitted to hospital due to illness blood sampling causes pain and anxiety. To reduce pain and anxiety pharmacologic and nonpharmacologic methods are preferred in children. Nonpharmacologic methods supportive, cognitive and physical, although they are more preferred than pharmacological methods in order to classify them as such. Various methods are used within the scope of these classifications, among which The method of distraction is more preferred. This study is based on distraction the effect of the clown, which is one of the methods, on pain and anxiety during blood sampling. to determine the impact of the project. It is planned to be conducted as a randomized controlled study and in this study, 5-12 years old with children between the ages of 18 and 18, and the Pediatric Outpatient Clinic at Necmettin Erbakan University Faculty of Medicine. It was planned to be conducted in the blood collection unit. Minimum number of children to be included in the study The intervention group was planned as 28 and the control group as 28, but due to the possibility of data loss, 15 To collect more data, the number of children to be recruited for both groups is targeted to be 32-33. Children will be randomly assigned to the groups and the assignment to the groups will be based on 'stratification and blocked randomization methods' were planned to be used. Sociodemographic characteristics in data collection form, Wong-Baker Faces Pain Scale (WBFPS), Child Anxiety Scale-Dispositional (CAS-D) scales were planned to be used. Obtaining necessary institutional permissions by the researcher and project advisor It is planned to start the project after it is ensured. Research data were collected through face-to-face interviews with the 'Informed Consent Form'. Family 'Informed Voluntary Consent Form' about the research will be informed. In the intervention group, the blood collection process will be carried out with foamy bubbles accompanied by a clown. by playing with the parents. No treatment was applied to the control group and the parents blood sampling will be performed in the presence of the child. Both groups will be administered the WBFPS and CAS-D scales, will be administered by both the researcher and the parent. The research results to be obtained will be published in international SSCI and/or SCI publishing them as scientific articles in journals, organizing national and international conferences, symposiums and contributing to the literature as a result of being presented in seminars, raising awareness in this field, creating a It is aimed to shed light on future research.

NCT ID: NCT06205264 Not yet recruiting - Child Clinical Trials

Impact of Functional Strength Training Speeds on Executive Functions in 6-12-Year-Old Children.

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

The cognitive development in children involves fundamental changes in their thinking and understanding of the environment, enhancing skills such as attention, memory, and problem-solving. This development is linked to intelligence and mental processes, positively affecting academic performance. The prefrontal cortex, the seat of executive functions, undergoes maturation, crucial for planning and behavior regulation. Factors such as rest, language learning, and physical activity influence these functions. The study highlights the interconnection between executive functions and cognitive development in children, emphasizing the importance of early stimulation. Physical activity, especially strength training, emerges as a determinant in improving cognition and executive functions, with intensity playing a crucial role. Therefore, the aim is to investigate the effect of strength training, focusing on increased intentional execution speed compared to a constant low-speed approach.

NCT ID: NCT06203743 Not yet recruiting - Child Clinical Trials

Evaluation of Caudal Block and Ilioinguinal-ilioohypogastric Nerve Block Efficacy With Perfusion Index (PI)

Start date: January 18, 2024
Phase: N/A
Study type: Interventional

The study is a prospective, randomised, controlled double-blind clinical trial. The primary aim was to evaluate the efficacy of caudal block and ilioinguinal-iliohypogastric nerve block with PI and PVI in pediatric inguinal hernia operations under general anesthesia. The secondary aim is to evaluate postoperative analgesic agent consumption and to evaluate the correlation of PI and PVI values with hemodynamic parameters. Pediatric patients between the ages of 2-8 years who are planned to undergo elective inguinal hernia operation will be included in the study. After the patients scheduled for inguinal hernia surgery are admitted to the operating room, routine monitoring will be performed as performed. In addition to routine monitoring, a Radical-97TM Pulse CO-OximeterTM (Masimo Corp, Irvine, CA, USA) probe will be attached to the toe to monitor PI and PVI. Patients will be given anaesthetic drugs as routinely administered. After LMA by randomisation by closed envelope method, caudal or ilioinguinal-iliohypogastric nerve block will be performed by an experienced anaesthetist as the investigators routinely perform in patients other than the control group.. PI, PVI, pulse, saturation, noninvasive arterial pressure values will be recorded before induction, after induction, after LMA, before applied block, after applied block (after surgical incision) at 0, 5, 10, 15, 20, 25 and 30 minutes and at the end of anaesthesia. All patients will be given paracetamol 10mg/kg iv, which is a routine intravenous (iv) analgesic, at the end of surgery. In case of perioperative complications, the complications will be recorded. Flacc pain scale (Face, Legs, Activity, Cry, Consolability) will be applied at 0, 2, 6 hours postoperatively. Postoperative analgesic use and discharge time will be recorded. Flacc pain scale will be performed by an anaesthetist blinded to the study.

NCT ID: NCT06164600 Recruiting - Clinical trials for Urinary Tract Infections

Bovine Colostrum for Prophylaxis Against Recurrent Urinary Tract Infection in Children

Start date: June 1, 2023
Phase: Phase 2
Study type: Interventional

Prebiotics as bovine colostrum are considered as a valuable supplement in the prevention of upper respiratory tract infections, gastrointestinal tract infections and neonatal sepsis. It contains many bioactive substances, such as immunoglobulins, lactoferrin, lysozyme, lactoperoxidase, and other growth factors.There is a lack of research on the use of prebiotics for prophylaxis against recurrent urinary tract infection (UTI) in children.In this era of increasing bacterial resistance to antimicrobial therapy, bovine colostrum can offer an approach for prophylaxis against UTI in these patients.We aim at this trial to evaluate the efficacy and safety of bovine colostrum as a prebiotic for prophylaxis against recurrent urinary tract infection in children.

NCT ID: NCT06127173 Recruiting - Anesthesia Clinical Trials

Effect of PEEP on Gastric Insufflation During Face Mask Induction of General Anesthesia in Children

Start date: October 10, 2023
Phase: N/A
Study type: Interventional

The aim of our study is first to assess the effect of different PEEP levels on gastric volume using ultrasonography during induction of general anesthesia in children undergoing elective surgery

NCT ID: NCT06092671 Not yet recruiting - Anesthesia Clinical Trials

Effect of Family-centered Perioperative Care for Anesthesia (FPCA) on Incidence of Emergency Delirium and Postoperative Maladaptive Behaviors in Children After Surgery

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

Emergency delirium (ED) is one of the most common postoperative complications in pediatric patients and is associated with an increase of hospitalization time, healthcare costs, and increased incidence of postoperative maladaptive behaviors (POMBs). There is no clear pharmacological or non-pharmacological interventions that are effective in reducing the incidence of ED or POMBs. Therefore, the investigators aimed to assess whether family-centered perioperative care for anesthesia (FPCA) reduce the incidence of ED or POMBs in children compared with conventional preoperative pharmacological interventions.