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Child, Only clinical trials

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NCT ID: NCT05908708 Recruiting - Type 1 Diabetes Clinical Trials

Closed-loop Medtronic 780G System in Youth With Type 1 Diabetes

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

The goal of this observational study is to describe data on Israeli children and youth using the 780G system including data regarding glycemic control parameters, various questionnaires, sleep data, bioimpedance measures, and dietary parameters. The main questions it aims to answer are: • whether the 780G system will improve glycemic control • whether the psychosocial aspects will improve. Participants will be followed once connected to 780G, at baseline, one, three, and six months after the connection.

NCT ID: NCT05904483 Recruiting - Anxiety Clinical Trials

The Effects of Finger Puppet, Abeslang Puzzle, and Pinwheel on Pain and Anxiety During Blood Sampling Procedures

Start date: June 20, 2023
Phase: N/A
Study type: Interventional

Blood sampling is an invasive, diagnostic, and therapeutic procedure for children. The inability of preschool children to differentiate between reality and imagination and their belief in the power of their thoughts make it difficult for them to accept an invasive procedure. Distraction techniques are used to help children cope with pain and anxiety. The aim of this study is to compare the effects of finger puppet, abeslang puzzle, and pinwheel on pain and anxiety during blood sampling in preschool children presenting to the pediatric emergency department. This randomized controlled study used parallel trial design.

NCT ID: NCT05895032 Recruiting - Child, Only Clinical Trials

Trial of an Exercise Intervention for Children With Haemophilia

DOLPHIN-II
Start date: May 6, 2021
Phase: N/A
Study type: Interventional

"Being able to participate in games and activities with their friends" is one of the things that matters most to boys with haemophilia. At present, there is a lack of robust evidence to determine whether muscle strengthening exercise can improve or negatively affect outcomes for young children with haemophilia. With the help of boys with haemophilia, their parents and physiotherapists the investigators have developed an exercise programme designed to increase muscle strength. Using this intervention the investigators will undertake a single-blinded, two-arm pragmatic randomised controlled trial (RCT) of a 12-week intervention verses usual care of boys with haemophilia aged 6-12 years of age.

NCT ID: NCT05882929 Recruiting - Surgery Clinical Trials

The Effect of Distraction in the Postoperative Period of Pediatric Patients Undergoing Outpatient Surgery

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

The aim of the study is to examine the effects of distraction methods such as watching cartoons and ball squeezing on the level of pain and physiological parameters in the postoperative period in children aged 6-12 years who have outpatient surgery. The research is a randomized controlled trial. The sample number was determined as 40 children (total 120) in each group. Information Form, Physiological Parameters Follow-up Form, Wong-Baker Faces Pain Scale will be used to collect research data. In the initiative group, two attempts will be implemented, namely watching cartoons and squeezing the ball. Interventions will be implemented for a total of 15 minutes. Physiological Parameters Follow-up Form and Wong-Baker Faces Pain Scale will be filled in before the interventions are applied, 10 minutes during the intervention and 5 minutes after the intervention is completed. In the control group, the 10th and 20th minute physiological parameters and the Wong-Baker Faces Pain Scale will be evaluated after the child comes to the service after the operation and is prepared for the postoperative period (taking vital signs, putting on clothes, controlling bleeding, telling the feeding time, etc.). In the analysis of study data; chi-square test for descriptive statistics, chi-square test for repeated measurements, single factor analysis of variance, Mann-Whitney U test and Friedman will be used. In the study, values at the p<0.05 level were considered statistically significant.

NCT ID: NCT05761847 Recruiting - Child, Only Clinical Trials

Pediatric Medication Therapy Management Trial

pMTM
Start date: September 11, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate whether an intervention called Pediatric Medication Therapy Management (pMTM) improves the identification and management of medication-related problems among children with medical complexity and polypharmacy.

NCT ID: NCT05747560 Recruiting - Child, Only Clinical Trials

Study on the Effect of Dietary Supplements on Height Improvement in Children

Start date: June 20, 2023
Phase: N/A
Study type: Interventional

With the increasing improvement of living standard, more and more people are concerned about the body height of their children. It has been reported that 542 out of 1000 children (54.2%) failed to meet the standards of height. Moreover, nearly 80% was disappointed with the height of their children. The body height of child is mainly influenced by 60% of genetic factors (6 out of 10) and 40% of acquired factors which includes nutrition, exercise, sleep, psychology, disease and so on. Therefore, it is an important way to solve the problem by regulating the acquired factors. At present, inject growth hormone (GH) for children is the main way to solve the problem of children's body weight. However, high price, complex operation skills, and side effects limits the implication of GH. Additionally, the effect of traditional Chinese medicine therapy, exercise therapy, and dietary supplement are of dubious benefit and without clinical support. Elevated insulin like growth factor-1 (IGF-1) levels in the human body have been recognized as one of the core criteria for evaluating body enhancement therapy. Currently, there is no dietary supplement intervention to enhance the sensitivity of GH receptor and IGF-1 receptor. The goal of this clinical trial is to test the effect of dietary supplements on height improvement in children (aged 8-15 years of both genders). The main question it aims to answer is: Study the effect of dietary supplements (a formula based on enhancing the sensitivity of GH receptor and IGF-1 receptor) on height improvement in children by. Participants will be randomly divided into three groups: Placebo, Astragalus extract, and Wolfiporia extract. 1. Participants in the Placebo will consume placebo (a look-alike substances that contains no active drug) at a dose of 500 mg, twice a day (morning and evening) for 6 months. Participants in the Astragalus extract will take dietary supplement with astragalus extract at a dose of 450 mg, twice a day for the same duration. Participants in the Wolfiporia extract will take dietary supplement with wolfiporia extract at a dose of 15 g, twice a day for the same duration. 2. Taken blood sample at the timepoint of baseline (Day 0), intermediate point (Day 90), intervention end point (Day 180)) to detect biochemical markers, as well as body height and weight, and skeletal age. 3. Throughout the trial, subjects were asked to keep their usual lifestyle, food, and physical exercise and not took any dietary supplements. Researchers will compare the effects of Placebo with Astragalus extract, placebo with Wolfiporia extract, and Astragalus extract with Wolfiporia extract to see if Astragalus extract and Wolfiporia extract increase children's height, and whether Astragalus extract or Wolfiporia extract is more works well.

NCT ID: NCT05729581 Recruiting - Child, Only Clinical Trials

Effectiveness of Educational Intervention on Sustainable Breastfeeding: The GREEN MOTHER Project

Start date: April 11, 2022
Phase: N/A
Study type: Interventional

Breastfeeding is the healthiest form of nutrition for the baby and is recommended to use exclusive breastfeeding (EB) until 6 months. The environmental footprint of artificial lactation (AL) has been studied, but that of EB is unknown. Objectives: The main objective of the first phase of the study is to identify the environmental impact in terms of the carbon footprint of breastfeeding and artificial breastfeeding, taking into account the accessories necessary for breastfeeding and of the diet and the factors associated with the diet of postpartum women in first month of life of the babies. The main objective of the second phase is to evaluate the impact of a standardized intervention of educational programme on sustainable breastfeeding, diet and environment protection, providing inputs obtained from the first phase on the carbon footprint in the first month of life of the child and the prevalence of breastfeeding at the first month of the baby's life.

NCT ID: NCT05724017 Recruiting - Nursing Caries Clinical Trials

Determining the Effect of Street Play Intervention on Children's Play Tendencies and Social Problem Solving Levels

Start date: November 17, 2022
Phase: N/A
Study type: Interventional

Determining the Effect of Street Play Intervention on Children's Play Tendencies and Social Problem Solving Levels: I Learn to Solve My Problems by Playing Project

NCT ID: NCT05552287 Recruiting - Crohn Disease Clinical Trials

Pharmacokinetic Infliximab Data in Pediatric Crohn's Disease

ProRAPID
Start date: August 2, 2023
Phase: Phase 4
Study type: Interventional

Rationale: Crohn's disease (CD) is a chronic, debilitating inflammatory bowel disease (IBD) which is diagnosed during childhood in up to one in ten patients. The use of anti-tumor necrosis factor (TNF)-α agents has significantly ameliorated CD management. Infliximab (IFX) is the first anti-TNF-α agent registered for pediatric CD. The current dosing recommendation of IFX is extrapolated from adult studies, and it is a weight-based dose (5 mg/kg) delivered during induction (infusion at weeks 0, 2, and 6) and maintenance (every 8 weeks). However, pediatric patients have a 25-40% lower drug exposure compared to adults, particularly children under 10 years of age, resulting in diminished efficacy and an increased risk of developing a complicated disease course. The investigators hypothesize that an intensified IFX induction scheme (instead of the current dosing recommendation) is more effective in the treatment of pediatric CD patients. Objective: The primary study objective of our study is to assess the efficacy of an IFX intensified induction scheme vs. a standard dosing schedule in improving drug exposure without treatment escalation in pediatric CD patients. Secondary objectives are clinical and biochemical remission without treatment escalation, development of antibodies to IFX (ATI) and adverse reactions. Study design: An international, multicenter, prospective, open-label trial. Study population: Anti-TNF-α naïve children (age 3-15 years) with CD and an indication to start IFX treatment. Intervention: IFX will be given intravenously at 10 mg/kg at week 0, and 5 mg/kg at weeks 2, 4, and 8 to all patients (induction). Maintenance will start at week 12, and then ideally continue every 6 weeks till week 24 (end of study). IFX trough levels will be measured at weeks 4, 12, and 24. During the maintenance, the IFX dose and/or interval adjustments, the IFX discontinuation or the start of a co-medication (i.e., an immunomodulator) will be possible on indication (i.e., primary nonresponse, secondary loss of response, intolerance to study medication) at the physicians' discretion. Follow-up will continue for the duration of the study (week 24). Main endpoint: Proportion of patients with IFX TL ≥ 5 µg/mL at week 12 without treatment escalation.

NCT ID: NCT05522465 Recruiting - Clinical trials for Immune Thrombocytopenia

Short-course High-dose Prednisone and Dexamethasone in Children With ITP

Start date: October 11, 2022
Phase: Phase 4
Study type: Interventional

Comparison of the efficacy and safety of short-course high-dose prednisone and dexamethasone in the treatment of children with newly diagnosed immune thrombocytopenia (ITP)