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Child, Only clinical trials

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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)

NCT ID: NCT05507489 Recruiting - COVID-19 Clinical Trials

Clinical Trial of Jinzhen Oral Liquid in Treating Children With COVID-19 Infection

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

Jinzhen oral liquid and Jinhuaqinggan Granules were used in the treatment and the control group for 14 days, respectively, to evaluate the effect of Jinzhen oral liquid in treating children with novel coronavirus infection.

NCT ID: NCT05380466 Recruiting - Anxiety Clinical Trials

The Effect of "Quantum Touch" Application on Transfer Anxiety in Pediatric Patients and Their Parents Planned to be Hospitalized in the Emergency Department

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

Anxiety, which is a subjective experience in which many emotions such as worry, uncertainty, restlessness, and sadness are experienced together, is defined as "a state of tension that arises as a result of the internal conflict experienced by the individual". Emergency services are the units where all kinds of patients and injured are followed and treated 24 hours a day, and anxiety is a very common emotional reaction in patients who apply to the emergency department and their relatives. The patient and his family; They experience varying levels of anxiety due to a sudden and unexpected deterioration of health, the threat of their life, the uncertainty of the situation, the fear of death, role changes, disruption of routines, and being in an unfamiliar hospital environment. With the increase of anxiety, distraction in family members, repetitive questions to health personnel, inability to understand the importance of the event and difficulty in making decisions can be seen.Leaving the emergency room as well as being in the emergency room causes anxiety in individuals. The anxiety experienced in this situation is called transfer anxiety. Transfer anxiety is often defined as "anxiety experienced by an individual when he/she moves from a safe and familiar environment to an unfamiliar environment" and was accepted as a nursing diagnosis by NANDA in 1992. Transferring the patient from the emergency room to the clinic is a routine procedure for emergency nurses, but it causes anxiety for the patient and their relatives. As a result of transfer anxiety, many patients and their family members experience widespread confusion both before and after transfer and tend to certain problems. The patient and family members experience anxiety when they are in a foreign environment with different routines and follow-up procedures for the first time and do not know what to expect. Pharmacological and non-pharmacological methods are used to reduce anxiety. Cognitive behavioral therapy techniques are frequently used among non-pharmacological methods. Cognitive-behavioral therapies are a form of treatment developed on the basis of behavioral psychological counseling theory, which is problem-focused, deals with the "here and now" and applies learning theories to help individuals when they encounter difficulties and life problems that they cannot overcome in their daily lives. Cognitive-behavioral therapies that are highly suitable for working with children, youth, adults, the elderly and families; They are easy to work with individually or in groups and do not require any hardware. Among cognitive behavioral therapy techniques, therapy strategies that reduce anxiety include relaxation, biofeedback, systematic desensitization, exercise, vestibular desensitization, response prevention, and therapeutic touch techniques. Therapeutic touch; In 1972, it was started to be used as a healing method by the manipulation of hypothetical human bioenergy field by nurse professor Doores Krieger. In the literature, it is frequently applied to reduce pain and anxiety in nursing studies and successful results are obtained. Quantum-Touch; It is one of the therapeutic touch techniques and is a biofield therapy that uses life force energy to facilitate healing. Quantum-Touch was first described by Richard Gordon and Bob Rasmusson in 1978; It activates life force energy by combining various hand positions, various breathing techniques and body awareness exercises. It is applied by directing the formed high energy field to an area of pain, stress or illness through therapeutic touch. Tully (2017) found that Quantum Touch in reducing acute and chronic pain; Walton (2011) reported that Quantum-Touch application is effective in chronic musculoskeletal pain. The patient and/or the patient's family may be physically ready for relocation in the hospital environment, but they are not psychologically ready. Inadequate preparation of the individual for the transfer from the emergency room to the clinic or lack of information about the transfer, perceiving that his safety is under threat, and experiencing uncertainty about his situation cause transfer anxiety. Although it is seen in the literature that transfer anxiety is applied in adults and generally in intensive care units, no study has been found in children and emergency services.

NCT ID: NCT05336136 Recruiting - Child, Only Clinical Trials

Custom Non-invasive Ventilation Masks in Children

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

One significant challenge to non-invasive ventilation (NIV) use in children is finding masks to fit a wide range of growing shapes and sizes. While the technology has improved with development of masks specifically for children, the range of options remains limited. Given the smaller size relative to adults, craniofacial abnormalities and craniofacial differences are more likely to compromise mask fit for children. A poor mask fit is uncomfortable, alters delivery of airway pressure, and, in some children, leads to failure of NIV and the need for surgical insertion of an airway in the neck to deliver positive airway pressure through a tracheostomy. This makes expanding the technology to deliver NIV vital and custom NIV masks an exciting solution.In this study, this study will enroll children who are established on long-term NIV with at least some use within 3 months of starting this therapy but who have non-optimal adherence. After consenting to participate and completing demographic and health questionnaire, participants will undergo a facial scan using stereophotogrammetry. This scan will be imported into a computer-aided design software to create a NIV mask customized to the individual face. The steps of mask testing will include: i) Bench testing to compare the leak and comfort parameters of the current commercial mask used by the participant to the custom mask: ii) Efficacy of treatment as measured by polysomonography iii) NIV compliance from machine downloads; iv) Questionnaires to assess the subjective comfort, fit, and adverse events Finally, participants and their parents/guardian will be asked which mask they prefer and why.

NCT ID: NCT05329467 Recruiting - Pain Clinical Trials

Validation of Pain Assessment Scale Faces Thermometer Scale (FTS)

Start date: September 17, 2021
Phase: N/A
Study type: Interventional

The aim of the study was to psychometrically evaluate the electronic self assessment Faces Pain Scale (FPS). Validation is performed in relation to golden standard of pain scale assessments Faces Pain Scale Reversed (FPS-R) and Coloured analogue Scale (CAS). 600 children with a range of illnesses on various paediatric healthcare settings in Sweden, Island, Denmark and USA will be included. Pain assessment will take place postoperatively, in relation to procedures or in a setting where acute pain is identified.

NCT ID: NCT05308108 Recruiting - Surgery Clinical Trials

Study of Postoperative Respiratory Complications in Children With Obstructive Sleep Apnea (PORC)

PORC
Start date: May 2, 2022
Phase:
Study type: Observational [Patient Registry]

Adenotonsillectomy is the first line surgical treatment for children with Obstructive Sleep apnea Syndrome (OSAS). Postoperative respiratory complications (PORC) may occur and are often related to co-morbidities. Despite guidelines from different scientific groups, there is no consensus on the monitoring requirements and management of PORC in these children.