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Child clinical trials

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NCT ID: NCT03169491 Recruiting - Clinical trials for Sleep Apnea, Obstructive

Effect of CPAP and Adenotonsillectomy in Upper Airway Volume of Children With OSAS

Start date: July 4, 2016
Phase: N/A
Study type: Interventional

Obstructive sleep apnea syndrome (OSAS) in children has high prevalence and severe complications, and its first line of treatment (adenotonsillectomy) has risk of complications. Even though the use of presurgical CPAP seems logical due to its effects in adults, it must be studied in children due to the different physiopathology and adherence. One non-invasive way of study the effect is via acoustic pharyngometry, which can measure the anatomical site of obstruction. The post-surgical anatomical changes could correlate with a persistent OSAS, which would be helpful in selecting those patients who require a post surgical sleep study. The main goal of the study is to cuantify the changes in the oropharyngeal volume via acoustic pahryngometry after CPAP use, and also the changes after adentonsillectomy in children.

NCT ID: NCT03164343 Completed - Pain Clinical Trials

Pain Neuroscience Education in Healthy Children

Start date: August 8, 2017
Phase: N/A
Study type: Interventional

The primary objective of this study is to examine whether Pain Neuroscience Education for children is able to increase a child's knowledge on the neurophysiology of pain. In addition, this study investigates the influence of PNE on several pain related outcomes; pain-related fear, pain catastrophizing and pain vigilance and awareness.

NCT ID: NCT03162835 Completed - Pain Clinical Trials

Development and Clinimetric Properties of the Dutch Pediatric Neurophysiology of Pain Questionnaire in Healthy Children

Start date: June 12, 2017
Phase:
Study type: Observational

The scientific objective of this research implies developing and examining the clinimetric properties of the Dutch Pediatric Neurophysiology of Pain Questionnaire (PedNPQ) in healthy children. A total study sample of 60 healthy children (30 from 2nd and 3rd primary school) will be included to measure test-retest reliability of the Pediatric Neurophysiology of Pain Questionnaire (PedNPQ). Children will be asked to fill in the questionnaire twice, with a time interval of 48 hours (assessment T0 and T1). In order to assess concurrent validity of the PedNPQ, 30 children (15 from 2nd and 3rd primary school) as well as their parent will receive a pediatric Pain Neuroscience Education (PNE) session. It is hypothesized that if the developed PedNPQ is valid, children who received PNE will perform better than children receiving no PNE. To reduce the participant's workload, all assessments will be done immediately after the school hours or during recreation, in the primary school of the participant.

NCT ID: NCT03156465 Completed - Child Clinical Trials

Iowa Cochlear Implant Clinical Research Center Hybrid L24 and Standard Cochlear Implants in Profoundly Deaf Infants

Start date: September 15, 2011
Phase: N/A
Study type: Interventional

The purpose of this feasibility study is to evaluate whether implantation of one Nucleus L24 electrode array and one FDA approved standard-length device in the contralateral ear can provide useful binaural hearing in pediatric subjects who have bilateral severe to profound hearing loss, meeting the criteria for cochlear implantation. Unlike a conventional cochlear implant, the Nucleus L24 is expected to preserve the regions of the cochlear partition that are apical to the electrode, thus leaving them available for possible future advances in the field of otolaryngology and hearing devices, such as mammalian hair cell regeneration techniques or improved implantable hearing devices. Whether or not this group of children will be able to take advantage of future hair cell regeneration strategies is yet to be determined and will have to wait for future development. At this time there are no accurate imaging strategies available to identify preservation of the scala media. Ultra thin micro CT scanning is in development, however the level of radiation delivery to the subject is too great to be considered for clinical use. When imaging strategies become available to determine cellular structure of the inner ear, they will be applied to this group of subjects. The Nucleus L24 array stimulates the basal turn of the cochlea, in an attempt to preserve the middle and apical regions of the scala media.

NCT ID: NCT03080467 Completed - Child Clinical Trials

Long-Term Outcome of Pediatric Traumatic Wound Repair: Suture Versus Tissue Adhesive

Start date: June 13, 2017
Phase:
Study type: Observational

This project is an observational trial investigating wound cosmetic appearance after repair of traumatic skin lacerations in the head area of pediatric patients with two different approaches to skin closure: sutures versus tissue adhesive. Photographs will be taken at two follow-up visits after repair and later assessed by external blinded plastic surgeon using standard cosmetic assessment scales. The investigators hypothesize that cosmetic wound outcome will be equivalent in these two wound repair treatment options.

NCT ID: NCT03042624 Recruiting - Child Clinical Trials

Efficacy of Fermented Rice Flour for the Treatment of Atopic Dermatitis: Randomized, Double-blind Controlled Trial

Start date: January 24, 2017
Phase: N/A
Study type: Interventional

This trial aims at evaluating the efficacy of a fermented rice flour for the treatment of atopic dermatitis (AD). The fermented rice flour, obtained from Lactobacillus paracasei CBA L74 (Heinz Italia SpA, Latina, Italy), does not contain live bacteria. Lactobacillus paracasei CBA L74 belongs to the list of microorganisms with qualified presumption of safety compiled by the European Food Safety Authority (EFSA), is tested for the absence of antibiotic resistance genes in accordance with EFSA, and is genetically characterized by repetitive extragenic palindromic polymerase chain reaction. Using a repeated-measure cohort design, the investigators have recently shown that the administration of a fermented-rice flour obtained from Lactobacillus paracasei CBA L74 was associated with a decrease of the score for atopic dermatitis (SCORAD) in children with AD. The present randomized, double-blind, controlled trial is aimed at testing whether the fermented rice flour obtained from Lactobacillus paracasei CBA L74 is effective in reducing SCORAD in children with moderate to severe AD using placebo as comparator.

NCT ID: NCT02999789 Completed - Asthma in Children Clinical Trials

Interventions To Help Asthma Clinical Adherence

ITHACA
Start date: January 2017
Phase: N/A
Study type: Interventional

To conduct a pilot test to estimate the effect of a novel reminder system in improving daily asthma controller medication adherence rates in children with monolingual Spanish-speaking guardians who have limited English Proficiency (LEP).

NCT ID: NCT02986464 Completed - Pain Clinical Trials

Virtual Reality Distraction for Procedural Pain Management in Children With Burn Injuries: a Randomized Controlled Trial

Start date: May 3, 2018
Phase: N/A
Study type: Interventional

Procedural pain is the most intense and often undertreated pain associated with burn injuries. The use of analgesics does not always provide optimal relief and is accompanied by several side effects. Indeed, children with burn injuries still experience severe pain intensity during procedures despite the fact that doses of analgesics used with this population has almost doubled in the last twenty years. Current guidelines on pediatric procedural pain management recommend the combination of non-pharmacological and pharmacological interventions to enhance pain management and decrease the numerous side effects of analgesics. Distraction has been identified among the most effective non-pharmacological interventions for pain as it diverts the child's attention to an attractive element, hindering the perception of the painful stimuli. Virtual reality is a method of active distraction that offers the child a multi-sensory immersive interaction that found many applications for pain management in adult patients. However, very few studies have tested the efficacy of distraction by virtual reality on procedural pain and anxiety in children with burn injuries. This RCT follows a pilot study (NCT02794103) aimed at assessing the feasibility of a virtual reality prototype developed specifically for the hydrotherapy room of children under seven years old for the relief of procedural pain in children with burn injuries. The aim of the RCT will be to evaluate the effectiveness of the virtual reality prototype in relieving procedural pain in children from 6 months to 7 years old undergoing hydrotherapy session for burn injuries.

NCT ID: NCT02977923 Completed - Pain Clinical Trials

Decreasing REcurrent Pain and Anxiety in Medical Procedures With a Pediatric Population: a Pilot Study

DREAM-P
Start date: July 10, 2017
Phase: N/A
Study type: Interventional

Children with injuries, including burns, experience severe pain intensity during medical procedures despite the increasing doses of analgesics. Current guidelines on pediatric procedural pain management recommend the combination of non-pharmacological and pharmacological interventions to enhance pain management and decrease the numerous side effects of analgesics. Virtual reality (VR) has gained growing consideration as a non-pharmacological method as it engages multiple senses and allows interactions with a virtual world. Oculus Rift ® (OR) is a new technology in VR that provides more immersiveness, at a relatively low cost, and could probably improve the management of pain and anxiety in wound care. Overall hypothesis: Distraction by VR via the OR, in combination with the standard pharmacological treatment, is a feasible, acceptable and satisfactory method for the management of pain and anxiety during wound-related treatments in children with injuries. Note that this pilot study will precede a larger trial aimed at assessing the effect of virtual reality distraction via the Oculus Rift ® (DREAM-T: NCT02947243)

NCT ID: NCT02961452 Completed - Child Clinical Trials

Phenotypical Characterization of Peanut Allergic Children

Start date: January 2016
Phase: N/A
Study type: Observational

Peanut allergy (PA) has been well studied and its prevalence was estimated up to 1.3% in Europe. Tree nut (TN) allergy and PA are clinically similar and often coexist, TN allergy prevalence ranged from 0.05 to 4.9 %. TN allergy is longlasting and nearly all TN have been associated with fatal allergic reactions . Other legumes or TN also contain seed storage protein orthologs of the globulins (Ara h1, Ara h 3) and 2S albumins (Ara h 2) of peanut, susceptible to provoke allergic reactions, but cross-reactivity to TN and other legumes in PA patients could also appear through primarily sensitization. These possible IgE-binding cross-reactions bring to recommend the avoidance of TN and other legumes which have never been eaten in PA children. In this context, diagnosis work-up of relevant cross-allergy versus asymptomatic cross-sensitization will impact directly children's health-related quality of life (HRQL). When physicians suspect food allergy, many parameters have to be considered, such as clinical background, clinical history, type of symptoms related to the suspected food and cross-allergy to other foods. Then, to objectively confirm a food allergy and to assess its severity (related to the threshold reactive dose and symptoms), an oral food challenge (OFC) is demanded, and double-blind placebo-controlled food challenge (DBPCFC) is considered as "the gold standard". Although OFC are more and more available in the diagnosis of PA, the assessment of cross-allergy to every single allergenic TN and legumes requires full allergy work-up and often many years of follow-up. Few studies investigated cross-allergy to TN and other legume, with rates of cross-allergy to TN between 28% and 50%. However, targeting patients with severe or cross-allergic phenotypes would greatly assist the allergist in management and follow-up of PA patients (i.e., planning OFC to cross-reactive food). Our main objective is to identify different disease phenotypes of PA children with cluster analysis. This statistical approach has never been performed to identify cross-allergic phenotypes. We also will describe cross-allergy in PA and will identify possible risk factors for cross-allergy to TN and other legumes in PA children.