[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cystic-fibrosis-in-children\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cystic-fibrosis-in-children":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,44,73,101,124,161,182,209],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100521217","19f-mri-in-healthy-children-and-children-with-mild-cystic-fibrosis-lung-disease-100521217",false,"NCT06066723","19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease","A Cross-sectional Pilot Study of 19F MRI in Healthy Children and Children With Mild Cystic Fibrosis Lung Disease","Inclusion Criteria:\n\n* 6-17 years old\n* Non-smoker and non-vaper\n* Cystic Fibrosis (CF) Group: must have a diagnosis of CF\n* No use of supplemental oxygen\n* They must be able to perform spirometry and have stable lung function (within 10% personal best in the last 6 months) and no exacerbations within the past 4 weeks\n* Baseline forced expiratory volume in 1 second (FEV1) \\>80% with ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lung (FEV1:FVC) ratio \\>0.7\n\nExclusion Criteria:\n\n* Healthy volunteers: with any history of chronic lung disease (i.e. asthma)\n* Active or former smoker with less than 1 year of quitting\n* Unable to undergo an MRI of the lungs and chest because of contraindications, including:\n\n  * Injury to the eye involving a metallic object\n  * Injury to the body involving a metallic object\n  * Presence of an implanted drug infusion device that is not MRI safe\n  * Bone growth of fusion simulator\n  * Presence of cochlear, otologic, or ear implant\n  * Shunt (spinal or intraventricular)\n  * Any implant held in place by magnet\n  * Claustrophobia\n* Unable to tolerate the inhalation of the gas mixture\n* Facial hair preventing a tight fit of the mask used in the study\n* Pregnancy\n* Changes in medication that may affect CF lung disease or lung function in the past 28 days, including experimental therapies",true,"ALL","6 Years","17 Years",{"count":21,"type":22},15,"ESTIMATED","OBSERVATIONAL","This study capitalizes on the emerging technology of 19F MRI, using conventional 'thermally' polarized perfluorinated gas (perfluoropropane, or PFP) mixed with oxygen and studied with magnetic resonance imaging (MRI) to visualize ventilation. This technique has not been studied in children.\n\nChildren and adolescents (6-17 years old) with cystic fibrosis (CF) who have normal spirometry will undergo 19F MRI with the inhalation of an inert contrast gas to study ventilation. Comparisons will be made to a cohort of healthy children (6-17 years old) who will perform the same measures. The primary outcome measure is the feasibility of conducting these studies in the pediatric population. Parallel performance of multiple breath nitrogen washout (MBW) and spirometry will be used to compare the sensitivity of these outcomes to the presence of mild lung disease in these children. Finally, the investigators will compare data obtained during standard breath holds with a novel \"free-breathing\" technique that will eliminate the need for breath holds during MRI acquisition.",[26],"Cystic Fibrosis in Children",[28,29,30],"19F MRI","ventilation","pediatrics","RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":35},"2025-06-16",{"date":39,"type":22},"2026-08",{"name":41,"class":42},"University of North Carolina, Chapel Hill","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100530811","sinus-disease-in-young-children-with-cystic-fibrosis-100530811","NCT06191640","Sinus Disease in Young Children With Cystic Fibrosis","Inclusion Criteria:\n\nHEMT Group:\n\n* Children with documentation of a CF diagnosis\n* Age 2-8 years old at first study visit\n* CFTR mutation consistent with FDA labeled indication of highly effective modulator therapy (ivacaftor or elexacaftor\u002Ftezacaftor\u002Fivacaftor)\n* Clinician intent to prescribe ivacaftor or ETI so that enrollment is before start of HEMT\n\nNon-HEMT\u002FControl Group:\n\n* Children with documentation of a CF diagnosis\n* Age 2-8 years at first study visit\n* Ineligible for highly effective modulator therapy (ivacaftor or elexacaftor\u002Ftezacaftor\u002Fivacaftor) based on CFTR mutation or clinical decision not to initiate HEMT if eligible\n\nExclusion Criteria:\n\nFor Both Groups:\n\n* Use of an investigational drug within 28 days prior to the first study visit\n* Use of ivacaftor or elexacaftor\u002Ftezacaftor\u002Fivacaftor within the 180 days prior to and including the first study visit\n* Use of chronic oral corticosteroids within the 28 days prior to and including the first study visit.\n* Sinus surgery within 180 days prior to the first study visit","2 Years","8 Years",{"count":53,"type":22},80,"This is a prospective, observational study examining the impact of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators on chronic rhinosinusitis (CRS) and olfactory dysfunction (OD) in young children with cystic fibrosis (YCwCF). This study involves two groups: children 2-8 years old, inclusive at initial visit, receiving highly effective modulator therapy (HEMT), and a control group of children 2-8 years old, inclusive at initial visit, not receiving HEMT. Outcomes will include sinus magnetic resonance imaging (MRI) scans, olfactory tests, and quality of life surveys obtained over a two-year period.",[26,56,57,58,59],"Cystic Fibrosis","Chronic Rhinosinusitis (Diagnosis)","Olfactory Disorder","Olfactory Impairment",[56,61,62],"Chronic Rhinosinusitis","Olfactory Dysfunction","2026-05-06",{"date":65,"type":35},"2026-05-11",{"date":67,"type":35},"2023-04-12",{"date":69,"type":22},"2029-06-30",{"name":71,"class":42},"University of California, Los Angeles",6,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":43},"100591765","physical-impairments-in-children-with-cystic-fibrosis-100591765","NCT06984679","Physical Impairments in Children With Cystic Fibrosis","Comparison of Dyspnea, Functional Capacity, Muscle Strength, Urinary Incontinence and Quality of Life Between Children and Adolescents With Cystic Fibrosis and Healthy Children","Inclusion Criteria for Children and Adolescents with Cystic Fibrosis:\n\n* To be between the ages of 6-18\n* To have been diagnosed with cystic fibrosis\n* To be clinically stable for at least 3 weeks\n* To have the necessary cooperation for the measurements\n* To volunteer to participate in the study\n\nInclusion Criteria for Healthy Children and Adolescents:\n\n* To be between the ages of 6-18\n* To be in a similar average and ratio with the group of children and adolescents with cystic fibrosis in terms of age and gender\n* To have the necessary cooperation for the measurements\n* To volunteer to participate in the study\n\nExclusion Criteria for Children and Adolescents with Cystic Fibrosis:\n\n* Having any orthopedic, neurological, psychological or cardiovascular problem that may prevent the measurements from being performed in the last 6 months\n* Smoking or quitting smoking\n\nExclusion Criteria for Healthy Children and Adolescents:\n\n* Having any orthopedic, neurological, psychological or cardiovascular problem that may prevent the measurements from being performed in the last 6 months\n* Having any chronic disease\n* Smoking or quitting smoking","18 Years",{"count":82,"type":22},50,"It is aimed to reveal impairments regarding urinary incontinence, dyspnea, muscle strength, functional capacity or quality of life in children and adolescents with cystic fibrosis compared to healthy children and adolescents.",[85,26],"Cystic Fibrosis (CF)",[56,87,88,89,90,91],"Urinary Incontinence","Dyspnea","Muscle Strength","Quality of Life","Exercise Test","2026-03-23",{"date":94,"type":35},"2026-03-27",{"date":96,"type":35},"2025-09-15",{"date":98,"type":22},"2027-03-03",{"name":100,"class":42},"Izmir Democracy University",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":80,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":122,"locationsCount":43},"100563503","gerd-in-children-with-cystic-fibrosis-100563503","NCT06617013","GERD in Children With Cystic Fibrosis","Characteristics of Gastroesophageal Reflux in Children With Cystic Fibrosis","Inclusion Criteria:\n\n* Children 2-18 years of age with a confirmed CF diagnosis by either a positive sweat test or 2 disease causing CFTR mutations.\n* Signed consent\n\nExclusion Criteria:\n\n* Declining to participate in the study or sign consent\n* History of severe GERD per gastroenterology diagnosis and documentation\n* GSAS score \\>80",{"count":109,"type":22},20,"INTERVENTIONAL",[112],"NA","The purpose of this study is to evaluate the prevalence of gastroesophageal reflux disease (GERD) symptoms in pediatric patients with cystic fibrosis using the Gastroesophageal Symptom Assessment Scale (GSAS) and the impact of stopping anti-GERD therapy on the GERD symptoms reported.",[115,26],"GERD in Children","2025-12-12",{"date":118,"type":35},"2025-12-19",{"date":120,"type":35},"2024-10-23",{"date":32,"type":22},{"name":123,"class":42},"Duke University",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":110,"phases":135,"briefSummary":136,"conditions":137,"keywords":141,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100517648","internet-delivered-cystic-fibrosis-mental-health-prevention-wellness-resource-program-how-does-it-work-100517648","NCT06020274","Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, Resource Program: How Does it Work?","Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, Resource (iCF-PWR) Program: How Does it Work?","iCF-PWR","Inclusion Criteria:\n\n* between the ages of 8 and 12\n* have a CF diagnosis or are a sibling of a child with CF\n* can speak and read English. The research team does not have competence in other languages, further our program is delivered in English\n\nExclusion Criteria:\n\n* have a severe cognitive impairment or a major comorbid medical or psychiatric illness, as this may impede their ability to fully participate in the program and evaluation process","12 Years",{"count":134,"type":22},120,[112],"The goal of the clinical trial is to test whether a mental health program that is delivered through the Internet works well for children and adolescents with cystic fibrosis (CF) and their healthy siblings. The main questions it aims to answer are:\n\n* Does the program improve the mental health such as depression and anxiety symptoms?\n* Does the program improve overall quality of life?\n* Does the program improve self-efficacy - an individual's belief in their ability to complete tasks to achieve their goals?\n\nParticipants will:\n\n* Fill out an online survey asking questions about their personal and health information, as well as their mental health before the program\n* Complete the online mental health program\n* Fill out an online survey asking questions about their mental health after completing the program, and 1-month and 3-months following completing the program\n\nParticipants be compared against another group of children with CF and their healthy siblings who are on a waitlist and receiving usual CF treatment. Researchers will compare participants scores before starting the program with their scores immediately following completing the program, 1-month, and 3-month after completing the program. Researchers hope to develop a program that improves mental health, quality of life, self-efficacy, and knowledge about CF.",[26,138,139,140],"Siblings","Mental Health","Internet-based Intervention",[142,143,144,145,146,147,148,149],"cystic fibrosis","child","adolescent","siblings","mental health","Internet-based intervention","anxiety","depression","NOT_YET_RECRUITING","2025-06-05",{"date":153,"type":35},"2025-06-10",{"date":155,"type":22},"2025-06-01",{"date":157,"type":22},"2027-06-30",{"name":159,"class":42},"University of Regina",2,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":16,"sex":17,"minAge":168,"maxAge":80,"enrollmentInfo":169,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":43},"100561205","feasibility-of-cough-monitoring-in-children-100561205","NCT06587126","Feasibility of Cough Monitoring in Children","Assessing the Feasibility of Home Nighttime Cough Monitoring in Children with Cystic","Inclusion Criteria for Children with Cystic Fibrosis\n\n* Diagnosis of CF based on 2 known CFTR mutations and\u002For sweat chloride \\> 60 mmol\u002FL\n* Ages 1-18 years of age\n* Clinically stable at the time of consent\n\nExclusion Criteria\n\n* Use of nocturnal positive pressure or supplemental oxygen\n* Shared bedroom with sibling\n* Use of oral or IV antibiotics within the past 2 weeks except for chronic azithromycin use\n* Shared custody (i.e., the participant is splitting time between time households)\n\nInclusion Criteria for Healthy Controls\n\n* Ages 1-18\n\nExclusion Criteria:\n\n* Shared bedroom with sibling\n* Underlying chronic respiratory or cardiac conditions including chronic cough, CF, asthma, obstructive sleep apnea, or congenital heart disease or other condition felt by the investigator to cause chronic nighttime symptoms\n* Shared custody (i.e., the participant is splitting time between time households)","1 Year",{"count":170,"type":22},40,"Cystic fibrosis (CF) is a disease characterized by chronic airway infection and impaired mucociliary clearance, which predisposes those affected to recurrent pulmonary exacerbations (PEx) and progressive decline in lung function. Treatment with elexacaftor\u002Ftezacaftor\u002Fivacaftor (ETI) results in decreases in patient-reported cough and PEx. Despite this, increased cough remains the most common symptom associated with acute PEx and worsening lung disease. Cough frequency was historically difficult to measure due to reliance on human input. Recent advances in audio capture and signal processing have made automated cough detection possible. As a result there's been a surge in development of portable cough monitors, as cough is increasingly recognized as a measurable parameter of respiratory disease. The majority of cough monitors have been designed for use in adults, and little is known about the practicality of collecting cough data in the pediatric population. In this study investigators aim to assess the feasibility of using an in-home device to capture nighttime cough frequency in children with and without CF. Investigators plan to compare nighttime cough frequency between children with and without CF and, among children with CF, and determine the association between cough frequency and baseline lung function. Additionally, investigators aim to evaluate the changes in nighttime cough frequency in relationship to respiratory symptom scores surrounding clinician diagnosed pulmonary exacerbations. This study will provide important preliminary data needed for a larger study assessing the utility of home cough monitoring for clinical care and for use of cough as a clinical outcome measure in research studies.",[26],"2024-09-04",{"date":175,"type":35},"2024-09-19",{"date":177,"type":35},"2024-02-27",{"date":179,"type":22},"2024-12",{"name":181,"class":42},"University of Colorado, Denver",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":80,"enrollmentInfo":189,"targetDuration":4,"studyType":110,"phases":190,"briefSummary":191,"conditions":192,"keywords":193,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":43},"100537957","quality-of-life-and-gut-health-in-pediatric-patients-with-cystic-fibrosis-100537957","NCT06284577","Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis","Probiotic Supplementation, Quality of Life and Gut Health in Pediatric Patients With Cystic Fibrosis","Inclusion criteria for WP1:\n\n* CFTR mutations eligible for treatment with ETI\n* Age 2-18 years. Majority of patients will be 2-6 years of age as ETI was approved from 6 years of age in 2022, and will be available for children above 2 years from 2024.\n* Included in the Norwegian CF Register and consented to participation in CF general research biobank\n\nExclusion criteria for WP1:\n\n* Other CFTR modulators commenced the last 6 months before inclusion\n* Use of probiotics or prebiotics last 2 months\n* Current pulmonary exacerbation\n\nInclusion criteria for WP2:\n\n* Age 3-18 years\n* CFTR modulator treatment naïve or treated with CFTR modulator for at least 6 months\n* Included in the Norwegian CF Register and consented to participation in CF general research biobank\n\nExclusion criteria for WP2:\n\n* CFTR modulators commenced the last 6 months before inclusion\n* Use of probiotics or prebiotics last 2 months\n* Current pulmonary exacerbation",{"count":170,"type":22},[112],"The aim of the present study is to investigate the effect of probiotic supplementation on GI related quality of life, through a randomised placebo-controlled clinical trial. Moreover, the invetigators wish to study CF microbiota and intestinal inflammation in the setting of probiotic supplementation and newly started treatment with a highly effective CF-specific treatment, elexacaftor-tezacaftor-ivacaftor (ETI). The proposed project has the potential to increase QoL and decrease GI morbidity in children with CF. If successful, the results of this study can contribute to alter the care of CF patients by including supplementation of probiotics in routine CF care. Morever, the study can provide much needed insights to GI microbiota and inflammation in pediatric CF patients.",[26],[56,194,195,196,197,198,199],"Children","Microbiota","Quality of life","Probiotic supplement","CFTR modulators","elexacaftor-tezacaftor-ivacaftor","2024-06-12",{"date":202,"type":35},"2024-06-13",{"date":204,"type":35},"2024-01-02",{"date":206,"type":22},"2027-07-01",{"name":208,"class":42},"Oslo University Hospital",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":17,"minAge":216,"maxAge":217,"enrollmentInfo":218,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":220,"conditions":221,"keywords":222,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":160},"100350221","detection-of-unsuspected-small-airways-obstruction-in-cystic-fibrosis-100350221","NCT03839992","Detection of Unsuspected Small Airways Obstruction in Cystic Fibrosis","The Measurement and Analysis of Maximal Expiratory Flow Volume Loops at Low Lung Volumes in Children With Cystic Fibrosis and Normal Routine Lung Function.","Inclusion Criteria:\n\nHeterozygote or homozygote patients with cystic fibrosis with normal routine pre bronchodilator spirometry including normal FEV1(L), FVC(L) and FEV1\u002FFVC%.\n\nExclusion Criteria:Heterozygote or homozygote patients with cystic fibrosis with ABNORMAL routine pre bronchodilator spirometry\n\n\\-","5 Years","40 Years",{"count":219,"type":22},100,"Goal is to physiologically detect unsuspected small airways obstruction in children and adults with treated heterozygous and homozygous cystic fibrosis. Unsuspected refers to normal routine pre bronchodilator spirometry including normal FEV1(L), FVC (L). and FEV1\u002FFVC%. This is a retrospective study.",[26],[223,224,225],"abnormal FEF75","bronchiectasis","lung CT","2023-10-25",{"date":228,"type":35},"2023-10-26",{"date":230,"type":35},"2018-04-25",{"date":232,"type":22},"2027-11-25",{"name":234,"class":235},"Gelb, Arthur F., M.D.","INDIV"]