Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-26 @ 10:33 AM
Study NCT ID:
NCT06674928
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2024-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Developmental Trajectory of Gene and Life Participation in Children With Developmental Delay
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007859', 'term': 'Learning Disabilities'}], 'ancestors': [{'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Samples with DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2024-11-04', 'studyFirstSubmitQcDate': '2024-11-04', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score of participation (< 3y)', 'timeFrame': 'baseline', 'description': 'Children Assessment of Participation and Enjoyment and Preferences for Activity of Children (Higher scores means a better outcome.)'}, {'measure': 'Score of participation (3y > 15y)', 'timeFrame': 'Baseline', 'description': 'Pediatric Quality of Life Inventory TM (Scores from 0 to 102, higher scores mean a better outcome.)'}], 'secondaryOutcomes': [{'measure': 'Gene Test', 'timeFrame': 'Baseline', 'description': 'Whole-Exome Sequencing (Use Burrows-Wheeler Aligner (BWA) 85, Samtools86, Picard, Genome Analysis Toolkit (GATK) to screen out the variant discovery and genotyping.)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Developmental delay', 'Life participation', 'Quality of life', 'Whole-exome sequencing', 'Gene', 'Children Development'], 'conditions': ['Genetics', 'Life Participation']}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to learn the factors affecting the quality of life in children's development.\n\nThe main hypothesis for this study is:\n\nIf the level of well-being increases in age, could the quality of life be enhanced in terms of function and participation?\n\nParticipant will be given assessment every year for five years in total. No intervention will be given during the whole study period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Control and experimental group', 'healthyVolunteers': False, 'eligibilityCriteria': 'Normal developing children\n\nInclusion Criteria:\n\n* Agreeing in consent\n* In the age range of 6-15 years old\n\nExclusion Criteria:\n\n* Diseases of Central Nervous System\n* Diseases of Neuromuscular\n* Nature deficit disorder\n* Genetic Disorder\n* Sensory Integration disorder\n* Auditory disorder\n\nDevelopment delay children\n\nInclusion Criteria:\n\n* Agreeing in consent\n* In the age range of 6-15 years old\n* Diagnosed of Developmental Delay\n\nExclusion Criteria:\n\n* Diseases of Central Nervous System\n* Diseases of Neuromuscular\n* Nature deficit disorder\n* Genetic Disorder\n* Sensory Integration disorder\n* Auditory disorder'}, 'identificationModule': {'nctId': 'NCT06674928', 'briefTitle': 'Developmental Trajectory of Gene and Life Participation in Children With Developmental Delay', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Developmental Trajectory of Gene and Life Participation in Children With Developmental Delay', 'orgStudyIdInfo': {'id': '202301017A3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal Developing Children', 'description': 'Children that were satisfied with the criteria as average or "on-time" growth based on the attainment of specific physical, cognitive, linguistic, social-emotional, and behavioral milestones across specific stages.'}, {'label': 'Developmental Delay Children', 'description': 'Children who has not gained the developmental skills expected of him or her, compared to others of the same age.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Chia-Ling Chen, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}