Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-01 @ 11:44 AM
Study NCT ID:
NCT04287166
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-08
First Post:
2020-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Remote At-risk Diagnosis for Cerebral Palsy in Follow-up Clinics for High-risk Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D009069', 'term': 'Movement Disorders'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2020-02-25', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scorable video for remote GMA', 'timeFrame': '1 week'}, {'measure': 'Correlation of computer software data between standard video set-up and handheld smartphone video.', 'timeFrame': '1 week'}, {'measure': 'Predictability of GMA and computer-based assessment for development of CP', 'timeFrame': '2 years'}, {'measure': 'Predictability of GMA and computer-based assessment for development of CP', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diagnosis', 'Videos', 'Smartphone app', 'Movement', 'Movement disorders', 'Infants'], 'conditions': ['Cerebral Palsy']}, 'referencesModule': {'references': [{'pmid': '38987721', 'type': 'DERIVED', 'citation': 'Adde L, Aberg KB, Fjortoft T, Grunewaldt KH, Lade R, Osland S, Piegsa F, Sandstrom PG, Stoen R, Storvold GV, Eriksen BH. Implementation of remote general movement assessment using the in-motion instructions in a high-risk norwegian cohort. BMC Pediatr. 2024 Jul 10;24(1):442. doi: 10.1186/s12887-024-04927-4.'}]}, 'descriptionModule': {'briefSummary': 'Cerebral Palsy (CP) is the most common motor dysfunction in childhood. Traditionally, diagnosis is set between 12 and 24 months of age. This study will evaluate feasibility of a new screening procedure for early detection of CP in high-risk infants and investigate how such a procedure can be implemented in the Central Norwegian Regional Health Authority (CNRHA).\n\nThe most accurate method to detect and predict CP at an early age is the General Movement Assessment (GMA). GMA is based upon expert observations of infant spontaneous movements in a video. In Central-Norway such expertise is today only present at St. Olavs Hospital, Trondheim University Hospital. Video recordings by health personnel and parents will be used in follow-up programs within CNRHA for remote expert based GMA. In addition, machine learning models will be applied for automatic detection of CP.\n\nEarly identification of CP will lead to improved function and increased possibility to direct health care resources to the patients who need it most, independent of geographical and expert based constraints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Months', 'minimumAge': '0 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'High-risk infants referred to high-risk follow-up at discharge from one of the participating Neonatal Intensive Care Units, are candidates for enrollment. Following review of the inclusion and exclusion criteria, eligible subjects will be invited to participate. All subjects (parents) must give written informed consent prior to any study procedures being carried out.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hospitalized at a Neonatal Intensive Care Unit (NICU) within the Central Norway Regional Health Authority that is referred to follow-up in the Specialist Health Services containing a team of minimum a pediatrician and a physiotherapist.\n* at high-risk for adverse neurological outcomes as considered by the pediatrician on the basis of clinical judgement (example: serious asphyxia, prematurity, stroke, brain hemorrhage)\n\nExclusion Criteria:\n\n* Peripheral neuromotor disease e.g. brachial plexus injury\n* iatrogenic restricted movements (e.g. cast for clubfoot)'}, 'identificationModule': {'nctId': 'NCT04287166', 'acronym': 'In-Motion', 'briefTitle': 'Early Remote At-risk Diagnosis for Cerebral Palsy in Follow-up Clinics for High-risk Infants', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'Feasibility of Remote Early At-risk Diagnosis for Cerebral Palsy in High-risk Infant Follow-up Clinics in The Central Norway Regional Health Authority', 'orgStudyIdInfo': {'id': 'REK 62240'}}, 'contactsLocationsModule': {'locations': [{'city': 'Ålesund', 'country': 'Norway', 'facility': 'Department of Pediatrics, Møre and Romsdal Hospital Trust', 'geoPoint': {'lat': 62.47225, 'lon': 6.15492}}, {'city': 'Levanger', 'country': 'Norway', 'facility': 'Department of Pediatrics, Nord-Trøndelag Hospital Trust', 'geoPoint': {'lat': 63.74644, 'lon': 11.29963}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': "Department of Pediatrics, St. Olav's Hospital Trust", 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Lise Støylen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'St Olavs Hospital, Clinic of Clinical Services'}, {'name': 'Torstein Rø IKOM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology, IKOM'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alesund Hospital', 'class': 'OTHER'}, {'name': 'Helse Nord-Trøndelag HF', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}