Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT03577756
Status:
COMPLETED
Last Update Posted:
2021-04-12
First Post:
2018-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neurodevelopmental Assessment of Infants With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-09', 'studyFirstSubmitDate': '2018-06-23', 'studyFirstSubmitQcDate': '2018-06-23', 'lastUpdatePostDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gross motor function measure (GMFM) score', 'timeFrame': 'about 30 minutes', 'description': 'It consists of a total of 88 items in the supine-posed position and during rotation, 17 items in sitting, 20 items in sitting, 14 items in crawling and kneeling, 13 items during standing, 24 items during walking-running-jumping. The child is scored according to the degree of achievement of gross motor functions in these materials. If the child can not initiate the activity 0 is given, can initiate independently 1 is given, can partially complete 2 is given, can independently complete 3 is given.'}, {'measure': 'The Bayley Scales of Infant Development, Third Edition (BSID III)', 'timeFrame': 'about 30 minutes', 'description': "The Bayley-III includes Cognitive, Language, Motor, Social-Emotional, and Adaptive Behavior scales.\n\nCognitive. The Cognitive scale of the Bayley-III contains 91 items. Language. This subtest contains 48 items. The Expressive Communication subtest assesses the individual's ability to vocalize, name pictures and objects, and communicate with others.\n\nMotor. The Bayley-III Motor scale include Fine Motor and Gross Motor subtests. The Fine Motor subtest contains 66 items and is purported to measure skills associated with eye movements, perceptual-motor integration, motor planning, and motor speed. The Gross Motor subtest contains 72 items and is designed to measure movements of the limbs and torso.\n\nSocial-Emotional. This scale include 35 items, which measure emotional development and related behaviors.\n\nAdaptive Behavior. Bayley-III include the Adaptive Behavior Assessment System-Second Edition as a measure of adaptive skills."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cystic fibrosis', 'neurodevelopment', 'early rehabilitation'], 'conditions': ['Neurodevelopmental Disorders', 'Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '3592448', 'type': 'BACKGROUND', 'citation': 'Sitrin MD, Lieberman F, Jensen WE, Noronha A, Milburn C, Addington W. Vitamin E deficiency and neurologic disease in adults with cystic fibrosis. Ann Intern Med. 1987 Jul;107(1):51-4. doi: 10.7326/0003-4819-107-1-51.'}, {'pmid': '21680118', 'type': 'BACKGROUND', 'citation': 'de Almeida Thomazinho P, de Miranda Chaves CR, Passaro CP, Meio MD. Motor delay in cystic fibrosis infants: an observational study. Early Hum Dev. 2011 Dec;87(12):769-73. doi: 10.1016/j.earlhumdev.2011.05.012. Epub 2011 Jun 15.'}, {'pmid': '9374570', 'type': 'BACKGROUND', 'citation': 'Singer L, Yamashita T, Lilien L, Collin M, Baley J. A longitudinal study of developmental outcome of infants with bronchopulmonary dysplasia and very low birth weight. Pediatrics. 1997 Dec;100(6):987-93. doi: 10.1542/peds.100.6.987.'}, {'pmid': '35385120', 'type': 'DERIVED', 'citation': 'Tekerlek H, Yardimci-Lokmanoglu BN, Inal-Ince D, Ozcelik U, Mutlu A. Developmental Functioning Outcomes in Infants With Cystic Fibrosis: A 24- to 36-Month Follow-Up Study. Phys Ther. 2022 Jun 3;102(6):pzac037. doi: 10.1093/ptj/pzac037.'}]}, 'descriptionModule': {'briefSummary': 'Infants included in the study will be divided into two groups as healthy infants and cystic fibrosis infants . Demographic, natal and postnatal information of the infants will be available from patient files. 12 months infants with cystic fibrosis and healthy infants will be assessed by the Bayley-III Baby and Child Development Assessment Scale (Bayley III) and the Gross Motor Function Measure. The assessment outcomes of healthy and cystic fibrosis infants will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '24 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Infants with cystic fibrosis will be provided from the Hacettepe University Faculty of Medicine, Pediatric Chest Diseases Clinic and healthy infants will be provided from the Hacettepe University Department of Physiotherapy and Rehabilitation Developmental and Early Physiotherapy Unit.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* having diagnosis of cystic fibrosis\n* to be postterm24-36 months old\n\nExclusion Criteria:\n\n* Having congenital anomalies,\n* Having an acute infection,\n* Risk of high or low neurological impairment due to perinatal stroke, perinatal asphyxia, intra / peri-ventricular hemorrhage (IVH / PVL), bronchopulmonary dysplasia,\n* The baby's family not reluctant to involved in study."}, 'identificationModule': {'nctId': 'NCT03577756', 'briefTitle': 'Neurodevelopmental Assessment of Infants With Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Neurodevelopmental Assessment Outcomes of Infants With Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'earlyrehabcysticfibrosis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infants with cystic fibrosis', 'description': 'Twelve months infants with cystic fibrosis will be assessed by the Bayley-III Baby and Child Development Assessment Scale (Bayley III) and the Rough Motor Function Measure.', 'interventionNames': ['Other: Neurodevelopmental assessments']}, {'label': 'Healthy infants', 'description': 'Twelve months healthy infants will be assessed by the Bayley-III Baby and Child Development Assessment Scale (Bayley III) and the Rough Motor Function Measure.', 'interventionNames': ['Other: Neurodevelopmental assessments']}], 'interventions': [{'name': 'Neurodevelopmental assessments', 'type': 'OTHER', 'description': "Infants' neurodevelopmental assessments will be done by the Bayley-III Baby and Child Development Assessment Scale (Bayley III) and the Gross Motor Function Measure. Bayley-III assess the development of five distinct scales to be consistent with areas of appropriate developmental assessment for children from birth to age 3. The Bayley-III revision includes Cognitive, Language, Motor, Social-Emotional, and Adaptive Behavior scales.The Gross Motor Function Measure (GMFM) has 5 dimensions: A-lying and roll- ing; B-sitting; C- kneeling and crawl- ing; D-standing; and E-walking, run- ning, and jumping. The items are scored from 0 to 3. All items are summarized and expressed as a value of total points for each dimension of the GMFM.", 'armGroupLabels': ['Healthy infants', 'Infants with cystic fibrosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Akmer Mutlu', 'investigatorAffiliation': 'Hacettepe University'}}}}