Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-25 @ 3:23 AM
Study NCT ID:
NCT03172767
Status:
COMPLETED
Last Update Posted:
2018-04-12
First Post:
2017-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between School Readiness and Sensory Processing Disorder in Preterm Preschooler
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-10', 'studyFirstSubmitDate': '2017-05-26', 'studyFirstSubmitQcDate': '2017-05-31', 'lastUpdatePostDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Marmara Primary School Readiness Scale', 'timeFrame': '45 minutes', 'description': 'The application form includes math skills, science skills, voice exercises, line exercises and labyrinths; Development form; Mental-language development, socio-emotional development, physical development, self-care skills.'}], 'secondaryOutcomes': [{'measure': 'Sensory profile caregiver questionnaire', 'timeFrame': '45 minutes', 'description': "The profile reveals the child's sensory appearance in terms of sensory search, emotional response formation, low endurance, oral tenderness, distractibility, weak perception, sensory sensitivity, activity level and fine motor / perceptual differences. In addition, the child evaluates the senses (sensory processing), adjustment (modulation), behavioral and emotional responses."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preterm', 'Sensory processing', 'School Readiness'], 'conditions': ['Sensory Deficit', 'Preterm Birth']}, 'descriptionModule': {'briefSummary': 'The study aims investigate sensory processing disorders and school readiness in pre-school preterm children and the relationship between sensory impairment and school readiness', 'detailedDescription': 'A convenience of preterm and term preschoolers recruiting from Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation. Each group contains 30 children. First, sociodemographic information and histories of children are obtaining. Ages and contact information of the parents are recording. Prenatal and natal risk factors of the mothers are querying. Gestational ages and height, weight, and head circumferences of babies at birth are recording. Number of pregnancies, live births and abortions, type of delivery, multiple pregnancies for mothers as well as consanguinity between parents are asking. Marmara Primary School Readiness Scale is using to evaluate mental-language development, socio-emotional development, physical development, self-care skills,math skills, science skills, voice exercises, line exercises and labyrinths. Sensory profile caregiver questionnaire screen for the senses (sensory processing), adjustment (modulation), behavioral and emotional responses. . All examination wiil be finished in the same day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '78 Months', 'minimumAge': '60 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm Preschoolers and Term Preschoolers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No neurological diagnosis\n* gestational age \\< 37 weeks\n* 60-78 months of age\n\nExclusion Criteria:\n\n* Have a neurological diagnosis (such as cerebral palsy)\n* Grade III or grade IV intraventricular hemorrhage\n* Have undergone major surgery in neonatal period\n* Mental retardation'}, 'identificationModule': {'nctId': 'NCT03172767', 'acronym': 'Preterm', 'briefTitle': 'The Relationship Between School Readiness and Sensory Processing Disorder in Preterm Preschooler', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'The Relationship Between School Readiness and Sensory Processing Disorder in Preterm Preschooler', 'orgStudyIdInfo': {'id': '5461'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preterm Preschoolers', 'description': "Preterm children who haven't attend school."}, {'label': 'Term Preschoolers', 'description': "Term children who haven't attend school."}]}, 'contactsLocationsModule': {'locations': [{'zip': '06560', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazı University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Bülent Elbasan', 'role': 'STUDY_CHAIR', 'affiliation': 'study chair'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ayse Simsek', 'investigatorAffiliation': 'Gazi University'}}}}