Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-02-28 @ 9:48 AM
Study NCT ID:
NCT00503100
Status:
TERMINATED
Last Update Posted:
2015-05-21
First Post:
2007-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Somatosensory Evoked Potentials and Pain Thresholds in Term and Preterm-Born Adolescents After Early Exposure to Pain; a Quantitative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Difficulties in recruiting', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-20', 'studyFirstSubmitDate': '2007-07-17', 'studyFirstSubmitQcDate': '2007-07-17', 'lastUpdatePostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C).', 'timeFrame': 'During the test'}], 'secondaryOutcomes': [{'measure': 'Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel).', 'timeFrame': 'At time of the test'}, {'measure': 'Pain threshold to tactile stimulation will be measured by using Von-Frey hairs', 'timeFrame': 'At time of the test'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pain', 'Preterm-Born Adolescents'], 'conditions': ['Somatosensory Disorders']}, 'descriptionModule': {'briefSummary': 'Background: Several studies have indicated that infants who had undergone postnatal painful procedures appear to be hypersensitive to pain, with a lower threshold to tactile stimulations later on life.\n\nObjective: To study the effect of early exposure to pain on cerebral somatosensory evoked potential (SEP) response to thermal stimulation (550C), in preterm and full term born adolescents (15-18 years old), who have undergone painful procedures during their neonatal period. As well as to study the effect of early exposure to thermal and tactile sensory thresholds and pain thresholds to thermal and tactile stimuli, by using the TSA and von Frey hairs.\n\nDesign: Case-control study.\n\nParticipants: Four groups of 20 adolescents (aged 15-18 years), two of which are full term and preterm-born who were exposed to painful procedures during the neonatal period. The other two groups are term and preterm-born adolescents who were not exposed to such procedures.\n\nMain Outcome Measures: Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel). Pain threshold to tactile stimulation will be measured by using Von-Frey hairs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Four groups of 20 adolescents (aged 14 years or older), two of which are full term and preterm-born who were exposed to painful procedures during the neonatal period. The other two groups are term and preterm-born adolescents who were not exposed to such procedures.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor all:\n\n* Age 15-18\n* Appropriate weight for gestational age (AGA)\n* Informed consent signed by the parent\n* Presence of one parent during the examination\n\nPremature groups:\n\n* Preterm-born (32-34 weeks of gestation)\n* Admitted to the NICU (ventilated vs. non-ventilated)\n\nFull term groups:\n\n* Completed 37 weeks of gestation Pain groups (premature and full term)\n* Admitted to the NICU\n* Mechanically-ventilated during the first week of life\n* Mechanically-ventilated for at least 48 hours\n\nExclusion Criteria:\n\n* Current use of analgesia\n* A chronic illness with current medical treatment\n* Cognitive impairment'}, 'identificationModule': {'nctId': 'NCT00503100', 'briefTitle': 'Somatosensory Evoked Potentials and Pain Thresholds in Term and Preterm-Born Adolescents After Early Exposure to Pain; a Quantitative Study', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'orgStudyIdInfo': {'id': 'SOR458107CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NICU full-term early pain group', 'interventionNames': ['Device: Thermal stimulation']}, {'label': 'NICU premature early pain group', 'interventionNames': ['Device: Thermal stimulation']}, {'label': 'NICU premature control group', 'interventionNames': ['Device: Thermal stimulation']}, {'label': 'Soroka- full-term control group', 'interventionNames': ['Device: Thermal stimulation']}], 'interventions': [{'name': 'Thermal stimulation', 'type': 'DEVICE', 'description': 'Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel). Pain threshold to tactile stimulation will be measured by using Von-Frey hairs.', 'armGroupLabels': ['NICU full-term early pain group', 'NICU premature control group', 'NICU premature early pain group', 'Soroka- full-term control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84105', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Ben Gurion University of the Negev, Siaal research center for family medicine and primary care', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'overallOfficials': [{'name': 'Pesach Shvartzman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ben-Gurion University of the Negev'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head Department of Family Medicine', 'investigatorFullName': 'Pesach Shvartzman', 'investigatorAffiliation': 'Soroka University Medical Center'}}}}