Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT01305720
Status:
UNKNOWN
Last Update Posted:
2011-03-01
First Post:
2011-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Mydriatic Eye Drops on Cerebral and Mesenteric Oxygenation in Preterm Infants
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-02-28', 'studyFirstSubmitDate': '2011-02-28', 'studyFirstSubmitQcDate': '2011-02-28', 'lastUpdatePostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Effect of Mydriatic Eye Drops on Cerebral and mesenteric Oxygenation', 'timeFrame': 'one year', 'description': 'By NIRS cerebral and mesenteric oxygenation will be measured before, during and after mydriatic eye drops are instilled.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mydriatic', 'NIRS', 'preterm', 'eye drops', 'cerebral', 'mesenteric oxygenation'], 'conditions': ['Prematurity of Fetus']}, 'descriptionModule': {'briefSummary': 'Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral and mesenteric oxygenation in newborn infants. Using this technique the investigators investigated the effect of mydriatic eye drops on cerebral and mesenteric oxygenation in preterm infants', 'detailedDescription': 'The cerebral and mesenteric oxygenation will be measured by NIRS before, during and after the mydriatic eye drops are instilled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '90 Days', 'minimumAge': '28 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. \\< 32 gestational age and/or \\< 1500gr.\n2. ≥ 28th day preterm infants\n3. Instilled mydriatic eye drops for ROP examination\n\nExclusion Criteria:\n\n1. Sepsis\n2. Shock\n3. Severe intracranial hemorrhage\n4. NEC\n5. Abdominal and cranial surgery'}, 'identificationModule': {'nctId': 'NCT01305720', 'briefTitle': 'The Effect of Mydriatic Eye Drops on Cerebral and Mesenteric Oxygenation in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': "Zekai Tahir Burak Women's Health Research and Education Hospital"}, 'officialTitle': 'The Effect of Mydriatic Eye Drops on Cerebral and Mesenteric Oxygenation in Preterm Infants', 'orgStudyIdInfo': {'id': '734'}}, 'armsInterventionsModule': {'interventions': [{'name': 'near infrared spectroscopy: invos 5100', 'type': 'DEVICE', 'description': 'NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, the investigators applied NIRS probes to the forehead and abdomen for cerebral (rSO2C) and abdominal (rSO2P) regional oxygen saturation measurements.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Hatice Tatar Aksoy, MD', 'role': 'CONTACT', 'email': 'haticetatar@yahoo.com', 'phone': '0905327114054'}, {'name': 'Hatice Tatar Aksoy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zekai Tahir Burak Maternity and Teaching Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Hatice Tatar Aksoy, MD', 'role': 'CONTACT', 'email': 'haticetatar@yahoo.com', 'phone': '0905327114054'}, {'name': 'Ugur Dilmen, Prof.', 'role': 'CONTACT', 'email': 'ugurdilmen@gmail.com', 'phone': '0903123065270'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Zekai Tahir Burak Women's Health Research and Education Hospital", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Zekai Tahir Burak Maternity and Teaching Hospital', 'oldOrganization': 'Zekai Tahir Burak Maternity and Teaching Hospital'}}}}