Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-24 @ 7:16 PM
Study NCT ID:
NCT00550069
Status:
UNKNOWN
Last Update Posted:
2007-12-27
First Post:
2007-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Infants Born at 34 to 37 Weeks of Gestation Until the Age of 1 Year
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D007565', 'term': 'Jaundice'}, {'id': 'D007035', 'term': 'Hypothermia'}, {'id': 'D007859', 'term': 'Learning Disabilities'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2009-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-12-24', 'studyFirstSubmitDate': '2007-10-25', 'studyFirstSubmitQcDate': '2007-10-25', 'lastUpdatePostDateStruct': {'date': '2007-12-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neurodevelopmental, health and growth status in late preterm infants vs. controls within the first year of life', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['late preterm infants', 'near term infants', 'outcome'], 'conditions': ['Respiratory Distress', 'Hypoglycemia', 'Feeding Intolerance', 'Jaundice', 'Hypothermia', 'Developmental Delay']}, 'descriptionModule': {'briefSummary': 'Late preterm infants are at an increased risk for short and long term morbidity (during the 1st year of life, their neurodevelopmental status may also be delayed as compared to infants born at term). The term "near term infants" is probably a deceiving one.', 'detailedDescription': 'The study will include all near term infants born at 3 Israeli medical centers during a one year period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'minimumAge': '1 Hour', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All infants born at a gestational age of 34-37 weeks in 3 medical centers in Israel', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age 34wks- 37wks\n* Singleton\n* Without chromosomal abnormalities or malformations\n\nExclusion Criteria:\n\n* No chromosomal abnormalities\n* Malformations'}, 'identificationModule': {'nctId': 'NCT00550069', 'briefTitle': 'Observational Study of Infants Born at 34 to 37 Weeks of Gestation Until the Age of 1 Year', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Late Preterm Infants:Clinical Course and Outcome From Birth Through Out the First Year of Life.', 'orgStudyIdInfo': {'id': 'SHEBA-07-4821-IM-CTIL'}}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'contacts': [{'name': 'Iris Morag, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'centralContacts': [{'name': 'Iris Morag, MD', 'role': 'CONTACT', 'email': 'irismorag@gmail.com', 'phone': '+972-52-666-7393'}, {'name': 'Lidia Gavis, MD', 'role': 'CONTACT', 'email': 'lidia.gavis@health.gov.il', 'phone': '052-666-7360'}], 'overallOfficials': [{'name': 'Iris Morag, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr. Iris Morag', 'oldOrganization': 'Sheba Medical Cener'}}}}