Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 7:04 PM
Study NCT ID:
NCT00699127
Status:
WITHDRAWN
Last Update Posted:
2008-07-04
First Post:
2008-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Organizing the Information Given to Parents of NICU Infants in Order to Reduce Their Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'After a discussion, we decided to withdraw the study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2008-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-07-03', 'studyFirstSubmitDate': '2008-06-14', 'studyFirstSubmitQcDate': '2008-06-16', 'lastUpdatePostDateStruct': {'date': '2008-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between questionnaires at the first week and the last week to hospitalization.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anxiety', 'parents', 'NICU', 'prematurity', 'Anxiety of parents to NICU infants'], 'conditions': ['Anxiety']}, 'descriptionModule': {'briefSummary': "Being a parent to a premature infant in NICU is an anxious state. Parents ask a lot of questions, and look for information all the time. Organizing the information given to parents could reduce their anxiety. The parents will be divided into two groups: one group will get organized information, by a lecture at the first week of their infant's life, and the other group will not. Of course, questions will be answered all the time. The parents will answer a questionnaire on the first week of the infant's life, and on the last week, just before releasing the infant home.", 'detailedDescription': "Being a parent to a premature infant in NICU is an anxious state. Parents ask a lot of questions, and look for information all the time. Organizing the information given to parents could reduce their anxiety. The parents will be divided into two groups: one group will get organized information, by a lecture at the first week of their infant's life, and the other group will not. Of course, questions will be answered all the time. The parents will answer a questionnaire on the first week of the infant's life, and on the last week, just before releasing the infant home."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents to premature infants, after releasing the mother\n\nExclusion Criteria:\n\n* Term infants\n* Hospitalized mother'}, 'identificationModule': {'nctId': 'NCT00699127', 'briefTitle': 'Organizing the Information Given to Parents of NICU Infants in Order to Reduce Their Anxiety', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Dose Organizing the Information Given to Parents of NICU Infants Reduce Their Anxiety?', 'orgStudyIdInfo': {'id': 'HY-19-2008-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'The group that will have lecture of information regarding infants in NICU.', 'interventionNames': ['Behavioral: Lecture']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'The group that will not have lecture of information regarding NICU hospitalization'}], 'interventions': [{'name': 'Lecture', 'type': 'BEHAVIORAL', 'description': 'Lecture of information regarding prematurity, NICU hospitalization, etc.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'state': 'Hadera', 'country': 'Israel', 'facility': 'Hillel Yaffe medical center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'overallOfficials': [{'name': 'Erez Nadir, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hillel Yaffe medical center, Hadera, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Erez Nadir, MD', 'oldOrganization': 'Hillel Yaffe medical center'}}}}