Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-28 @ 10:32 AM
Study NCT ID:
NCT00332150
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2006-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mothers' Approach to Clinical Research Amongst Their Preterm or Healthy Newborns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-23', 'studyFirstSubmitDate': '2006-05-31', 'studyFirstSubmitQcDate': '2006-05-31', 'lastUpdatePostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['parents', 'newborn', 'clinical trials'], 'conditions': ['Parents Approval to Research']}, 'referencesModule': {'references': [{'pmid': '9096174', 'type': 'BACKGROUND', 'citation': 'Zupancic JA, Gillie P, Streiner DL, Watts JL, Schmidt B. Determinants of parental authorization for involvement of newborn infants in clinical trials. Pediatrics. 1997 Jan;99(1):E6. doi: 10.1542/peds.99.1.e6.'}, {'pmid': '18310179', 'type': 'DERIVED', 'citation': 'Maayan-Metzger A, Kedem-Friedrich P, Kuint J. Motivations of mothers to enroll their newborn infants in general clinical research on well-infant care and development. Pediatrics. 2008 Mar;121(3):e590-6. doi: 10.1542/peds.2007-1571.'}]}, 'descriptionModule': {'briefSummary': "Parental approval to enroll their sick children in clinical research was studied. However, the motivation of parents to enroll healthy children and/or babies was not yet studied. The importance of clinical research among the healthy population is of extreme value. The aim of this study is to assess the motivation, medical trust and other factors influencing parents' decision to enroll their healthy baby in a clinical study.", 'detailedDescription': 'Mothers to either healthy full-term babies post delivery or preterms will be asked to anonymously answer a questionnaire. The questionnaire includes demographic data, questions regarding their approach to medical issues, factors that influence her to enroll her baby in a research trial (different research types, different benefits from the research and fears). Finally, the mother will be asked if she will be willing to enroll her baby to on-going studies in the department.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mothers to healthy newborns during hospital stay after delivery, and mothers of preterm infants during their hospitalization in NICU.\n\nExclusion Criteria:\n\n* Mothers of sick newborns (respiratory distress, receiving IV infusion, etc.) who are in the special care for newborns.'}, 'identificationModule': {'nctId': 'NCT00332150', 'briefTitle': "Mothers' Approach to Clinical Research Amongst Their Preterm or Healthy Newborns", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': "Mothers' Approach to Clinical Research Amongst Their Preterm or Healthy Newborns", 'orgStudyIdInfo': {'id': 'SHEBA-06-4076-AM-CTIL'}}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'overallOfficials': [{'name': 'Ayala Maayan, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr. Ayala Maayan', 'oldOrganization': 'Sehba Medical Center'}}}}