Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-03 @ 10:37 AM
Study NCT ID:
NCT00831168
Status:
UNKNOWN
Last Update Posted:
2009-01-28
First Post:
2009-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BEADI - The Bliss Cluster Randomised Control Trial on the Effects of Active Dissemination of Information (BEADI)
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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-01-27', 'studyFirstSubmitDate': '2009-01-27', 'studyFirstSubmitQcDate': '2009-01-27', 'lastUpdatePostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Assess whether an innovative 'active' strategy for the dissemination of neonatal research findings, recs and national guidelines is more likely to lead to changes in policy and practice than the traditional,passive forms of dissemination in the UK.", 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neonatal', 'premature babies', 'healthcare research', 'Babies born before 27 weeks gestation'], 'conditions': ['Premature Babies']}, 'descriptionModule': {'briefSummary': "BEADI is a dissemination trial, on standards of care of premature babies. The main objective of BEADI is to assess whether an innovative 'active' strategy for the dissemination of neonatal information (evidence reviews, interactive training workshop, benchmarking and feedback, and ongoing support) is more likely to lead to changes in policy and practice than the traditional (more passive) forms of dissemination in English neonatal units.\n\nBEADI will focus on three areas of neonatal care for premature (22+0 to 26+6 weeks' gestation) babies born in England: timing of surfactant therapy, staffing for resuscitation at delivery, and temperature control (in line with the main Project 27/28 findings ). However, the approach is applicable to a wide variety of clinical policies and practice.\n\nThe BEADI study has been granted ethical approval by MREC to use a subset of data collected by EPICure2 up until 31st December 2006 (pre-intervention data). For the post-intervention data, ethical approval has been granted for CEMACH to continue data collection against the three clinical areas using a subset of data items captured in the PN:E2 form, for the three month period between 1st January - 31st March 2007. Local research and development departments of each trust have also been contacted."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '27 Weeks', 'minimumAge': '22 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospital staff : Lead neonatologist for clinical governance in each maternity hospital in England.\n* Babies born in England before 27 weeks gestation between January 2006 - 31st March 2007'}, 'identificationModule': {'nctId': 'NCT00831168', 'acronym': 'BEADI', 'briefTitle': 'BEADI - The Bliss Cluster Randomised Control Trial on the Effects of Active Dissemination of Information (BEADI)', 'organization': {'class': 'OTHER', 'fullName': 'Confidential Enquiry into Maternal and Child Health'}, 'officialTitle': 'The Bliss Cluster Randomised Control Trial on the Effects of Active Dissemination of Information on Outcomes of Premature Babies.', 'orgStudyIdInfo': {'id': 'BEADI2005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Effects of Active Dissemination', 'type': 'BEHAVIORAL', 'description': 'No medical intervention involved. It is purely information based.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dominique Acolet', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Confidential Enquiry into Maternal and Child Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Confidential Enquiry into Maternal and Child Health', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Richard Congdon', 'oldOrganization': 'CEMACH'}}}}