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BEADI - The Bliss Cluster Randomised Control Trial on the Effects of Active Dissemination of Information (BEADI) (BEADI)

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ClinicalTrials.gov Identifier: NCT00831168
Recruitment Status : Unknown
Verified January 2009 by Confidential Enquiry into Maternal and Child Health.
Recruitment status was:  Active, not recruiting
First Posted : January 28, 2009
Last Update Posted : January 28, 2009
Sponsor:
Information provided by:
Confidential Enquiry into Maternal and Child Health

Study Description
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Brief Summary:

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.

BEADI 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.

The 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.


Condition or disease Intervention/treatment Phase
Premature Babies Behavioral: Effects of Active Dissemination Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Bliss Cluster Randomised Control Trial on the Effects of Active Dissemination of Information on Outcomes of Premature Babies.
Study Start Date : October 2005
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : March 2009
Arms and Interventions
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Intervention Details:
  • Behavioral: Effects of Active Dissemination
    No medical intervention involved. It is purely information based.

Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   22 Weeks to 27 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Hospital staff : Lead neonatologist for clinical governance in each maternity hospital in England.
  • Babies born in England before 27 weeks gestation between January 2006 - 31st March 2007
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00831168


Sponsors and Collaborators
Confidential Enquiry into Maternal and Child Health
Investigators
Principal Investigator: Dominique Acolet Confidential Enquiry into Maternal and Child Health
More Information
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Responsible Party: Richard Congdon, CEMACH
ClinicalTrials.gov Identifier: NCT00831168     History of Changes
Other Study ID Numbers: BEADI2005
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: January 28, 2009
Last Verified: January 2009

Keywords provided by Confidential Enquiry into Maternal and Child Health:
neonatal
premature babies
healthcare research
Babies born before 27 weeks gestation

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications