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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Confidential Enquiry into Maternal and Child Health.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Confidential Enquiry into Maternal and Child Health
ClinicalTrials.gov Identifier:
NCT00831168
First received: January 27, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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 Intervention Phase
Premature Babies
Behavioral: Effects of Active Dissemination
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Confidential Enquiry into Maternal and Child Health:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2005
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Effects of Active Dissemination
    No medical intervention involved. It is purely information based.
  Eligibility

Ages Eligible for Study:   22 Weeks to 27 Weeks
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Richard Congdon, CEMACH
ClinicalTrials.gov Identifier: NCT00831168     History of Changes
Other Study ID Numbers: BEADI2005
Study First Received: January 27, 2009
Last Updated: January 27, 2009
Health Authority: England: The Confidential Enquiry into Maternal and Child Health

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

ClinicalTrials.gov processed this record on August 01, 2014