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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified January 2009 by Confidential Enquiry into Maternal and Child Health.
Recruitment status was: Active, not recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00831168

First Posted: January 28, 2009

Last Update Posted: January 28, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Confidential Enquiry into Maternal and Child Health

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 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.

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 ]


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:

No medical intervention involved. It is purely information based.

Eligibility

Information from the National Library of Medicine

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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

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


Responsible Party:	Richard Congdon, CEMACH
ClinicalTrials.gov Identifier:	NCT00831168 History of Changes
Other Study ID Numbers:	BEADI2005
First Submitted:	January 27, 2009
First Posted:	January 28, 2009
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

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