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

Primary Purpose

Premature Babies

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Effects of Active Dissemination
Sponsored by
Confidential Enquiry into Maternal and Child Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Premature Babies focused on measuring neonatal, premature babies, healthcare research, Babies born before 27 weeks gestation

Eligibility Criteria

22 Weeks - 27 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Outcomes

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 27, 2009
    Last Updated
    January 27, 2009
    Sponsor
    Confidential Enquiry into Maternal and Child Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00831168
    Brief Title
    BEADI - The Bliss Cluster Randomised Control Trial on the Effects of Active Dissemination of Information (BEADI)
    Acronym
    BEADI
    Official Title
    The Bliss Cluster Randomised Control Trial on the Effects of Active Dissemination of Information on Outcomes of Premature Babies.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2005 (undefined)
    Primary Completion Date
    March 2009 (Anticipated)
    Study Completion Date
    March 2009 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Confidential Enquiry into Maternal and Child Health

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Babies
    Keywords
    neonatal, premature babies, healthcare research, Babies born before 27 weeks gestation

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Effects of Active Dissemination
    Intervention Description
    No medical intervention involved. It is purely information based.
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Weeks
    Maximum Age & Unit of Time
    27 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dominique Acolet
    Organizational Affiliation
    Confidential Enquiry into Maternal and Child Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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