Condition category
Pregnancy and Childbirth
Date applied
14/05/2007
Date assigned
05/06/2007
Last edited
08/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dominique Acolet

ORCID ID

Contact details

The Confidential Enquiry into Maternal and Child Health
Chiltern Court
188 Baker Street
London
NW1 5SD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

05/Q0605/180

Study information

Scientific title

Acronym

BEADI

Study hypothesis

The aim of BEADI is to assess whether an innovative ‘active’ strategy for the dissemination of neonatal research findings, recommendations and national neonatal guidelines is more likely to lead to changes in policy and practice than the traditional (more passive) forms of dissemination in the UK.

Ethics approval

East London and The City HA Local Research Ethics Committee 3. Ref 05/Q0605/180

Study design

Cluster randomised control trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Premature babies

Intervention

Of the 181 units recruited, 87 and 94 units were randomised into the active group and the control group, respectively.

The key methods involved in the “Active Dissemination of Information” strategy are:
1. Audit, feedback and benchmarking of units in active arm
2. Active arm lead clinicians participating in workshops with opinion leaders’ lectures on evidence based practice around each outcome and consensus process
3. Implementation of changes at units level with reinforcement by regional leaders trained in organisation of changes

The duration of the intervention was 3 months (October - December 2006).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Outcome measures involve detecting whether there has been a change in any of the following four indicators after the active educational intervention has taken place:
1. Experienced resuscitation team present at birth
2. Surfactant administration in labour ward and timing of intubation
3. Temperature on admission to the neonatal unit and timing of first measurement of temperature
4. Use of plastic bag to prevent heat loss at birth

The four indicators will be measured at baseline and three months after the intervention.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/10/2005

Overall trial end date

01/10/2008

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

181 units , 60 clinicians

Participant exclusion criteria

None

Recruitment start date

01/10/2005

Recruitment end date

01/10/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Confidential Enquiry into Maternal and Child Health
London
NW1 5SD
United Kingdom

Sponsor information

Organisation

The Confidential Enquiry into Maternal and Child Health (UK)

Sponsor details

Chiltern Court
188 Baker Street
London
NW1 5SD
United Kingdom

Sponsor type

Government

Website

http://www.cemach.org.uk

Funders

Funder type

Charity

Funder name

BLISS - The premature baby charity (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/17922901
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21393310

Publication citations

  1. Study protocol

    Acolet D, Jelphs K, Davidson D, Peck E, Clemens F, Houston R, Weindling M, Lavis J, Elbourne D, The BLISS cluster randomised controlled trial of the effect of 'active dissemination of information' on standards of care for premature babies in England (BEADI) study protocol [ISRCTN89683698]., Implement Sci, 2007, 2, 33, doi: 10.1186/1748-5908-2-33.

  2. Results

    Acolet D, Allen E, Houston R, Wilkinson AR, Costeloe K, Elbourne D, Improvement in neonatal intensive care unit care: a cluster randomised controlled trial of active dissemination of information., Arch. Dis. Child. Fetal Neonatal Ed., 2011, 96, 6, F434-9, doi: 10.1136/adc.2010.207522.

Additional files

Editorial Notes