Premature Babies Clinical Trial
— BEADIOfficial title:
The Bliss Cluster Randomised Control Trial on the Effects of Active Dissemination of Information on Outcomes of Premature Babies.
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.
| Status | Active, not recruiting |
| Enrollment | 200 |
| Est. completion date | March 2009 |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 22 Weeks to 27 Weeks |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Confidential Enquiry into Maternal and Child Health |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 3 years | No |