Premature BabiesPhase 1/2BEADINCT00831168
BEADI - The Bliss Cluster Randomised Control Trial on the Effects of Active Dissemination of Information (BEADI)
A Phase 1/2 study testing Effects of Active Dissemination in people with Premature Babies, run by Confidential Enquiry into Maternal and Child Health.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 27 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Babies
- What is being tested?
- Effects of Active Dissemination
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Mar 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 27 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
None listed.
About this study
Official 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.
- Conditions
- Premature Babies
- Being tested
- Effects of Active Dissemination
- Keywords
- neonatal, premature babies, healthcare research, Babies born before 27 weeks gestation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effects of Active DisseminationBehavioural
No medical intervention involved. It is purely information based.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startOct 2005
- Primary completionMar 2009 (estimated)
- Study completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Confidential Enquiry into Maternal and Child Health
- Sponsor type
- University, hospital or other
- Investigators
- Dominique Acolet, Principal investigator, Confidential Enquiry into Maternal and Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831168
- Sponsor's protocol ID
- BEADI2005
- Acronym
- BEADI
- Status last verified
- Jan 2009
- First submitted
- 27 Jan 2009
- Last updated
- 28 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bliss Cluster Randomised Control Trial on the Effects of Active Dissemination of Information on Outcomes of Premature Babies.
- ClinicalTrials.gov ID
- NCT00831168
- Acronym / sponsor ID
- BEADI / BEADI2005
- Conditions
- Premature Babies
- Keywords
- neonatal, premature babies, healthcare research, Babies born before 27 weeks gestation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Confidential Enquiry into Maternal and Child HealthUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 28 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 22 to 27 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effects of Active DisseminationNo medical intervention involved. It is purely information based. | Behavioural | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Acolet principal investigator
Confidential Enquiry into Maternal and Child Health
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Effects of Active Dissemination in people with Premature Babies, run by Confidential Enquiry into Maternal and Child Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2009.