Overview

This trial is active, not recruiting.

Condition premature babies
Treatment effects of active dissemination
Phase phase 1/phase 2
Sponsor Confidential Enquiry into Maternal and Child Health
Start date October 2005
End date March 2009
Trial size 200 participants
Trial identifier NCT00831168, BEADI2005

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose health services research

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 22 weeks up to 27 weeks old.

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

Additional Information

Official title The Bliss Cluster Randomised Control Trial on the Effects of Active Dissemination of Information on Outcomes of Premature Babies.
Principal investigator Dominique Acolet
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by Confidential Enquiry into Maternal and Child Health.