Contact information
Type
Scientific
Primary contact
Prof Joy Townsend
ORCID ID
Contact details
The Public & Environmental Health Research Unit (PEHRU)
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7485 6591/927 2185
joy.townsend@lshtm.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 94/40/05
Study information
Scientific title
Acronym
EMREN
Study hypothesis
The project will evaluate the cost effectiveness of extending midwifery practice in the routine examination of the newborn. The main study is an RCT, with 1000 babies in each arm, of outcome and cost effectiveness of examination by trained junior doctors compared with examination by trained midwives. The value of a further examination at ten days will also be assessed. In depth interviews will be held with paediatricians, midwives, GPs, nurses, patients and Royal Colleges. Effects on the NHS labour market and training needs will be analysed. The research addressed general and specific issues of extending nursing and midwifery roles, concerns regarding junior doctor hours and the timing of examinations of newborn babies, and will inform NHS policy.
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Childbirth
Intervention
1. Neonatal examination by trained junior doctors
2. Neonatal examination by trained mid-wives
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Referrals assessed as appropriate and as major or minor by three independent consultants. Problems identified during the first year of life assessed as identifiable at 24 hours. Quality assessment by video against an agreed written proforma. Maternal satisfaction. Opinion of professionals and mothers about aspects of the examination.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/03/1999
Overall trial end date
31/08/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Newborn infants
Participant type
Patient
Age group
Neonate
Gender
Not Specified
Target number of participants
2000
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/03/1999
Recruitment end date
31/08/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Public & Environmental Health Research Unit (PEHRU)
London
WC1E 7HT
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (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
Basic results (scientific)
Publication list
HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/15038906
Publication citations
-
HTA monograph
Townsend J, Wolke D, Hayes J, Davé S, Rogers C, Bloomfield L, Quist-Therson E, Tomlin M, Messer D, Routine examination of the newborn: the EMREN study. Evaluation of an extension of the midwife role including a randomised controlled trial of appropriately trained midwives and paediatric senior house officers., Health Technol Assess, 2004, 8, 14, iii-iv, ix-xi, 1-100.