Condition category
Pregnancy and Childbirth
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
27/08/2009
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

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 measures

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

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

http://www.dh.gov.uk/en/index.htm

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

Results - basic reporting

Publication summary

HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/15038906

Publication citations

  1. 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.

Additional files

Editorial Notes