Extending Midwife/nurse Roles in the routine Examination of the Newborn: randomised controlled evaluation and cost-effectiveness (EMREN trial)

ISRCTN ISRCTN89169926
DOI https://doi.org/10.1186/ISRCTN89169926
Secondary identifying numbers HTA 94/40/05
Submission date
25/04/2003
Registration date
25/04/2003
Last edited
08/11/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Joy Townsend
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific titleExtending Midwife/nurse Roles in the routine Examination of the Newborn: randomised controlled evaluation and cost-effectiveness (EMREN trial)
Study acronymEMREN
Study objectivesThe 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(s)Not provided at time of registration.
Health condition(s) or problem(s) studiedChildbirth
Intervention1. Neonatal examination by trained junior doctors
2. Neonatal examination by trained mid-wives
Intervention typeOther
Primary outcome measureReferrals 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 measuresNot provided at time of registration.
Overall study start date01/03/1999
Completion date31/08/2001

Eligibility

Participant type(s)Patient
Age groupNeonate
SexNot Specified
Target number of participants2000
Key inclusion criteriaNewborn infants
Key exclusion criteriaNot provided at time of registration.
Date of first enrolment01/03/1999
Date of final enrolment31/08/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Public & Environmental Health Research Unit (PEHRU)
London
WC1E 7HT
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
http://www.dh.gov.uk/en/index.htm
ROR logo https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article HTA monograph 01/04/2004 Yes No

Editorial Notes

08/11/2022: Internal review.

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