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 |
| Protocol serial number | HTA 94/40/05 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
Scientific
The Public & Environmental Health Research Unit (PEHRU)
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
| Phone | +44 (0)20 7485 6591/927 2185 |
|---|---|
| joy.townsend@lshtm.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Extending Midwife/nurse Roles in the routine Examination of the Newborn: randomised controlled evaluation and cost-effectiveness (EMREN trial) |
| Study acronym | EMREN |
| Study objectives | 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(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Childbirth |
| Intervention | 1. Neonatal examination by trained junior doctors 2. Neonatal examination by trained mid-wives |
| Intervention type | Other |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 31/08/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target sample size at registration | 2000 |
| Key inclusion criteria | Newborn infants |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/03/1999 |
| Date of final enrolment | 31/08/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The Public & Environmental Health Research Unit (PEHRU)
London
WC1E 7HT
United Kingdom
WC1E 7HT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not 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.
