Randomised double-blind placebo-controlled trial of nasal oxytocin spray in mothers of preterm infants
| ISRCTN | ISRCTN72911449 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72911449 |
| Secondary identifying numbers | N0263115170 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 20/02/2008
- 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
Not provided at time of registration
Contact information
Dr M Fewtrell
Scientific
Scientific
MRC Childhood Nutrition Research Centre
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
| Phone | +44 020 7905 2389 |
|---|---|
| m.fewtrell@ich.ucl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study hypothesis | Does oxytocin nasal spray enable mothers of preterm infants to express more breast milk more easily? |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Pregnancy and Childbirth: Breast feeding |
| Intervention | A. Oxytocin nasal spray B. Placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | oxytocin |
| Primary outcome measure | Total volume of expressed breast milk, proportion of mothers breast feeding their infant. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/08/2002 |
| Overall study end date | 01/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 60 |
| Participant inclusion criteria | 60 Patients from Obstetrics |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 01/08/2002 |
| Recruitment end date | 01/08/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Childhood Nutrition Research Centre
London
WC1N 1EH
United Kingdom
WC1N 1EH
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
University College London Hospitals NHS Trust
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2006 | Yes | No |
