Bedding-in on the post-natal ward
| ISRCTN | ISRCTN03365778 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03365778 |
| Secondary identifying numbers | 02277 |
- Submission date
- 29/12/2005
- Registration date
- 24/01/2006
- Last edited
- 27/01/2010
- 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
Dr Helen Ball
Scientific
Scientific
Department of Anthropology
Durham University
43 Old Elvet
Durham
DH1 3HN
United Kingdom
| Phone | +44 (0)191 3340260 |
|---|---|
| h.l.ball@dur.ac.uk |
Study information
| Study design | Randomised non-blinded intervention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | |
| Study objectives | That mother-infant sleep proximity on the first two nights of life affects the success of breastfeeding initiation |
| Ethics approval(s) | Approval received 27/09/2002 reference 2002/272 |
| Health condition(s) or problem(s) studied | Breastfeeding initiation |
| Intervention | Control: baby in stand alone cot (rooming in) Intervention 1 = baby in mother's bed Intervention 2 = baby in side car crib |
| Intervention type | Other |
| Primary outcome measure | Successful initiation of breastfeeding, defined on the basis of the observed infant behaviours (attempted feeds, successful feeds, feeding effort) |
| Secondary outcome measures | Infant safety, determined by assessing potential risk exposure: frequency per hour and proportional duration of potentially adverse situations categorised as: 1. Breathing risk (external airways covered) 2. Overheating risk (head completely covered) 3. Falling risk (positioned precariously) 4. Entrapment risk (wedged between bed and side-rail) 5. Overlaying risk (trapped under mothers torso) |
| Overall study start date | 01/10/2002 |
| Completion date | 31/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 90 |
| Key inclusion criteria | Healthy, non-smoking women, pregnant with a single infant, anticipating a normal vaginal delivery and intending to breast feed |
| Key exclusion criteria | Post-partum exclusion criteria: caesarean delivery, ill baby or mother and receipt of intravenous or intramuscular opiate analgesics in the preceding 24 hours |
| Date of first enrolment | 01/10/2002 |
| Date of final enrolment | 31/03/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Anthropology
Durham
DH1 3HN
United Kingdom
DH1 3HN
United Kingdom
Sponsor information
Newcastle Upon Tyne Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Department
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
England
United Kingdom
| Phone | +44 (0)1912 336161 |
|---|---|
| trust.rand@nuth.nhs.uk | |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Charity
Project grant from Babes in Arms (10/08/2002) (UK)
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 | 01/12/2006 | Yes | No |
