North-East Cot (NECOT) Trial: Postnatal care and breastfeeding duration
| ISRCTN | ISRCTN31466133 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31466133 |
| Secondary identifying numbers | 3433 |
- Submission date
- 02/04/2008
- Registration date
- 09/06/2008
- Last edited
- 29/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Plain English summary of protocol
Background and study aims
It is well known that close contact between mums and babies at night makes it easier to establish breastfeeding, and to continue breastfeeding for longer. Close contact allows the baby to suckle more frequently, which helps with initiation of breastfeeding, and also with establishing a good long-term milk supply. While we know that close contact is good for breastfeeding, some people have concerns about mums and babies sharing a bed, especially in the immediate postnatal period when mums may have had pain relief potentially affecting their awareness of the baby. Our previous research demonstrated that using a side-car crib instead of a stand-alone bassinette resulted in mums and babies interacting in the same way as if they were sharing the same bed. They also breastfed for significantly longer – more than twice as many ‘side-car’ mums than ‘standalone crib’ mums were still breastfeeding at 16 weeks. We wanted to find out if we would still obtain this result when the side-car cribs were used on a much larger scale.
Who can participate?
Women who intend to breastfeed their baby in the postnatal ward
What does the study involve?
Participants are randomly assigned to receive either the side-car or standalone crib, and are asked to report on their infant’s feeding and sleeping until their baby is 6 months old.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Royal Victoria Infirmary (UK)
When is the study starting and how long is it expected to run for?
January 2008 to January 2010
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Prof Helen Ball
Contact information
Scientific
Department of Anthropology
Durham University
43 Old Elvet
Durham
DH1 3HN
United Kingdom
Study information
| Study design | Randomised non-blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Patient information can be found at: http://www.dur.ac.uk/sleep.lab/necot/ |
| Scientific title | North-East Cot (NECOT) Trial: Postnatal care and breastfeeding duration |
| Study acronym | NECOT |
| Study objectives | Trial aims to address whether infant proximity to mother on postnatal ward affects long-term breastfeeding outcomes (to be assessed by use of two cot types). |
| Ethics approval(s) | County Durham and Tees Valley 2 Research Ethics Committee, 22/08/2007, ref: 07/H0908/57 |
| Health condition(s) or problem(s) studied | Postnatal care |
| Intervention | Side-car crib vs stand alone bassinette Duration of intervention: For the duration of the postnatal ward stay (typically 24 hours) |
| Intervention type | Other |
| Primary outcome measure | 1. Time to cessation of exclusive breast-feeding (baby receiving any food item other than breastmilk in preceding week) 2. Time to cessation of any breast feeding (baby receiving no breastmilk for at least 2 consecutive weeks) |
| Secondary outcome measures | 1. Percentage of weeks in which any bed-sharing is reported (presence/absence of bed-sharing in preceding week). Participants will provide weekly data regarding this variable for 6 months. The outcome will be assessed at end of 6 month follow-up period. 2. Percentage of weeks in which infant illness is reported (presence/absence of contact with health professional due to concern for infant health in preceding week). Participants will provide weekly data regarding this variable for 6 months. The outcome will be assessed at end of 6 month follow-up period. 3. Duration of post-natal ward stay 4. Prenatal propensity to breastfeed (likert scale), data obtained at enrolment 5. Prenatal attitude to breastfeeding (likert scale), data obtained at enrolment |
| Overall study start date | 07/01/2008 |
| Completion date | 07/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 800 |
| Key inclusion criteria | 1. Women with normal singleton pregnancies 2. Prenatal intention to breastfeed 3. Informed consent |
| Key exclusion criteria | 1. Multiple pregnancies 2. Foetal anomalies 3. Ill mother or baby following delivery 4. No prenatal intention to breastfeed |
| Date of first enrolment | 07/01/2008 |
| Date of final enrolment | 07/01/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
DH1 3HN
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Dr Lesley Hall
Research Governance Manager
Newcastle upon Tyne Hospitals NHS Foundation Trust
R&D Department
4th Floor
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle-upon-Tyne
NE1 4LP
England
United Kingdom
| Website | http://www.newcastle-hospitals.org.uk |
|---|---|
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
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 | 01/07/2011 | Yes | No |
Editorial Notes
29/01/2016: Plain English summary added.
