Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
3433
Study information
Scientific title
North-East Cot (NECOT) Trial: Postnatal care and breastfeeding duration
Acronym
NECOT
Study hypothesis
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
County Durham and Tees Valley 2 Research Ethics Committee, 22/08/2007, ref: 07/H0908/57
Study design
Randomised non-blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Patient information can be found at: http://www.dur.ac.uk/sleep.lab/necot/
Condition
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
Phase
Not Specified
Drug names
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 trial start date
07/01/2008
Overall trial end date
07/01/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women with normal singleton pregnancies
2. Prenatal intention to breastfeed
3. Informed consent
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
800
Participant exclusion criteria
1. Multiple pregnancies
2. Foetal anomalies
3. Ill mother or baby following delivery
4. No prenatal intention to breastfeed
Recruitment start date
07/01/2008
Recruitment end date
07/01/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Durham University
Durham
DH1 3HN
United Kingdom
Sponsor information
Organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Sponsor details
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
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR), Research for Patient Benefit (RfPB) programme (UK)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21474481
Publication citations
-
Results
Ball HL, Ward-Platt MP, Howel D, Russell C, Randomised trial of sidecar crib use on breastfeeding duration (NECOT)., Arch. Dis. Child., 2011, 96, 7, 630-634, doi: 10.1136/adc.2010.205344.