Condition category
Neonatal Diseases
Date applied
02/04/2008
Date assigned
09/06/2008
Last edited
29/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Helen Ball

ORCID ID

Contact details

Department of Anthropology
Durham University
43 Old Elvet
Durham
DH1 3HN
United Kingdom

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 measures

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

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

http://www.newcastle-hospitals.org.uk

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

Results - basic reporting

Publication summary

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21474481

Publication citations

  1. 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.

Additional files

Editorial Notes

29/01/2016: Plain English summary added.