North-East Cot (NECOT) Trial: Postnatal care and breastfeeding duration

ISRCTN	ISRCTN31466133
DOI	https://doi.org/10.1186/ISRCTN31466133
Protocol serial number	3433
Sponsor	Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Funder	National Institute for Health Research (NIHR), Research for Patient Benefit (RfPB) programme (UK)

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Prof Helen Ball
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised non-blinded trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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(s)	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)
Key secondary outcome measure(s)	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
Completion date	07/01/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

United Kingdom
England

Study participating centre

Durham University

Durham
DH1 3HN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

29/01/2016: Plain English summary added.