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
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

Study designRandomised non-blinded trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Patient information can be found at: http://www.dur.ac.uk/sleep.lab/necot/
Scientific titleNorth-East Cot (NECOT) Trial: Postnatal care and breastfeeding duration
Study acronymNECOT
Study objectivesTrial 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) studiedPostnatal care
InterventionSide-car crib vs stand alone bassinette

Duration of intervention: For the duration of the postnatal ward stay (typically 24 hours)
Intervention typeOther
Primary outcome measure1. 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 measures1. 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 date07/01/2008
Completion date07/01/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants800
Key inclusion criteria1. Women with normal singleton pregnancies
2. Prenatal intention to breastfeed
3. Informed consent
Key exclusion criteria1. Multiple pregnancies
2. Foetal anomalies
3. Ill mother or baby following delivery
4. No prenatal intention to breastfeed
Date of first enrolment07/01/2008
Date of final enrolment07/01/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Durham University
Durham
DH1 3HN
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
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 logo "ROR" https://ror.org/05p40t847

Funders

Funder type

Government

National Institute for Health Research (NIHR), Research for Patient Benefit (RfPB) programme (UK)
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.