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ISRCTN
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ISRCTN31466133
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ClinicalTrials.gov identifier
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Public title
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North-East Cot (NECOT) Trial: Postnatal care and breastfeeding duration
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Scientific title
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Acronym
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NECOT
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Serial number at source
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3433
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Study hypothesis
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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).
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Ethics approval
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County Durham and Tees Valley 2 Research Ethics Committee. Date of approval: 22/08/2007 (ref: 07/H0908/57)
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Study design
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Randomised non-blinded trial.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Postnatal care
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Participants - inclusion criteria
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1. Women with normal singleton pregnancies
2. Prenatal intention to breastfeed
3. Informed consent
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Participants - exclusion criteria
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1. Multiple pregnancies
2. Foetal anomalies
3. Ill mother or baby following delivery
4. No prenatal intention to breastfeed
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Anticipated start date
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07/01/2008
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Anticipated end date
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07/01/2010
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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800
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Interventions
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Side-car crib vs stand alone bassinette
Duration of intervention: For the duration of the postnatal ward stay (typically 24 hours)
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Primary outcome measure(s)
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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)
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Secondary outcome measure(s)
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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
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Sources of funding
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National Institute for Health Research (NIHR), Research for Patient Benefit (RfPB) programme (UK)
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Trial website
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Publications
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Contact name
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Prof
Helen
Ball
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Address
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Department of Anthropology
Durham University
43 Old Elvet
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City/town
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Durham
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Zip/Postcode
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DH1 3HN
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Country
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United Kingdom
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Sponsor
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Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
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Address
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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
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City/town
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Newcastle-upon-Tyne
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Zip/Postcode
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NE1 4LP
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Country
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United Kingdom
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Sponsor website:
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http://www.newcastle-hospitals.org.uk
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Date applied
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02/04/2008
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Last edited
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09/06/2008
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Date ISRCTN assigned
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09/06/2008
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