Contact information
Type
Scientific
Primary contact
Dr Helen Ball
ORCID ID
Contact details
Department of Anthropology
Durham University
43 Old Elvet
Durham
DH1 3HN
United Kingdom
+44 (0)191 3340260
h.l.ball@dur.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
02277
Study information
Scientific title
Acronym
Study hypothesis
That mother-infant sleep proximity on the first two nights of life affects the success of breastfeeding initiation
Ethics approval
Approval received 27/09/2002 reference 2002/272
Study design
Randomised non-blinded intervention
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Breastfeeding initiation
Intervention
Control: baby in stand alone cot (rooming in)
Intervention 1 = baby in mother's bed
Intervention 2 = baby in side car crib
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Successful initiation of breastfeeding, defined on the basis of the observed infant behaviours (attempted feeds, successful feeds, feeding effort)
Secondary outcome measures
Infant safety, determined by assessing potential risk exposure: frequency per hour and proportional duration of potentially adverse situations categorised as:
1. Breathing risk (external airways covered)
2. Overheating risk (head completely covered)
3. Falling risk (positioned precariously)
4. Entrapment risk (wedged between bed and side-rail)
5. Overlaying risk (trapped under mothers torso)
Overall trial start date
01/10/2002
Overall trial end date
31/03/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy, non-smoking women, pregnant with a single infant, anticipating a normal vaginal delivery and intending to breast feed
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
90
Participant exclusion criteria
Post-partum exclusion criteria: caesarean delivery, ill baby or mother and receipt of intravenous or intramuscular opiate analgesics in the preceding 24 hours
Recruitment start date
01/10/2002
Recruitment end date
31/03/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anthropology
Durham
DH1 3HN
United Kingdom
Sponsor information
Organisation
Newcastle Upon Tyne Hospitals NHS Trust (UK)
Sponsor details
Research and Development Department
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
+44 (0)1912 336161
trust.rand@nuth.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Project grant from Babes in Arms (10/08/2002) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16849364
Publication citations
-
Results
Ball HL, Ward-Platt MP, Heslop E, Leech SJ, Brown KA, Randomised trial of infant sleep location on the postnatal ward., Arch. Dis. Child., 2006, 91, 12, 1005-1010, doi: 10.1136/adc.2006.099416.