Bedding-in on the post-natal ward

ISRCTN	ISRCTN03365778
DOI	https://doi.org/10.1186/ISRCTN03365778
Protocol serial number	02277
Sponsor	Newcastle Upon Tyne Hospitals NHS Trust (UK)
Funder	Project grant from Babes in Arms (10/08/2002) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Helen Ball
Scientific

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

Phone	+44 (0)191 3340260
Email	h.l.ball@dur.ac.uk

Primary study design	Interventional
Study design	Randomised non-blinded intervention
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	That mother-infant sleep proximity on the first two nights of life affects the success of breastfeeding initiation
Ethics approval(s)	Approval received 27/09/2002 reference 2002/272
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Successful initiation of breastfeeding, defined on the basis of the observed infant behaviours (attempted feeds, successful feeds, feeding effort)
Key secondary outcome measure(s)	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)
Completion date	31/03/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	90
Key inclusion criteria	Healthy, non-smoking women, pregnant with a single infant, anticipating a normal vaginal delivery and intending to breast feed
Key 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
Date of first enrolment	01/10/2002
Date of final enrolment	31/03/2005

Department of Anthropology

Durham
DH1 3HN
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2006		Yes	No