Randomised double-blind placebo-controlled trial of nasal oxytocin spray in mothers of preterm infants

ISRCTN	ISRCTN72911449
DOI	https://doi.org/10.1186/ISRCTN72911449
Protocol serial number	N0263115170
Sponsor	Department of Health (UK)
Funder	University College London Hospitals NHS Trust

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr M Fewtrell
Scientific

MRC Childhood Nutrition Research Centre
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom

Phone	+44 020 7905 2389
Email	m.fewtrell@ich.ucl.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Does oxytocin nasal spray enable mothers of preterm infants to express more breast milk more easily?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Pregnancy and Childbirth: Breast feeding
Intervention	A. Oxytocin nasal spray B. Placebo
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	oxytocin
Primary outcome measure(s)	Total volume of expressed breast milk, proportion of mothers breast feeding their infant.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/08/2006

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	60
Key inclusion criteria	60 Patients from Obstetrics
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/08/2002
Date of final enrolment	01/08/2006

MRC Childhood Nutrition Research Centre

London
WC1N 1EH
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	01/05/2006		Yes	No