Condition category
Pregnancy and Childbirth
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
20/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M Fewtrell

ORCID ID

Contact details

MRC Childhood Nutrition Research Centre
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 020 7905 2389
m.fewtrell@ich.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0263115170

Study information

Scientific title

Acronym

Study hypothesis

Does oxytocin nasal spray enable mothers of preterm infants to express more breast milk more easily?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Pregnancy and Childbirth: Breast feeding

Intervention

A. Oxytocin nasal spray
B. Placebo

Intervention type

Drug

Phase

Not Specified

Drug names

oxytocin

Primary outcome measures

Total volume of expressed breast milk, proportion of mothers breast feeding their infant.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2002

Overall trial end date

01/08/2006

Reason abandoned

Eligibility

Participant inclusion criteria

60 Patients from Obstetrics

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/08/2002

Recruitment end date

01/08/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Childhood Nutrition Research Centre
London
WC1N 1EH
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

University College London Hospitals NHS Trust

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 on http://www.ncbi.nlm.nih.gov/pubmed/16223754

Publication citations

  1. Results

    Fewtrell MS, Loh KL, Blake A, Ridout DA, Hawdon J, Randomised, double blind trial of oxytocin nasal spray in mothers expressing breast milk for preterm infants., Arch. Dis. Child. Fetal Neonatal Ed., 2006, 91, 3, F169-74, doi: 10.1136/adc.2005.081265.

Additional files

Editorial Notes