Condition category
Pregnancy and Childbirth
Date applied
29/12/2005
Date assigned
24/01/2006
Last edited
27/01/2010
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 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 mother’s 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

  1. 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.

Additional files

Editorial Notes