Condition category
Neonatal Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
12/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Neal

ORCID ID

Contact details

Honor Oak Health Centre
20 Turnham Rd
Brokley
London
SE4 1JN
United Kingdom
+44

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0125146731

Study information

Scientific title

Acronym

Study hypothesis

1. Does use of a soft baby carrier promote mother-infant sensitivity?
2. Does soft baby carrier use promote secure infant attachment in children from a variety of family backgrounds who would otherwise be at high risk of developing an insecure attachment?

As of June 2008: trial has not started.

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

Neonatal Diseases

Intervention

1. Experimental: Provision of soft baby carrier(s) appropriate for infant carriage against the trunk for the first six months after birth, with ongoing encouragement to use for 2 hours daily.
2. Control: Provision of infant clothing vouchers.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. The means of measures of 3 axes of maternal care - the Care Index (Crittenden, 1992) at 3 months.
2. The proportions of experimental and control groups with secure attachment - Strange Situation Test at 13 months (Ainsworth, 1978).
3. Actual duration and intensity of soft baby carrier use at 1, 3, 5, 8 and 13 months.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2005

Overall trial end date

30/09/2007

Reason abandoned

Not started, awaiting approval/ funding

Eligibility

Participant inclusion criteria

Mothers of newborns that are eligible and give informed consent will be randomly assigned to the experimental or the control group, based on revealing the next in a series of random numbers.
Women who deliver a singleton live infant in the delivery suite of a large, inner-city hospital, aged 16+, accessible by telephone, able to speak conversational English, and not planning to move out of the area within 15 months will be eligible for participation in the study.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2005

Recruitment end date

30/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Honor Oak Health Centre
London
SE4 1JN
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Lewisham Research Unit (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

Publication citations

Additional files

Editorial Notes