Condition category
Not Applicable
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
30/03/2011
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

Mrs Deborah White

ORCID ID

Contact details

Box No 7
Paediatric Intensive Care Unit
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 217613
deborah.white@addenbrookes.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544139664

Study information

Scientific title

Acronym

Study hypothesis

Approximately 15-20% of so called 'mild' head injured children develop morbidities that necessitate further healthcare interventions. 1000 children are seen in Accident and Emergency (A&E) at Addenbrooke's with 'mild head injury' per year. Our study will be conducted in two parts.

On discharge from the accident and emergency department following a minor head injury, the carers of children are given an information card containing information on expected side effects from the accident. This card is standard care and a requirement following NICE (National Institute of Clinical Excellence) guidelines.

Stage 1: A population-based observational study in order to calculate a sample size for stage 2. Following informed consent, we will contact families 2 weeks following their child's A&E attendance and ask a series of questions around their child's recovery to ascertain how long their child had off school and if the family had to seek further help or advice from the GP or A&E department. This stage of the work will be used as a pilot study and the results obtained will allow us to calculate the sample size needed for stage 2, a randomised controlled trial. The information card will be adapted to include the following name and contact number 'Deborah White, Paediatric Research Nurse - 01223 245151 bleep 151-879'.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Not Applicable: Service delivery

Intervention

Following informed consent, families will be randomised to one of two groups.
The first group will be contacted 1 week following injury to ascertain the progress of the child and offer advice to the family about dealing with the expected symptoms following a head injury.
Both groups 1 and 2 will be contacted 2 weeks following the injury as in stage 1.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The two groups would then be compared to see if the number of visits to A&E or to the GP were any different across the two groups.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

04/03/2003

Overall trial end date

03/03/2007

Reason abandoned

Poor recruitment

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

04/03/2003

Recruitment end date

03/03/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Box No 7
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Cambridge Consortium - Addenbrooke's (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