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
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