Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0220111014
Study information
Scientific title
Acronym
Study hypothesis
Can parents safely and routinely use Baby Check (a parent administered infant illness severity score) and that they will seek professional medical attention for their infant more appropriately than parents without Baby Check? These hypotheses will be examined specifically in relation, accuracy of diary use and appropriateness of visits to the GP and hospital admissions.
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
Other
Trial type
Diagnostic
Patient information sheet
Condition
Neonatal Diseases
Intervention
This pilot study is confined to the residents of the South and South West PCTs in Sheffield. The participating Health Visitors will recruit Primips at 36 weeks at their routine ante natal visit. They will be enrolled by the Health Visitor 1-14 days postnatally. The CONI office (in Sheffield) will randomise families and send the appropriate symptom diary (and thermometer if randomised to Baby Check arm) to the family home enabling the Health Visitor to familiarise the family with the use of the symptom diary (and Baby Check) at this first post natal visit.
GPs will be informed and sent appropriateness of consultation forms at the time of the infants' enrolment.
The symptom diaries will be kept by the parents for a period of 3 months during which we would expect from routine health care there would be around six contacts with either the Health Visitor or the GP. Once completed the diaries will be returned to the CONI office for analysis prior to being returned to the parents or being destroyed.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The proposed pilot study to be undertaken in Sheffield is to test whether parents can use and complete the revised diary; whether when used in conjunction with Baby Check it influences the use of medical services (GP and hospital); whether following consultation with the GP the parents are more empowered and the GP perceives the consultation to be appropriate.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2002
Overall trial end date
30/09/2004
Reason abandoned
Eligibility
Participant inclusion criteria
This pilot study is confined to the residents of the South and South West PCTs in Sheffield. The participating Health Visitors will recruit Primips at 36 weeks at their routine ante natal visit. They will be enrolled by the Health Visitor 1-14 days postnatally. For the pilot scheme only families with English as their first language will be recruited. We will recruit 120 families, randomised to 60 study infants and 60 controls.
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
120 (60 study infants and 60 controls)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/06/2002
Recruitment end date
30/09/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Sheffield Teaching Hospital
Sheffield
S10 2TH
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Sheffield Childrens Hospital NHS Trust (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