Does Baby Check improve parental recognition of the severity of their child's illness: a pilot study of the revised Baby Check Symptom Diary
| ISRCTN | ISRCTN15787254 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15787254 |
| Secondary identifying numbers | N0220111014 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 09/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr RC Coombs
Scientific
Scientific
Sheffield Teaching Hospital
Western Bank
Sheffield
S10 2TH
United Kingdom
| Phone | +44 (0)114 2268387 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Diagnostic |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/06/2002 |
| Completion date | 30/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 120 (60 study infants and 60 controls) |
| Key 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. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 30/09/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Sheffield Teaching Hospital
Sheffield
S10 2TH
United Kingdom
S10 2TH
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Sheffield Childrens Hospital NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
