Condition category
Neonatal Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
09/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr RC Coombs

ORCID ID

Contact details

Sheffield Teaching Hospital
Western Bank
Sheffield
S10 2TH
United Kingdom
+44 (0)114 2268387

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes