Contact information
Type
Scientific
Primary contact
Dr Mary Rudolf
ORCID ID
Contact details
Community Paediactrics
Leeds Community and Mental Health Trust
Belmont House
3-5 Belmont Grove
Leeds
LS2 9NP
United Kingdom
+44 0113 392 6352
mary.rudolf@leedsth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
To determine whether home intervention by a specialist health visitor affects the outcome of children with failure to thrive
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
Treatment
Patient information sheet
Condition
Other nutritional, metabolic and endocrine disease
Intervention
Conventional care vs conventional care plus specialist home visiting for 12 months
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Growth
2. Eating difficulties
3. Diet
4. Health service utilitilization including hospital admission
5. Maternal mental health
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/1994
Overall trial end date
28/02/1997
Reason abandoned
Eligibility
Participant inclusion criteria
Children referred to a failure to thrive clinic - aged 4-30 months and weight below third centile, or deceleration in weight gain over two centile channels
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
42 (added 17/09/09)
Participant exclusion criteria
1. Chronic illness affecting growth
2. Parents non-english speakers
Recruitment start date
01/04/1994
Recruitment end date
28/02/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Community Paediactrics
Leeds
LS2 9NP
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (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
1999 results in http://www.ncbi.nlm.nih.gov/pubmed/10331996
Publication citations
-
Results
Raynor P, Rudolf MC, Cooper K, Marchant P, Cottrell D, A randomised controlled trial of specialist health visitor intervention for failure to thrive., Arch. Dis. Child., 1999, 80, 6, 500-506.