Specialist health visitor intervention for failure to thrive

ISRCTN	ISRCTN81276508
DOI	https://doi.org/10.1186/ISRCTN81276508
Protocol serial number	N/A
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Mary Rudolf
Scientific

Community Paediactrics
Leeds Community and Mental Health Trust
Belmont House
3-5 Belmont Grove
Leeds
LS2 9NP
United Kingdom

Phone	+44 0113 392 6352
Email	mary.rudolf@leedsth.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To determine whether home intervention by a specialist health visitor affects the outcome of children with failure to thrive
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Other nutritional, metabolic and endocrine disease
Intervention	Conventional care vs conventional care plus specialist home visiting for 12 months
Intervention type	Other
Primary outcome measure(s)	1. Growth 2. Eating difficulties 3. Diet 4. Health service utilitilization including hospital admission 5. Maternal mental health
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	28/02/1997

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	42
Key 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
Key exclusion criteria	1. Chronic illness affecting growth 2. Parents non-english speakers
Date of first enrolment	01/04/1994
Date of final enrolment	28/02/1997

Community Paediactrics

Leeds
LS2 9NP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/1999		Yes	No