Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
17/09/2009
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 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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes