Allergen avoidance in infancy and development of asthma and allergy during childhood: a randomised controlled trial. Follow-up at the age of 8 yrs
| ISRCTN | ISRCTN64243404 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64243404 |
| Secondary identifying numbers | SPGS788 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 08/02/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S H Arshad
Scientific
Scientific
Asthma and Allergy Research Centre
St Mary's Hospital
Isle of Wight
Newport
PO30 5TG
United Kingdom
| Phone | +44 (0)1983 822928 |
|---|---|
| sha@soton.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet. |
| Scientific title | |
| Study objectives | In infants genetically predisposed to atopy, allergen exposure in infancy plays a critical role in the development of phenotypic manifestations. Allergen avoidance in this period leads to a reduction in the prevalence of asthma, other allergic disorders and/or skin sensitisation. |
| Ethics approval(s) | Added 08/02/10: The Isle of Wight Local Research Ethics Committee approved on the 23rd of December 1997 (ref: 35/97) |
| Health condition(s) or problem(s) studied | Asthma |
| Intervention | Reduced allergen exposure (food and aero-allergen) in prophylactic group |
| Intervention type | Other |
| Primary outcome measure | 1. Two questionnaires to assess symptoms suggestive of allergic diseases 2. Physical examination 3. Skin prick tests 4. Pulmonary function tests and bronchial challenges 5. Total serum IgE 6. Aero-allergen screen |
| Secondary outcome measures | None |
| Overall study start date | 01/05/1998 |
| Completion date | 01/05/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 8 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 120 infants with high risk of atopy recruited antenatally, now aged 8 yrs |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/05/1998 |
| Date of final enrolment | 01/05/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Asthma and Allergy Research Centre
Newport
PO30 5TG
United Kingdom
PO30 5TG
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive South East (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2003 | Yes | No | |
| Results article | results | 01/02/2007 | Yes | No |
