The effect of early nutrition in high-risk infants on allergy prevention during the first 12 months of life
| ISRCTN | ISRCTN65195597 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65195597 |
| Protocol serial number | N/A |
| Sponsor | Numico Research BV (Netherlands) |
| Funder | Numico Research BV (Netherlands) |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 04/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Dineke Klaassen
Scientific
Scientific
Numico Research B.V.
P.O. Box 7005
Wageningen
6700 CA
Netherlands
| Dineke.Klaassen@numico-research.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised double-blind active-controlled parallel-group trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The effect of early nutrition in high-risk infants on allergy prevention during the first 12 months of life |
| Study acronym | PATCH |
| Study objectives | It is expected that feeding a new hypoallergenic formula will result in a lower occurrence of Atopic Eczema Dermatitis Syndrome (AEDS) compared to giving a standard formula in infants with a high risk of developing atopic disease. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Atopic disease |
| Intervention | Nutritional intervention starting between the age of 0 to 28 days after birth with formula feeding until the age of 26 weeks in a double-blind, randomised, parallel manner. The study will also include a group of exclusively breastfed infants. |
| Intervention type | Other |
| Primary outcome measure(s) |
Cumulative incidence of AEDS. Diagnosis according to modified Hanifin and Rajka criteria and SCORAD index of 10 or higher. |
| Key secondary outcome measure(s) |
1. Severity and course of AEDS |
| Completion date | 31/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 1200 |
| Key inclusion criteria | 1. Newborn infants 2. High risk classification for atopic disease (at lease one of the parents with documented allergic disease) |
| Key exclusion criteria | 1. Premature delivery 2. Twins 3. Neonatal illnesses 4. Significant congenital abnormalities 5. Intake of cow's milk based formula before randomisation |
| Date of first enrolment | 31/01/2006 |
| Date of final enrolment | 31/07/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Numico Research B.V.
Wageningen
6700 CA
Netherlands
6700 CA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/05/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
04/05/2016: Publication reference added.
