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
Secondary identifying numbers N/A
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

Not provided at time of registration

Contact information

Ms Dineke Klaassen
Scientific

Numico Research B.V.
P.O. Box 7005
Wageningen
6700 CA
Netherlands

Dineke.Klaassen@numico-research.nl

Study information

Study designMulticentre randomised double-blind active-controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe effect of early nutrition in high-risk infants on allergy prevention during the first 12 months of life
Study acronymPATCH
Study hypothesisIt 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
ConditionAtopic disease
InterventionNutritional 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 typeOther
Primary outcome measureCumulative incidence of AEDS. Diagnosis according to modified Hanifin and Rajka criteria and SCORAD index of 10 or higher.
Secondary outcome measures1. Severity and course of AEDS
2. Gastro-intestinal tract characteristics
3. Faecal microbiota
4. Immunological blood parameters
Overall study start date31/01/2006
Overall study end date31/07/2008

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants1200
Participant inclusion criteria1. Newborn infants
2. High risk classification for atopic disease (at lease one of the parents with documented allergic disease)
Participant exclusion criteria1. Premature delivery
2. Twins
3. Neonatal illnesses
4. Significant congenital abnormalities
5. Intake of cow's milk based formula before randomisation
Recruitment start date31/01/2006
Recruitment end date31/07/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Numico Research B.V.
Wageningen
6700 CA
Netherlands

Sponsor information

Numico Research BV (Netherlands)
Industry

PO Box 7005
Wageningen
6700 CA
Netherlands

ROR logo https://ror.org/00aj77a24

Funders

Funder type

Industry

Numico Research BV (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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

Editorial Notes

04/05/2016: Publication reference added.

Springer Nature