The effect of early nutrition in high-risk infants on allergy prevention during the first 12 months of life. Extension: The effect of nutrition given in the first 6 months of life in high-risk infants on allergy prevention up to 7 years of age.

The effect early nutrition in high-risk infants on allergy prevention during the first 12 months of life. Extension: The effect of nutrition given in the first 6 months of life in high-risk infants on allergy prevention up to 7 years of age.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26735

Enrollment

1200

Registered

2005-12-13

Start date

2006-01-31

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infants with a high risk classification for atopic disease

Interventions

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

Eligibility

Inclusion criteria

Inclusion criteria: Main criteria: New born infants, high risk classification for atopic disease (at least one of the parents with documented allergic disease). Extension: 1. Participation in and completion of the PATCH-study; 2. Written informed consent; 3. Aged between 2 (- 4 weeks) and 3 years (+ 4 weeks).

Exclusion criteria

Exclusion criteria: Main criteria: Premature delivery, twins, neonatal illnessess, significant congenital abnormalities, intake of cow's milk based formula before randomisation. Extension: Investigator's uncertainty about the willingness or ability of the child and parents to comply with the protocol requirements.

Design outcomes

Primary

Measure	Time frame
Main study: Cumulative incidence of AEDS. Diagnosis according to modified Hanifin and Rajka criteria and SCORAD index of 10 or higher. Extension: Cumulative incidence of allergic manifestations (atopic dermatitis, food allergy, allergic rhinitis, allergic conjunctivitis, allergic urticaria and allergic asthma) based on physician’s diagnosis.	—

Secondary

Measure	Time frame
Main study: 1. Severity and course of AEDS; 2. Gastro- intestinal tract characteristics; 3. Faecal microbiota; 4. Immunological blood parameters. Extension: 1. Period prevalence of allergic manifestations; 2. Severity of allergic manifestation; 3. Lung function 4. Markers of intestinal health; 5. Blood samples for immunological parameters.	—

Contacts

Public ContactDineke Klaassen

Numico Research B.V. P.O. Box 7005

Dineke.Klaassen@numico-research.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)