Infants’ immunizations, their timing and the risk of allergic diseases (INITIAL) – an observational prospective cohort study

Recruiting

Conditions: J45.0
J30.1
L20
T78
Predominantly allergic asthma
Allergic rhinitis due to pollen
Atopic dermatitis
Adverse effects, not elsewhere classified

Registration Number: DRKS00029677

Lead Sponsor: Gerhard-Kienle-Lehrstuhl, Fakultät für Gesundheit, Private Universität Witten/Herdecke gGmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 4500

Inclusion Criteria

Parents of children four to five weeks of age (U3).
- Signed informed consent regarding electronic transmission of medical information for research purposes.
- Reading, writing and understanding the German language

Exclusion Criteria

- Families already participating in the study with a child.
- Missing digital device with Internet access or a contact email address.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following five primary endpoints are equal at five years of age (U9) and are assessed by physician-confirmed parental statements (repeating questionnaires) of lifetime prevalence:<br>(a.) any atopy (asthma, hay fever, atopic dermatitis, food allergy).<br>b.) asthma <br>c.) hay fever<br>d.) eczema = atopic dermatitis<br>e.) food allergy

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures are descriptive and exploratory. They include <br>- Other atopy such as contact dermatitis, and other allergens, (e.g. house dust or animal hair).<br>- Other measuring points at one year of age (U6) and three years of age (U7a).<br>- Intensity of advice is analyzed individually and aggregated in the form of an a priori defined sum score weighted by the following aspects:<br>- Self-informed whether book or internet (2), <br>- information provided by the physician during the preventive care (2), <br>- during the vaccination appointment (1) <br>- or as a separate appointment (3) <br>- and no consultation at all (0). <br>- Information transfer desired and received is exploratory.<br>