Clinical trial

Preventing Atopic Dermatitis and ALLergies in Children

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT02449850

Active, not recruitingNot applicableInterventional

What this study is about

The primary objective is of the PreventADALL study is to test if primary prevention of allergic diseases is possible by simple and low cost strategies, and secondary to asses the impact of xenobiotic exposure and microbiota in and on the body and the environment on allergic disease development. The secondary objective is an exploratory focus to investigate early life risk factors for development of non-communicable diseases, including asthma and allergic diseases as well as for diseases that may share common risk factors, including cardiovascular disease, obesity and diabetes. Design: A multi-national population-based prospective birth cohort with a factorial designed randomized controlled intervention trial of two clinical interventions; skin care 0-9 months and early food introduction by 3-4 months, thereafter observation only. Recruitment in three cities (Oslo, Ostfold and Stockholm) of approximately 2500 mother-child pairs is done in two steps; first pregnant women are recruited and enrolled at the 18-weeks ultrasound investigation (n=approximately 2700) and thereafter their new-born babies are included. Randomization into four groups is done by the postal code or "township" to ensure all four intervention-groups within each "township". Visits for biological and environmental sampling, observations and investigations will be at the relevant pediatric departments (at 3-6-12-24-36 months of age) and through childhood into adulthood thereafter, provided sufficient funding.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

AgeNot listed to Not listed

SexAll

Healthy volunteersAccepted

ConditionAtopic Dermatitis, Food Allergy in Children, Asthma, Rhinitis, Allergic, Non-communicable Diseases, Obesity, Cardiovascular Disease

Full registry criteria

The study enrolls Mother-child pairs in two steps; first mother, thereafter her new-born baby. Inclusion Criteria: 1\. Ante-natal inclusion, step 1: All mothers to-be at 18 weeks ultrasound investigation with sufficient language skills (Norwegian or Swedish), gestational age: at least 16-22 weeks. 1\. Exclusion: Plans to move further than reasonable travel distance from any of the participating hospitals within the first year of the offspring's life. 1\. Inclusion of the child, step 2: Live-born babies of gestational age 35.0 weeks or more (including multiple pregnancies), maternal/parental willingness to participate in the study Exclusion Criteria: Exclusion criteria child: 1) severe neonatal cardiac, pulmonary, neurologic, dermatologic disease or other disease that may influence the outcomes 2), plans to move further than reasonable travel distance away from any of the participating hospitals within the first nine months of life. 3\) Non-willingness to participate, 4) More than two foetuses

Treatments and study arms

Food intervention

Other

Intervention; systematic introduction of egg, milk, wheat and peanut by 4 months of age

Skin care

Other

Bath with bath-oil aim and Ceridal face cream for least 5 times/ week from 0.5-9 months of age.

Primary outcomes

Atopic dermatitis (AD)AD 0-12 months, with follow-up investigations at 2 and 3 yrs and at intervals up to year 2044, provided funding

AD by international standards,

Food allergy to any intervention allergen0-36 months, assessed first at 36 months, with follow-up investigations at intervals up to year 2044, provided funding

By clinical relevant reactions, intolerance to foods and food challenges, when needed

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Oslo University Hospital and University of Oslo🇳🇴 Oslo, Norway

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