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Preventing Atopic Dermatitis and ALLergies in Children (PreventADALL)

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ClinicalTrials.gov Identifier: NCT02449850
Recruitment Status : Active, not recruiting
First Posted : May 20, 2015
Last Update Posted : October 2, 2017
Sponsor:
Collaborators:
University of Oslo
Karolinska Institutet
Helsinki University Central Hospital
University of Lausanne Hospitals
Norwegian Institute of Public Health
University Hospital, Akershus
Ostfold Hospital Trust
ThermoFisher Scientific Brahms Biomarkers France
University of Southampton
Imperial College London
Norwegian University of Life Sciences
Diakonova University College
Norwegian Department of Health and Social Affairs
University Medical Center Groningen
Furst Medical Laboratory
Information provided by (Responsible Party):
Karin C. Lødrup Carlsen, Oslo University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Food Allergy in Children Asthma Rhinitis, Allergic Non-communicable Diseases Obesity Cardiovascular Disease Other: Food intervention Other: Skin care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2702 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: International, multi-center, prospective 2x2 factorially designed randomized controlled trial of primary prevention in children of enrolled mother-child pairs, with an additional exploratory aim
Masking: Single (Investigator)
Masking Description: At all investigations, skin scoring is performed prior to any information from the study participants parents of intervention group. Also, no baths are allowed within 24 hours of investigation, to fascilitate blinding of the investigator to interventional allocation.
Primary Purpose: Prevention
Official Title: Preventing Atopic Dermatitis and ALLergies in Children
Study Start Date : December 14, 2014
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : June 2044

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Eczema

Arm Intervention/treatment
No Intervention: Observation only
Observation only
Experimental: Food intervention
Intervention; systematic introduction of egg, milk, wheat and peanut by 4 months of age
Other: Food intervention
Intervention; systematic introduction of egg, milk, wheat and peanut by 4 months of age

Experimental: Skin care
Intervention: regular baths with bath-oil 0.5-9 months of age
Other: Skin care
Bath with bath-oil aim and Ceridal face cream for least 5 times/ week from 0.5-9 months of age.
Other Name: PreventADALL bath oil

Experimental: Food intervention and skin care
Intervention; systematic introduction of egg, milk, wheat and peanut by 4 months of age Intervention: regular baths with bath-oil 0.5-9 months of age
Other: Food intervention
Intervention; systematic introduction of egg, milk, wheat and peanut by 4 months of age

Other: Skin care
Bath with bath-oil aim and Ceridal face cream for least 5 times/ week from 0.5-9 months of age.
Other Name: PreventADALL bath oil




Primary Outcome Measures :
  1. Atopic dermatitis (AD) [ Time Frame: 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,

  2. Food allergy to any intervention allergen [ Time Frame: 0-36 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


Secondary Outcome Measures :
  1. Allergic sensitisation (yes/no as well as quantitative, by skin prick test and s-IgE) [ Time Frame: first at 6 months, with follow-up investigations at 2 and 3 yrs and at intervals up to year 2044, provided funding ]
    (yes/no as well as quantitative, by skin prick test and s-IgE)

  2. Asthma (bronchial obstruction in year 1-2) [ Time Frame: first at 0-12 months, with follow-up investigations at 2 and 3 yrs and at intervals up to year 2044, provided funding ]
    In line with international criteria as used in Mechanisms of Allergy Development (MeDALL) criteria, and doctor diagnosis

  3. Food allergy to any other allergen [ Time Frame: 0-36 months, assessed first at 36 months of age, with follow-up investigations at intervals up to year 2044, provided funding ]
    As reported by parents, in line with international criteria and documentation from patient charts

  4. Anaphylaxis [ Time Frame: 0-36 months, assessed first at 36 months of age, with follow-up investigations at intervals up to year 2044, provided funding ]
    As reported by parents, with additional documentation from patient charts

  5. Rhinitis/Allergic rhinitis [ Time Frame: 12-36 months, with follow-up investigations at intervals up to year 2044, provided funding ]
    As reported by parents, in the absence (rhinitis) or presence (allergic rhinitis) of allergic sensitisation to inhalant allergens


Other Outcome Measures:
  1. Cardiovascular diseases [ Time Frame: Blood pressure 3-12 months of age, with follow-up investigations at 2 and 3 yrs and at intervals up to year 2044, provided funding ]
    Blood pressure measurements, defined by percentiles and quartiles. Not an outcome of the RCT but of the exploratory part of PreventADALL

  2. Diabetes [ Time Frame: at 36 months and with follow-up investigations at intervals up to year 2044, provided funding ]
    Clinical diagnosis from patient charts, not an outcome of the randomized clinical trial (RCT) but of the exploratory part of PreventADALL

  3. Obesity [ Time Frame: 0-12 months, with follow-up investigations at 2 and 3 yrs and at intervals up to year 2044, provided funding ]
    by international standards, based upon BMI adjusted for age and gender

  4. Any other allergic disease [ Time Frame: 0-12 months, with follow-up investigations at 2 and 3 yrs and at intervals up to year 2044, provided funding ]
    Venom or medication allergy, urticaria



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Enrollment of pregnant women, including their newborn babies of both genders
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02449850


Locations
Norway
Oslo University Hospital and University of Oslo
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Karolinska Institutet
Helsinki University Central Hospital
University of Lausanne Hospitals
Norwegian Institute of Public Health
University Hospital, Akershus
Ostfold Hospital Trust
ThermoFisher Scientific Brahms Biomarkers France
University of Southampton
Imperial College London
Norwegian University of Life Sciences
Diakonova University College
Norwegian Department of Health and Social Affairs
University Medical Center Groningen
Furst Medical Laboratory
Investigators
Principal Investigator: Karin C. Lødrup Carlsen, MD PhD Oslo University Hospital

Responsible Party: Karin C. Lødrup Carlsen, Professor MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02449850     History of Changes
Other Study ID Numbers: 2014-15118
First Posted: May 20, 2015    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017

Keywords provided by Karin C. Lødrup Carlsen, Oslo University Hospital:
In-utero environment
Asthma
Allergic diseases
Food allergy
Birth cohort study
Primary prevention
Intervention study
Atopic dermatitis
Rhinitis
Allergy
Lung function
Non-communicable diseases
Foetal growth
Obesity
Cardiovascular disease
Diabetes
Blood pressure
Anthropometric
Trans epidermic water loss

Additional relevant MeSH terms:
Cardiovascular Diseases
Dermatitis
Rhinitis
Hypersensitivity
Dermatitis, Atopic
Eczema
Food Hypersensitivity
Rhinitis, Allergic
Skin Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Immune System Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Respiratory Hypersensitivity