NCT02449850Active, not recruiting
Preventing Atopic Dermatitis and ALLergies in Children
Source: ClinicalTrials.gov · Last updated 29 Aug 2019
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 2701 (actual)
- First submitted
- 18 May 2015
- Start date
- 14 Dec 2014
- Primary completion date
- 31 Jul 2020
- Lead sponsor
- Oslo University Hospital
- Diseases
- Atopic dermatitis (eczema), Obesity, Asthma
- NCT number
- NCT02449850
What you commit to
- Study type: Interventional
- Participants enrolled: 2701
- From 14 Dec 2014 to the primary completion date, 31 Jul 2020
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 3\) Non-willingness to participate, 4) More than two foetuses
Who the study is looking for
- 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
Criteria the registry did not label
- The study enrolls Mother-child pairs in two steps; first mother, thereafter her new-born baby.
Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oslo University Hospital and University of Oslo Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.