Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Norway / NCT02449850
Active, not recruiting Not applicable

Preventing Atopic Dermatitis and ALLergies in Children

NCT02449850 · tracked via the Priya Life Science Norway tracker
Sponsor
Oslo University Hospital
Phase
Not applicable
Started
2014-12-14
Last updated
2019-08-29

Condition(s) studied

Atopic DermatitisFood Allergy in ChildrenAsthmaRhinitis, AllergicNon-communicable DiseasesObesityCardiovascular Disease

Investigational drug(s) / intervention(s)

Food interventionSkin care

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

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

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Oslo University Hospital and University of Oslo Oslo Norway

More Oslo University Hospital trials in Norway

Early Discovery of Ischemia After Replantation Surgery of the Extremities Active, not recruiting
Anal Cancer Radiotherapy Study Active, not recruiting
RAdiotherapy With FDG-PET Guided Dose-PAINTing for Primary Head and Neck Active, not recruiting
A Study of Enalapril in Treatment of Venous Malformations Recruiting
Treatment of Olecranon Fractures in the Elderly Recruiting

Other trials for the same condition

Effect of Exercise Training on Breastmilk Composition Active, not recruiting
A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis Active, not recruiting
Effect of Patient Education on Drinking Behaviour and Oral Hygiene in Patients Undergoing Bariatric Surgery Recruiting
NOR-SYS: The Norwegian Stroke in the Young Study Active, not recruiting
Alpha and Omega of Lifestyle Therapy Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02449850 on ClinicalTrials.gov ↗ ← All trials in Norway