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Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||N/A and Over|
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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Oslo University Hospital|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Karin C. Lødrup Carlsen, MD PhD|
|Principal Investigator Affiliation||Oslo University Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Active, not recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Atopic Dermatitis, Food Allergy in Children, Asthma, Rhinitis, Allergic, Non-communicable Diseases, Obesity, Cardiovascular Disease|
The PreventADALL study is a long term prospective birth cohort study, with an intervention aspect designed as a randomized clinical trial (RCT), and an exploratory aspect, enrolling mother-child pairs by including pregnant women, allowing for intrauterine investigations of the baby and maternal factors during pregnancy, and thereafter including their new-born babies for long-term follow-up investigations. With the knowledge that allergic diseases often manifest in early infancy, interventions will be carried out as early as possible to investigate if allergic diseases can be prevented. Two interventions, early and systematic introduction to common foods, and early skin care are carried out within the first four months and the first nine months of life, respectively. Inclusion/Exclusion criteria: 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. Exclusion: Plans to move further than reasonable travel distance from any of the participating hospitals within the first year of the offspring's life. 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 child: 1) severe neonatal cardiac, pulmonary, neurological, dermatological 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 fetuses Overall 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 continuing to at least 6 moths and preferentially continuing thereafter. Observation only after nine months of age. Recruitment is done in two steps; first pregnant women at the 18-weeks ultrasound investigation and thereafter their new-born babies. Randomisation into four groups is done by the postal code or "township" to ensure all four intervention-groups within each "township". Electronic questionnaires will be completed by the mother at 18 and 34 weeks gestation, as well as for the baby at 3-6-9-12-18-24-30-36 months and annually thereafter. Also, an electronic diary will be completed each week from 2-26 weeks of age, to register weekly interventions, as well as symptoms of allergic diseases and food intake. 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 annually thereafter. It is a hope that the study can be maintained well into adulthood. The study will be run in accordance with Good Clinical Practice (GCP). Investigations: Clinical investigations and biological sampling focuses on: General development, clinical assessments of health or disease, as well as diagnosing allergic disease and later also other non-communicable diseases (NCD)s. These include:
- - Fetal growth and respiratory development - Somatic growth and status (anthropometric data) - Blood pressure - Skin, respiratory, gastrointestinal and other relevant organs - Skin barrier (trans epidermal water loss (TEWL)) - Lung function and -development - Microbiota/diversity (in and on the body and the environment) - Viral infections - Immune-deviation/tolerance development - Specific allergen antibodies (IgE/IgG) - Xenobiotics and interactions between exposures (microbiota/xenobiotics) - Genetics/epi-genetics Outcome measures: Primary outcomes from birth to assessment times, first at 12 months of age for AD and at 36 months for food allergy to intervention allergens: 1.
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Oslo University Hospital and University of Oslo
Oslo, , 0424